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Sample records for alendronate treatment outcome

  1. Alendronate

    MedlinePlus

    ... Alendronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing ... treatment.you should know that alendronate may cause osteonecrosis of the jaw (ONJ, a serious condition of ...

  2. Dental enamel dissolution after alendronate treatment.

    PubMed

    Gandolfi, Maria G; Nucci, Cesare; Prati, Carlo; Mongiorgi, Romano

    2007-08-01

    To evaluate the effect of treatment with a bisphosphonate (alendronate) on human dental enamel dissolution in vitro. The dissolution of each enamel sample was evaluated by monitoring the calcium release in 0.1M lactic acid solution at pH 4.5 (acidic solution) during dissolution tests, after topical alendronate treatment with 0.1M alendronate solutions at pH 5.0, pH 7.4 and pH 9.0. Data showed that alendronate treatment, both at pH 5.0 and pH 7.4, obtained a statistically significant reduction of enamel demineralization during dissolution test reaction time (45 minutes). The protective effect was not present after treatment at pH 9.

  3. Impact of generic alendronate cost on the cost-effectiveness of osteoporosis screening and treatment.

    PubMed

    Nayak, Smita; Roberts, Mark S; Greenspan, Susan L

    2012-01-01

    Since alendronate became available in generic form in the Unites States in 2008, its price has been decreasing. The objective of this study was to investigate the impact of alendronate cost on the cost-effectiveness of osteoporosis screening and treatment in postmenopausal women. Microsimulation cost-effectiveness model of osteoporosis screening and treatment for U.S. women age 65 and older. We assumed screening initiation at age 65 with central dual-energy x-ray absorptiometry (DXA), and alendronate treatment for individuals with osteoporosis; with a comparator of "no screening" and treatment only after fracture occurrence. We evaluated annual alendronate costs of $20 through $800; outcome measures included fractures; nursing home admission; medication adverse events; death; costs; quality-adjusted life-years (QALYs); and incremental cost-effectiveness ratios (ICERs) in 2010 U.S. dollars per QALY gained. A lifetime time horizon was used, and direct costs were included. Base-case and sensitivity analyses were performed. Base-case analysis results showed that at annual alendronate costs of $200 or less, osteoporosis screening followed by treatment was cost-saving, resulting in lower total costs than no screening as well as more QALYs (10.6 additional quality-adjusted life-days). When assuming alendronate costs of $400 through $800, screening and treatment resulted in greater lifetime costs than no screening but was highly cost-effective, with ICERs ranging from $714 per QALY gained through $13,902 per QALY gained. Probabilistic sensitivity analyses revealed that the cost-effectiveness of osteoporosis screening followed by alendronate treatment was robust to joint input parameter estimate variation at a willingness-to-pay threshold of $50,000/QALY at all alendronate costs evaluated. Osteoporosis screening followed by alendronate treatment is effective and highly cost-effective for postmenopausal women across a range of alendronate costs, and may be cost-saving at

  4. Alendronate treatment of naturally-occurring periodontitis in beagle dogs.

    PubMed

    Reddy, M S; Weatherford, T W; Smith, C A; West, B D; Jeffcoat, M K; Jacks, T M

    1995-03-01

    The treatment of periodontal disease has been largely directed at the microbiological etiology. The prevention of bone loss by modulating the host response to the bacteria may be a useful adjunctive method in the management of periodontitis. Alendronate, an amino bisphosphonate, may inhibit bone loss in osteolytic diseases by altering osteoclast activity. The objective of this double-blind study was to evaluate alendronate inhibition of alveolar bone loss in the naturally occurring beagle dog model of periodontitis. Sixteen 7 to 9 year old beagles with moderate-to-severe periodontitis were studied for 6 months. The dogs were stratified into two groups based on initial periodontal severity. One group received 3.0 mg/kg alendronate weekly orally and the other group received a placebo. Silk ligatures were placed on the study teeth for the first 3 months of the study to exacerbate the periodontal destruction. Clinical data were collected for attachment level, gingival index, plaque index, and mobility at baseline and one-month intervals. Intraoral radiographs were made at baseline and at 3 and 6 months. The mandibles were processed for histology at month 6. The radiographs were analyzed by digital image analysis of the subtracted images. A statistically significant difference in bone mass (P < 0.001) was observed between the alendronate and placebo groups. The bisphosphonate had no effect on the clinical parameters of gingival inflammation or plaque. A trend toward decreased attachment loss and mobility was observed in favor of the alendronate group.(ABSTRACT TRUNCATED AT 250 WORDS)

  5. Effects of teriparatide versus alendronate for treatment of postmenopausal osteoporosis: A meta-analysis of randomized controlled trials.

    PubMed

    Wang, Ya-Kang; Qin, Si-Qing; Ma, Tao; Song, Wei; Jiang, Ren-Qi; Guo, Jian-Bin; Li, Kun; Zhang, Yu-Min

    2017-05-01

    Osteoporosis remains a clinical challenge. Teriparatide is an anabolic drug and alendronate is an antiresorptive agent; both are used in the treatment of osteoporosis. Comprehensive reviews investigating the comparative safety and efficacy of teriparatide versus alendronate are scarce. Therefore, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the safety and efficacy of teriparatide versus alendronate for the treatment of postmenopausal osteoporosis. We conducted a comprehensive literature review of the PubMed, EMBASE, Cochrane Controlled Trials Registry, and the China Academic Journal Network Publishing databases for relevant RCTs of teriparatide versus alendronate in postmenopausal osteoporosis patients. Outcome measures were percentage change in lumbar spine and femoral neck bone mineral density (BMD) and incidence of vertebral and nonvertebral fractures. Effect size was reported as weighted mean differences (WMDs) for continuous outcomes and odds ratios (OR) for dichotomous outcomes, with associated 95% confidence intervals (CIs). Six trials involving 618 patients were included. The meta-analysis demonstrated a significant increase in lumbar spine BMD (WMD: 3.46, 95% CI: 2.15-4.77, P < .00001), but not femoral neck BMD (WMD = 1.50, 95% CI: 0.04-2.95, P = .04), in postmenopausal osteoporosis patients treated with teriparatide compared with alendronate for 6 to 18 months. These beneficial effects were apparent in the lumbar spine at 12 months of treatment (WMD: 4.49, 95% CI: 2.57-6.40, P < .01). Teriparatide was not superior to alendronate in reducing fracture risk (OR: -0.03, 95% CI: -0.12 to 0.07; P = .52). Teriparatide may be superior to alendronate for increasing lumbar spine BMD in postmenopausal osteoporosis. The efficacy and safety of long-term teriparatide and alendronate treatment in postmenopausal osteoporosis should be further investigated in clinical trials.

  6. A critical review of brand and generic alendronate for the treatment of osteoporosis.

    PubMed

    Brown, Jacques P; Davison, Kenneth S; Olszynski, Wojciech P; Beattie, Karen A; Adachi, Jonathan D

    2013-01-01

    Compare in vitro and in vivo characteristics and clinical outcomes of brand and generic alendronate. Relevant search terms were input into Medline ("alendronate" AND "generic" up to August 5, 2013) and any abstracts deemed possibly relevant selected for full paper review and abstraction. Multicentre, randomized, placebo-controlled Phase III clinical trials of substantial size and duration have established the anti-fracture efficacy and safety of brand amino-bisphosphonates. For regulatory approval, generic versions of brand drugs need to demonstrate bioequivalence in young, healthy volunteers and have similar dissolution times. While the potency and amount of active drug within generic formulations must be identical to the brand, differences are permitted in the excipients. Significant differences in tablet disintegration time among different versions of generic and brand alendronate have been reported. Rapidly disintegrating alendronate pills may increase oesophageal bioadhesion and adverse event risk. Oesophageal-bound alendronate or slow disintegrating alendronate tablets may be made inert and ineffective by subsequently ingested food or drink. Investigations have reported a lower persistence to therapy with generic brands of alendronate as compared to brand bisphosphonates and patients switched from brand to generic alendronate have increased adverse event rates and losses in bone mineral density. Numerous differences exist between brand and generic alendronate including: disintegration time, bioadhesion to the oesophagus, patient persistence to therapy, adverse event incidence, and maintenance of bone mineral density. Generic forms of alendronate warrant closer clinical study before they are ascribed the clinical effectiveness and tolerability of brand alendronate.

  7. A Randomized, Double Blind, Placebo-Controlled Trial of Alendronate Treatment for Fibrous Dysplasia of Bone

    PubMed Central

    Boyce, Alison M.; Kelly, Marilyn H.; Brillante, Beth A.; Kushner, Harvey; Wientroub, Shlomo; Riminucci, Mara; Bianco, Paolo; Robey, Pamela G.

    2014-01-01

    Context: Fibrous dysplasia (FD) is a rare skeletal disorder, resulting in deformity, fracture, functional impairment, and pain. Bisphosphonates have been advocated as a potential treatment. Objective: To determine the efficacy of alendronate for treatment of FD. Design: Two-year randomized, double-blind, placebo-controlled trial. Setting: Clinical research center. Patients: Forty subjects with polyostotic FD (24 adults, 16 children). Subjects were randomized and stratified by age. Interventions: Study drug was administered over a 24 month period in 6 month cycles (6 months on, 6 months off). Alendronate dosing was stratified: 40 mg daily for subjects >50 kg, 20 mg for 30–50 kg, 10 mg for 20–30 kg. Main Outcome Measures: Primary endpoints were bone turnover markers, including serum osteocalcin, and urinary NTX-telopeptides. Secondary endpoints included areal bone mineral density (aBMD), pain, skeletal disease burden score, and functional parameters including the 9-min walk test and manual muscle testing. Results: Clinical data was collected on 35 subjects who completed the study. There was a decline in NTX-telopeptides in the alendronate group (P = .006), but no significant difference in osteocalcin between groups. The alendronate group had an increase in areal BMD in normal bone at the lumbar spine (P = .006), and in predetermined regions of FD (P < .001). There were no significant differences in pain scores, skeletal disease burden scores, or functional parameters between the groups. Conclusions: Alendronate treatment led to a reduction in the bone resorption marker NTX-telopeptides, and improvement in aBMD, but no significant effect on serum osteocalcin, pain, or functional parameters. PMID:25033066

  8. Superiority of a combined treatment of Alendronate and Alfacalcidol compared to the combination of Alendronate and plain vitamin D or Alfacalcidol alone in established postmenopausal or male osteoporosis (AAC-Trial).

    PubMed

    Ringe, J D; Farahmand, P; Schacht, E; Rozehnal, A

    2007-03-01

    A combined therapy with the strongly antiresorptive Alendronate and the pleiotropically acting D-hormone analogue Alfacalcidol may have additive effects on bone quality, falls and fracture risk in established osteoporosis. The aim of this study (Alfacalcidol Alendronate Combined-AAC) was to compare the efficacy and safety of a combined parallel therapy with Alendronate and Alfacalcidol to the treatment with either Alendronate in combination with plain vitamin D or Alfacalcidol alone in patients with established postmenopausal or male osteoporosis. Ninety patients were included as matched triplets to receive randomly either 1 microg Alfacalcidol daily + 500 mg calcium (group A, n = 30) or 70 mg Alendronate weekly + 1,000 mg calcium + 1,000 IU vitamin D daily (group B, n = 30) or 1 microg Alfacalcidol daily + 70 mg Alendronate weekly + 500 mg calcium daily (group C, n = 30). Patients were recruited in one centre and were followed up for 24 months. Analysis was intention-to-treat and the primary outcome was lumbar spine and total hip bone mineral density (measured observer blind). BMD was measured at the lumbar spine and at the proximal femur with dual energy X-ray absorptiometry (LUNAR Prodigy, GE, USA) at the beginning and after 12 and 24 months. During the 2-year-study we observed descriptively significant increases at the lumbar spine of 3.0% in group A compared to baseline, of 5.4% in group B and of 9.6% in group C, respectively. The superiority of the Alendronate + Alfacalcidol treatment group over Alfacalcidol alone and over Alendronate + vitamin D was of more than large rele-vance (both tests: MW > 0.71; CI-LB > 0.64; P < 0.001). We also observed median increases of the BMD at the total hip of 1.5% in group A, of 2.4% in group B and of 3.8% in group C, respectively. The superiority of group C over group A and over group B again was relevant and statistically significant in a descriptive sense. After 2 years there was a tendency towards higher rates of

  9. Effect of three years of oral alendronate treatment in postmenopausal women with osteoporosis.

    PubMed

    Tucci, J R; Tonino, R P; Emkey, R D; Peverly, C A; Kher, U; Santora, A C

    1996-11-01

    Oral alendronate sodium is a potent, specific inhibitor of osteoclast-mediated bone resorption. To assess its efficacy and safety, a 3-year, randomized, double-blind, multicenter study of 478 postmenopausal women with osteoporosis was conducted. Subjects received either placebo, alendronate 5 or 10 mg/day for 3 years, or 20 mg/day for 2 years followed by 5 mg/day for 1 year (20/5 mg). All subjects received 500 mg/day of supplemental calcium. Bone mineral density (BMD) was measured by dual energy x-ray absorptiometry (DXA). After 3 years, alendronate 10 mg induced marked increases in BMD of the lumbar spine (9.6 +/- 0.4%), femoral neck (4.7 +/- 0.7%) and trochanter (7.4 +/- 0.6%) (mean +/- SE; each P < or = 0.001) versus decreases of 0.8 to 1.6% with placebo. Progressive increases at these sites in the alendoronate 10 mg group were significant during both the second and third years. Alendronate 10 mg increased total body BMD (1.6 +/- 0.3%, P < or = 0.001), and prevented loss but did not increase BMD at the 1/3 forearm site. Alendronate 20/5 mg was no more effective, whereas alendronate 5 mg was significantly less effective than 10 mg at all sites. Bone turnover decreased to a stable nadir over 3 months for resorption markers (urine deoxypyridinoline) and over 6 months for formation markers (alkaline phosphatase and osteocalcin). Mean loss of stature was reduced by 41% in alendronate treated subjects (P = 0.01). The safety profile of alendronate was similar to that of placebo. At 10 mg, there were no trends toward increased frequency of any adverse experience except for abdominal pain, which was usually mild, transient, and resolved with continued treatment. Thus, alendronate appears to be an important advance in the treatment of osteoporosis in postmenopausal women.

  10. Experience with alendronate treatment for 7 years among Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures.

    PubMed

    Iwamoto, Jun; Uzawa, Mitsuyoshi

    2016-01-01

    A retrospective study was performed to evaluate the outcome of alendronate treatment for 7 years among Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures. Thirty-five Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures (mean age at baseline 58.2 years) who had been treated with alendronate for over 7 years in our outpatient clinic were analyzed. The lumbar spine or total hip bone mineral density (BMD) was measured using dual energy X-ray absorptiometry; the urinary levels of cross-linked N-terminal telopeptides of type I collagen (NTX) and the serum levels of alkaline phosphatase (ALP) were monitored; the incidence of fractures during the 7-year treatment period was then assessed. The urinary NTX and serum ALP levels decreased (-46.1% at 3 months and -21.1% at 7 years, respectively) and the lumbar spine and total hip BMD increased (+14.2 and +10.1% at 7 years, respectively), compared with the baseline values. Four patients (11.4%) experienced vertebral fractures, and one patient (2.9%) experienced a nonvertebral fracture. No serious adverse events were observed, including osteonecrosis of the jaw or atypical femoral fractures. These results suggested that alendronate suppressed bone turnover and increased the lumbar spine and total hip BMD from the baseline values over the course of the 7-year treatment period without causing any severe adverse events in Japanese men with osteoporosis or osteopenia and clinical risk factors for fractures.

  11. Atypical Fracture of the Sternum After Long-Term Alendronate Plus Cholecalciferol Treatment: A Case Report.

    PubMed

    Martín Arias, Luis H; García Ortega, Pilar; Sáinz Gil, María; Navarro García, Ester; Treceño Lobato, Carlos; Delgado Armas, Virginia

    2017-12-01

    A 55-year-old woman developed an atraumatic sternum fracture during treatment with alendronate for osteoporosis. The woman received alendronate 70 mg in combination with cholecalciferol 5600 IU once weekly, as well as nonsteroidal anti-inflammatory drugs. After 4 years of treatment, following a dorsal flexion with no direct thoracic trauma, the patient suffered a fracture of the sternum, with an X-ray revealing sternal body fracture. This fracture was seen to be transverse, noncomminuted and without displacement. Magnetic resonance imaging was carried out to rule out the presence of either a pathological fracture or a fracture resulting from osteoporotic fragility, and showed a triple sternal fracture involving the body, as well as the upper and lower manubrium of the sternum. This fracture presented the features of an atypical femur fracture, except for the location. The alendronate and cholecalciferol combination was discontinued and denosumab was prescribed. After the withdrawal of alendronate, the patient showed clinical improvement, with a decrease in pain, and is currently having routine checkups. The causality algorithm of the Spanish Pharmacovigilance System shows a score of 5, indicating a possible relationship between the patient's sternum fracture and her use of the suspect drug (Naranjo scale 6 = probable).

  12. The effect of alendronate treatment on cortical thickness of the proximal femur in postmenopausal women

    PubMed Central

    Mobini, Maryam; Dehghan, Leyla; Yosefi, Gholamali; Mohammadpour, Alireza; Abdi, Rohollah

    2016-01-01

    Background: Bisphosphonates (BPs) are used extensively for managing the osteoporosis. There are some controversies on atypical fractures of femur that associated with increase in cortical thickness (CT) and BPs’ use. In this study, the effects of alendronate consumption were studied on femoral CT as a predictor for atypical fracture. Methods: Forty nine post-menopausal women aged 50-70 years with osteopenia-osteoporosis who were treated with alendronate 70 mg/week for at least one year were compared to 49 controls for CT in subtrochanteric region of femur by hip dual-energy X-ray absorptiometry (DXA) scans and hip Xray. CT and its ratio were measured at 3.5 and 4.0 cm below the tip of the greater trochanter (GT) and 0.5 cm below lesser trochanter (LT) in DXA and at 9.5 and 10.5 cm of GT and 1 cm of LT in Xray. Results: In this study, 98 women participated whose mean age and age at menopause were 60 (17±5.6) and 49 (40±2.7) years, respectively. Duration of BP consumption in alendronate group was 1.76±1.38 (1-10) years. No difference was seen in the mean of CT and its ratio between the alendronate and control groups in BMD scan or X-ray. The best correlation between two imaging modalities was in cortical ratio in 3.5 cm of GT in BMD scan and 9.5 cm of GT in X-ray. Conclusion: Alendronate treatment did not appear to increase femoral CT throughout the detection limits of BMD scan or X-ray. PMID:27390698

  13. The effect of alendronate treatment on cortical thickness of the proximal femur in postmenopausal women.

    PubMed

    Mobini, Maryam; Dehghan, Leyla; Yosefi, Gholamali; Mohammadpour, Alireza; Abdi, Rohollah

    2016-01-01

    Bisphosphonates (BPs) are used extensively for managing the osteoporosis. There are some controversies on atypical fractures of femur that associated with increase in cortical thickness (CT) and BPs' use. In this study, the effects of alendronate consumption were studied on femoral CT as a predictor for atypical fracture. Forty nine post-menopausal women aged 50-70 years with osteopenia-osteoporosis who were treated with alendronate 70 mg/week for at least one year were compared to 49 controls for CT in subtrochanteric region of femur by hip dual-energy X-ray absorptiometry (DXA) scans and hip Xray. CT and its ratio were measured at 3.5 and 4.0 cm below the tip of the greater trochanter (GT) and 0.5 cm below lesser trochanter (LT) in DXA and at 9.5 and 10.5 cm of GT and 1 cm of LT in Xray. In this study, 98 women participated whose mean age and age at menopause were 60 (17±5.6) and 49 (40±2.7) years, respectively. Duration of BP consumption in alendronate group was 1.76±1.38 (1-10) years. No difference was seen in the mean of CT and its ratio between the alendronate and control groups in BMD scan or X-ray. The best correlation between two imaging modalities was in cortical ratio in 3.5 cm of GT in BMD scan and 9.5 cm of GT in X-ray. Alendronate treatment did not appear to increase femoral CT throughout the detection limits of BMD scan or X-ray.

  14. Serum ionic fluoride concentrations are significantly decreased after treatment with alendronate in patients with osteoporosis.

    PubMed

    Sato, Hironori; Tanno, Kozo; Muro-oka, Genyoh; Itai, Kazuyoshi

    2011-11-20

    We determined serum ionic fluoride (SIF) concentrations before and after treatment of osteoporosis with alendronate to clarify whether SIF concentrations directly reflect a change in bone metabolism. A total of 45 postmenopausal women with primary osteoporosis who were treated with alendronate over a 6-month period were enrolled (mean age, 64.2 years). SIF concentrations were measured by the flow injection method with an ion-selective electrode. Concentrations of bone turnover markers (serum bone alkaline phosphatase, serum osteocalcin, serum type I collagen cross-linked N-telopeptide and urinary deoxypryridinoline) and lumbar spine BMD (LsBMD) were also measured. SIF, bone turnover markers and LsBMD before and after treatment were compared. Concentrations of SIF as well as concentrations of all bone turnover markers were significantly decreased after treatment: means (standard deviations) before and after treatment were 0.62 (0.13) and 0.32 (0.09) μmol/l, respectively (P<0.001) and the percent change was -46.3%. LsBMD was also significantly increased by 6.7% after treatment. The reduction of SIF concentrations is probably caused by inhibition of bone resorption due to the action of alendronate. The findings suggest that SIF concentrations directly reflect a change in bone metabolism. Copyright © 2011 Elsevier B.V. All rights reserved.

  15. Bone Mass Outcomes in Patients With Osteoporosis Treated With Risedronate After Alendronate Failure: a 12-Month Follow-Up Study.

    PubMed

    Mendonça, Leonardo Teixeira; Pinheiro, Marcelo Medeiros; Szejnfeld, Vera Lúcia; Castro, Charlles Heldan de Moura

    Oral bisphosphonates are the drugs most frequently used for the treatment of osteoporosis. Clinicians usually switch between these drugs in clinical practice based on differences in efficacy. We aim to investigate the reasons associated with switching between oral bisphosphonates and to evaluate bone mass response and the incidence of fractures 12 mo after the exchange in a cohort of patients with osteoporosis seen at a tertiary hospital. Patients with osteoporosis who switched between oral bisphosphonates between January 2007 and December 2014 were included. Bone mass measured by dual-energy X-ray absorptiometry and the incidence of fracture were evaluated. A total of 112 patients (73.1 yr old on average, 95.5% women, 98% postmenopausal) were included. All patients were taking alendronate at the time of the switch to risedronate. In 91 patients (81.3%), the following reasons for the exchange of medication were identified: bone loss (59.8%), adverse events (11.6%), and recent fragility fracture (10.7%). One year after the switch, bone densitometry revealed bone loss in 51 patients (45.5%), bone mass maintenance in 34 (30.4%), and bone mass gain in 27 (24.1%). No new vertebral fracture was detected and no nonvertebral fracture was reported in 12 mo of follow-up. Bone mass outcomes (gain, loss, or maintenance) were not associated with the reason for switching between oral bisphosphonates. Similarly, none of the parameters evaluated could predict good densitometric response (gain or maintenance) in this scenario. Our findings suggest that the use of risedronate should not be recommended in the scenario of treatment failure or adverse events following the use of alendronate.

  16. Effects of combination treatment with alendronate and raloxifene on skeletal properties in a beagle dog model

    PubMed Central

    McNerny, Erin; Aref, Mohammad; Organ, Jason M.; Newman, Christopher L.; McGowan, Brian; Jang, Tim; Burr, David B.; Brown, Drew M.; Hammond, Max; Territo, Paul R.; Lin, Chen; Persohn, Scott; Jiang, Lei; Riley, Amanda A.; McCarthy, Brian P.; Hutchins, Gary D.; Wallace, Joseph M.

    2017-01-01

    A growing number of studies have investigated combination treatment as an approach to treat bone disease. The goal of this study was to investigate the combination of alendronate and raloxifene with a particular focus on mechanical properties. To achieve this goal we utilized a large animal model, the beagle dog, used previously by our laboratory to study both alendronate and raloxifene monotherapies. Forty-eight skeletally mature female beagles (1–2 years old) received daily oral treatment: saline vehicle (VEH), alendronate (ALN), raloxifene (RAL) or both ALN and RAL. After 6 and 12 months of treatment, all animals underwent assessment of bone material properties using in vivo reference point indentation (RPI) and skeletal hydration using ultra-short echo magnetic resonance imaging (UTE-MRI). End point measures include imaging, histomorphometry, and mechanical properties. Bone formation rate was significantly lower in iliac crest trabecular bone of animals treated with ALN (-71%) and ALN+RAL (-81%) compared to VEH. In vivo assessment of properties by RPI yielded minimal differences between groups while UTE-MRI showed a RAL and RAL+ALN treatment regimens resulted in significantly higher bound water compared to VEH (+23 and +18%, respectively). There was no significant difference among groups for DXA- or CT-based measures lumbar vertebra, or femoral diaphysis. Ribs of RAL-treated animals were smaller and less dense compared to VEH and although mechanical properties were lower the material-level properties were equivalent to normal. In conclusion, we present a suite of data in a beagle dog model treated for one year with clinically-relevant doses of alendronate and raloxifene monotherapies or combination treatment with both agents. Despite the expected effects on bone remodeling, our study did not find the expected benefit of ALN to BMD or structural mechanical properties, and thus the viability of the combination therapy remains unclear. PMID:28793321

  17. The bone architecture is enhanced with combined PTH and alendronate treatment compared to monotherapy while maintaining the state of surface mineralization in the OVX rat.

    PubMed

    Campbell, Graeme M; Bernhardt, R; Scharnweber, D; Boyd, Steven K

    2011-08-01

    This study examined the effect of PTH and alendronate alone and in combination on the bone architecture, mineralization, and estimated mechanics in the OVX rat. Female Wistar rats aged 7-9months were assigned to one of five groups: (1) sham+vehicle, (2) OVX+vehicle, (3) OVX+PTH, (4) OVX+alendronate, and (5) OVX+PTH and alendronate. Surgery was performed at baseline (week 0), and biweekly treatment (15μg/kg of alendronate and/or daily (5days/week) 40μg/kg hPTH(1-34)) was administered from week 6 to week 14. Micro-CT scans of the right proximal tibial metaphysis were made in vivo at weeks 0, 6, 8, 10, 12 and 14 and measurements of bone microarchitecture and estimated mechanical parameters (finite element analysis) were made from the images. Synchrotron radiation micro-CT scans of the proximal tibia and fourth lumbar vertebrae were conducted ex vivo at the study endpoint to determine the degree and spatial distribution of the bone mineralization. Alendronate preserved the microarchitecture after OVX, and increased cortical (9%, p<0.05) and trabecular thickness (5%, p<0.05). PTH mono- and combined therapy induced increases in cortical (25-35%, p<0.05) and trabecular thicknesses (46-48%, p<0.05), resulting in a full restoration of bone volume in the PTH group, and an increase beyond baseline in the combined group. Improvements in estimated mechanical outcomes were observed in all treatment groups by the end of the study, with the combined group experiencing the greatest increase in predicted stiffness (63%, p<0.05). Alendronate treatment increased the peak mineral content above the other treatment groups at the trabecular (tibia: 6% above PTH, 6% above combined, L4: 4% above PTH, 4% above combined) and endocortical (tibia: 4% above PTH, 3% above combined, L4: 1% above PTH, 2% above combined) surfaces, while no differences in mineralization between the PTH and combined groups were observed. Combined treatment resulted in more pronounced improvements of the bone

  18. Effectiveness of alendronate as an adjunct to scaling and root planing in the treatment of periodontitis: a meta-analysis of randomized controlled clinical trials

    PubMed Central

    2016-01-01

    Purpose Alendronate has been proposed as a local and systemic drug treatment used as an adjunct to scaling and root planing (SRP) for the treatment of periodontitis. However, its effectiveness has yet to be conclusively established. The purpose of the present meta-analysis was to assess the effectiveness of SRP with alendronate on periodontitis compared to SRP alone. Methods Five electronic databases were used by 2 independent reviewers to identify relevant articles from the earliest records up to September 2016. Randomized controlled trials (RCTs) comparing SRP with alendronate to SRP with placebo in the treatment of periodontitis were included. The outcome measures were changes in bone defect fill, probing depth (PD), and clinical attachment level (CAL) from baseline to 6 months. A fixed-effect or random-effect model was used to pool the extracted data, as appropriate. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Heterogeneity was assessed using the Cochrane χ2 and I2 tests. Results After the selection process, 8 articles were included in the meta-analysis. Compared with SRP alone, the adjunctive mean benefits of locally delivered alendronate were 38.25% for bone defect fill increase (95% CI=33.05–43.45; P<0.001; I2=94.0%), 2.29 mm for PD reduction (95% CI=2.07–2.52 mm; P<0.001; I2=0.0%) and 1.92 mm for CAL gain (95% CI=1.55–2.30 mm; P<0.001; I2=66.0%). In addition, systemically administered alendronate with SRP significantly reduced PD by 0.36 mm (95% CI=0.18–0.55 mm; P<0.001; I2=0.0%) and increased CAL by 0.39 mm (95% CI=0.11–0.68 mm; P=0.006; I2=6.0%). Conclusions The collective evidence regarding the adjunctive use of alendronate locally and systemically with SRP indicates that the combined treatment can improve the efficacy of non-surgical periodontal therapy on increasing CAL and bone defect fill and reducing PD. However, precautions must be exercised in interpreting these results, and multicenter studies evaluating

  19. Randomized clinical trial comparing efficacy and safety of brand versus generic alendronate (Bonmax®) for osteoporosis treatment.

    PubMed

    Unnanuntana, Aasis; Jarusriwanna, Atthakorn; Songcharoen, Panupan

    2017-01-01

    Although the same efficacy and tolerability are anticipated due to both drugs containing the same active ingredients, comparative studies between brand and generic alendronate are limited. Accordingly, the objective of this study was to compare efficacy and safety between brand alendronate and a recently introduced generic alendronate drug. A total of 140 postmenopausal women or men aged older than 50 years who met the indications for osteoporosis treatment were randomized to receive either generic (Bonmax®) or brand alendronate (Fosamax®) 70 mg/week over a 12-month period during the May 2014 to June 2015 study period. Endpoints included bone mineral density (BMD) changes at the lumbar spine, total hip, and femoral neck; percentage of patients with predefined levels of change in total hip and lumbar spine BMD at 12 months; and, changes in biochemical bone markers at 3, 6, and 12 months. Tolerability was evaluated by patient self-reporting of adverse experiences. At 12 months post-treatment, BMD significantly increased at all sites in both groups. There were no differences in BMD percentage changes or the number of patients with stable or increased BMD after 1 year between groups. No significant differences in the amount of biochemical bone marker reduction or incidence of adverse events were observed between groups. Generic and brand alendronate produced similar gains in BMD and reduction in bone turnover markers. Both medicadoitions were also equally well-tolerated. Based on these findings, generic alendronate (Bonmax®) is a viable alternative to the original brand of alendronate. ClinicalTrials.gov NCT02371252.

  20. Surgical treatment of bilateral femoral stress fractures related with long-term alendronate therapy.

    PubMed

    Kanatlı, Ulunay; Ataoğlu, M Baybars; Özer, Mustafa; Topçu, H Nevzat; Çetinkaya, Mehmet

    2017-04-01

    A 67-year-old female patient admitted to our outpatient clinic suffering from pain in both thighs for one year without any history of trauma. Patient was receiving alendronate therapy for five years. Physical examination revealed pain increasing with weight-bearing in both thighs with full range of hip and knee movements. Radiographs showed an area of thickened cortex of middle femoral diaphysis in both femurs, but no fracture. Bone scan showed a single area of increased uptake of radioisotope. These images were compatible with stress fractures of both femurs. Dual-energy X-ray absorptiometry revealed a T-score of -3.2 for the lumbar spine and -3.5 for the hip. Alendronate treatment was ceased. Calcium and vitamin D treatment were started. Patient was performed prophylactic surgical stabilization by titanium elastic nails in May 2009. On first day after the surgery, unsupported mobilization and weight-bearing activities were started. Upon persistence of pain on left thigh, plate fixation was performed for the nonunion in June 2012. Patient is now pain-free and able to walk with full weight-bearing without any complications.

  1. Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial.

    PubMed

    Dutra, Bernardo Carvalho; Oliveira, Alcione Maria Soares Dutra; Oliveira, Peterson Antônio Dutra; Manzi, Flavio Ricardo; Cortelli, Sheila Cavalca; Cota, Luís Otávio de Miranda; Costa, Fernando Oliveira

    2017-01-01

    Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy.

  2. Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial

    PubMed Central

    DUTRA, Bernardo Carvalho; OLIVEIRA, Alcione Maria Soares Dutra; OLIVEIRA, Peterson Antônio Dutra; MANZI, Flavio Ricardo; CORTELLI, Sheila Cavalca; COTA, Luís Otávio de Miranda; COSTA, Fernando Oliveira

    2017-01-01

    Abstract Background and objectives Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Material and Methods Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Results Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Conclusions Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy. PMID:28678950

  3. Once weekly alendronate.

    PubMed

    Sambrook, Philip

    2003-05-01

    Alendronate, a bisphosphonate that potently inhibits bone resorption, has been shown in long-term clinical trials to be an effective treatment for osteoporosis, increasing bone mineral density and substantially reducing the incidence of both vertebral and nonvertebral fractures, including hip fractures, mostly using a daily dosage regimen. Although daily administration has generally been well tolerated in these trials, some patients develop upper gastrointestinal symptoms. Current safety and efficacy data suggest that once-weekly dosing of alendronate appears to be as efficacious as daily administration in the treatment of osteoporosis, providing greater convenience to patients, improved compliance and a lower risk of upper gastrointestinal symptoms compared with daily administration. This review examines published data addressing the safety and efficacy of once-weekly alendronate administration.

  4. The analysis of DKK1 polymorphisms in relation to skeletal phenotypes and bone response to alendronate treatment in Chinese postmenopausal women.

    PubMed

    Wang, Jian-yi; Zhou, Pei-ran; Liu, Yi; Xu, Xiao-jie; Ma, Dou-dou; Xia, Wei-bo; Jiang, Yan; Wang, Ou; Xing, Xiao-ping; Li, Mei

    2016-02-01

    To investigate the correlation between DKK1 polymorphisms with bone phenotypes and response to alendronate treatment. Five tag single nucleotide polymorphisms of DKK1 were analyzed in 639 Chinese postmenopausal women with osteoporosis or osteopenia. Bone mineral density (BMD), β-CTX and ALP were measured before and after alendronate treatment. Genotypes at rs1896367, rs1528877 and rs2241529 correlated to baseline BMD (p < 0.05). rs1528877 and rs2241529 polymorphisms correlated to baseline β-CTX levels (p < 0.05). rs2241529 polymorphisms of DKK1 had a small influence on the skeletal response to alendronate treatment (p < 0.05). DKK1 polymorphisms may correlate to baseline BMD and serum β-CTX levels, but present a weak effect on the response to alendronate.

  5. EFFECTS OF LONG-TERM ALENDRONATE TREATMENT ON A LARGE SAMPLE OF PEDIATRIC PATIENTS WITH OSTEOGENESIS IMPERFECTA.

    PubMed

    Lv, Fang; Liu, Yi; Xu, Xiaojie; Wang, Jianyi; Ma, Doudou; Jiang, Yan; Wang, Ou; Xia, Weibo; Xing, Xiaoping; Yu, Wei; Li, Mei

    2016-12-01

    Osteogenesis imperfecta (OI) is a group of inherited diseases characterized by reduced bone mass, recurrent bone fractures, and progressive bone deformities. Here, we evaluate the efficacy and safety of long-term treatment with alendronate in a large sample of Chinese children and adolescents with OI. In this prospective study, a total of 91 children and adolescents with OI were included. The patients received 3 years' treatment with 70 mg alendronate weekly and 500 mg calcium daily. During the treatment, fracture incidence, bone mineral density (BMD), and serum levels of the bone turnover biomarkers (alkaline phosphatase [ALP] and cross-linked C-telopeptide of type I collagen [β-CTX]) were evaluated. Linear growth speed and parameters of safety were also measured. After 3 years of treatment, the mean annual fracture incidence decreased from 1.2 ± 0.8 to 0.2 ± 0.3 (P<.01). BMD at the lumbar spine and femoral neck significantly increased by 74.6% and 39.5%, with their BMD Z-score increasing from -3.0 to 0.1 and from -4.2 to -1.3, respectively (both P<.01 vs. baseline). In addition, serum ALP and β-CTX levels decreased by 35.6% and 44.3%, respectively (both P<.05 vs. baseline). Height significantly increased, but without an obvious increase in its Z-score. Patient tolerance of alendronate was good. Three years' treatment with alendronate was demonstrated for the first time to significantly reduce fracture incidence, increase lumbar spine and femoral neck BMD, and decrease bone turnover biomarkers in Chinese children and adolescents with OI. ALP = alkaline phosphatase β-CTX = cross-linked C-telopeptide of type I collagen BMD = bone mineral density BP = bisphosphonate DXA = dual-energy X-ray absorptiometry 25OHD = 25-hydroxyvitamin D OI = osteogenesis imperfecta PTH = parathyroid hormone.

  6. Alendronate Once Weekly for the Prevention and Treatment of Bone Loss in Canadian Adult Cystic Fibrosis Patients (CFOS Trial)

    PubMed Central

    Papaioannou, Alexandra; Kennedy, Courtney C.; Freitag, Andreas; Ioannidis, George; O’Neill, John; Webber, Colin; Pui, Margaret; Berthiaume, Yves; Rabin, Harvey R.; Paterson, Nigel; Jeanneret, Alphonse; Matouk, Elias; Villeneuve, Josee; Nixon, Madeline; Adachi, Jonathan D.

    2016-01-01

    Background Patients with cystic fibrosis (CF) are at risk for early bone loss, and demonstrate increased risks for vertebral fractures and kyphosis. A multicenter, randomized, controlled trial was conducted to assess the efficacy, tolerability, and safety of therapy with oral alendronate (FOSAMAX; Merck; Whitehouse Station, NJ) in adults with CF and low bone mass. Methods Participants received placebo or alendronate, 70 mg once weekly, for 12 months. All participants received 800 IV of vitamin D and 1,000 mg of calcium daily. Adults with confirmed CF with a bone mineral density (BMD) T score of < − 1.0 were eligible for inclusion. Participants who had undergone organ transplantation or had other reported contraindications were excluded from the study. The primary outcome measure was the mean (± SD) percentage change in lumbar spine BMD after 12 months. Secondary measures included the percentage change in total hip BMD, the number of new vertebral fractures (grade 1 or 2), and changes in quality of life. Results A total of56 participants were enrolled in the study (mean age, 29.1 ± 8.78 years; 61%male). The absolute percentage changes in lumbar spine and total hip BMDs at follow-up were significantly higher in the alendronate therapy group (5.20 ± 3.67% and 2.14 ± 3.32%, respectively) than those in the control group (− 0.08 ± 3.93% and − 1.3 ± 2.70%, respectively; p < 0.001). At follow-up, two participants (both in the control group) had a new vertebral fracture (not significant), and there were no differences in quality of life or the number of adverse events (including serious and GI-related events). Conclusion Alendronate therapy was well tolerated and produced a significantly greater increase in BMD over 12 months compared with placebo. Trial registration ClinicalTrials.gov Identifier: NCT00157690 PMID:18641106

  7. Bilateral patellar fractures and increased cortical bone thickness associated with long-term oral alendronate treatment in a cat

    PubMed Central

    Council, Nicola; Dyce, Jon; Drost, Wm Tod; de Brito Galvao, Joao Felipe; Rosol, Thomas J; Chew, Dennis J

    2017-01-01

    Case summary A 14-year-old cat presented with bilateral patellar fractures and radiographically thickened tibial cortices. This cat had been treated with alendronate for 8 years prior to presentation. To remove the subjectivity of the radiographic evaluation, tibial radiographs from 35 apparently healthy geriatric cats were used for comparison. Cortical and diaphyseal thickness were measured at the proximal and distal thirds of the tibia. Our cat had increased cortical bone thickness compared to that of the control cats. Relevance and novel information Treatment with bisphosphonates can lead to brittle bones and fractures after prolonged use in humans. This is the first description of fractures and cortical bone changes that may have been associated with prolonged bisphosphonate use in a cat. Radiographic measurements of cortical bone thickness may identify cats that are at increased risk for bone pathology secondary to prolonged alendronate use. PMID:28890795

  8. Possible alendronate-induced polyarticular synovitis.

    PubMed

    Gökkus, K; Yazicioglu, G; Sagtas, E; Uyan, A; Aydin, A T

    2016-01-01

    We present a case of polyarticular synovitis following alendronate treatment for osteoporosis. The patient had no evidence of rheumatoid arthritis, pyrophosphate arthropathy, or seronegative/seropositive arthritis. Our main aim in this study is to highlight the potential adverse effects of alendronate and to warn orthopedic surgeons about the possibility of such a side effect that might lead orthopedic surgeons to administer wrong and unnecessary treatments like arthrocentesis. The withdrawal of alendronate is found to be the treatment of choice. Alendronate should be considered as a possible cause of synovitis or polyarthritis in patients treated with this agent in the absence of any other pathology. An association between alendronate and synovitis has rarely been described in the literature. We present a patient who developed polyarticular synovitis after treatment with alendronate and responded to its withdrawal.

  9. Primary brain calcification in patients undergoing treatment with the biphosphanate alendronate.

    PubMed

    Oliveira, J R M; Oliveira, M F

    2016-03-15

    Brain calcification might be associated with various metabolic, infectious or vascular conditions. Clinically, brain calcification can include symptoms such as migraine, parkinsonism, psychosis or dementia. The term Primary Brain Calcification was recently used for those patients without an obvious cause (formerly idiopathic) while Primary Familial Brain Calcifications was left for the cases with autosomal dominant inheritance. Recent studies found mutations in four genes (SLC20A2, PDGFRB, PDGFB and XPR1). However, these gene represent only 60% of all familial cases suggesting other genes remain to be elucidated. Studies evaluating treatments for such a devastating disease are scattered, usually appearing as single case reports. In the present study, we describe a case series of 7 patients treated with Alendronate, a widely prescribed biphosphanate. We observed good tolerance and evidence of improvements and stability by some patients. No side effects were reported and no specific symptoms related to medication. Younger patients and one individual continuing a prescription (prior to study commencement) appeared to respond more positively with some referred improvements in symptoms. Biphosphanates may represent an excellent prospect for the treatment of brain calcifications due to their being well tolerated and easily available. Conversely, prospective and controlled studies should promptly address weaknesses found in the present analysis.

  10. Inhibited osteoclastic bone resorption through alendronate treatment in rats reduces severe osteoarthritis progression.

    PubMed

    Siebelt, M; Waarsing, J H; Groen, H C; Müller, C; Koelewijn, S J; de Blois, E; Verhaar, J A N; de Jong, M; Weinans, H

    2014-09-01

    Osteoarthritis (OA) is a non-rheumatoid joint disease characterized by progressive degeneration of extra-cellular cartilage matrix (ECM), enhanced subchondral bone remodeling, osteophyte formation and synovial thickening. Alendronate (ALN) is a potent inhibitor of osteoclastic bone resorption and results in reduced bone remodeling. This study investigated the effects of pre-emptive use of ALN on OA related osteoclastic subchondral bone resorption in an in vivo rat model for severe OA. Using multi-modality imaging we measured effects of ALN treatment within cartilage and synovium. Severe osteoarthritis was induced in left rat knees using papain injections in combination with a moderate running protocol. Twenty rats were treated with subcutaneous ALN injections and compared to twenty untreated controls. Animals were longitudinally monitored for 12weeks with in vivo μCT to measure subchondral bone changes and SPECT/CT to determine synovial macrophage activation using a folate-based radiotracer. Articular cartilage was analyzed at 6 and 12weeks with ex vivo contrast enhanced μCT and histology to measure sulfated-glycosaminoglycan (sGAG) content and cartilage thickness. ALN treatment successfully inhibited subchondral bone remodeling. As a result we found less subchondral plate porosity and reduced osteophytosis. ALN treatment did not reduce subchondral sclerosis. However, after the OA induction phase, ALN treatment protected cartilage ECM from degradation and reduced synovial macrophage activation. Surprisingly, ALN treatment also improved sGAG content of tibia cartilage in healthy joints. Our data was consistent with the hypothesis that osteoclastic bone resorption might play an important role in OA and may be a driving force for progression of the disease. However, our study suggest that this effect might not solely be effects on osteoclastic activity, since ALN treatment also influenced macrophage functioning. Additionally, ALN treatment and physical activity

  11. Atypical femoral fracture after long-term alendronate treatment: report of a case evidenced with magnetic resonance imaging.

    PubMed

    Kao, Chih-Ming; Huang, Peng-Ju; Chen, Chung-Hwan; Chen, Shu-Jung; Cheng, Yuh-Min

    2012-10-01

    Postmenopausal osteoporosis is commonly treated with alendronate, one of the bisphosphonates used for the prevention and treatment of osteoporotic fractures. However, the correlation between atypical femoral fractures and long-term bisphosphonate therapy has not been clearly identified. We report here the case of a 69-year-old woman with postmenopausal osteoporosis who presented with an atypical femoral subtrochanteric fracture on magnetic resonance imaging (MRI) confirmation after having received alendronate therapy for about 3 years. The fracture united after refixation and after administration of alendronate was stopped. Several published reports were reviewed, and some clinical characteristics of this atraumatic fracture were revealed, including the clinical symptoms of thigh pain, stress reaction or stress fracture, and transverse fracture with unicortical beak in an area of cortical hypertrophy. In addition to a regular radiographic survey, MRI, which may provide early information, and bone biopsy for pathologic analysis may be used as tools for early detection and final diagnosis. Once an insufficiency fracture is suspected or proved to be related to bisphosphonate, the withholding of bisphosphonate should be highly recommended to enhance fracture healing. Prophylactic fixation should be considered if fracture healing is not good or if the patient cannot tolerate protection of weight-bearing. Copyright © 2012. Published by Elsevier B.V.

  12. Alendronate treatment alters bone tissues at multiple structural levels in healthy canine cortical bone.

    PubMed

    Acevedo, Claire; Bale, Hrishikesh; Gludovatz, Bernd; Wat, Amy; Tang, Simon Y; Wang, Mingyue; Busse, Björn; Zimmermann, Elizabeth A; Schaible, Eric; Allen, Matthew R; Burr, David B; Ritchie, Robert O

    2015-12-01

    Bisphosphonates are widely used to treat osteoporosis, but have been associated with atypical femoral fractures (AFFs) in the long term, which raises a critical health problem for the aging population. Several clinical studies have suggested that the occurrence of AFFs may be related to the bisphosphonate-induced changes of bone turnover, but large discrepancies in the results of these studies indicate that the salient mechanisms responsible for any loss in fracture resistance are still unclear. Here the role of bisphosphonates is examined in terms of the potential deterioration in fracture resistance resulting from both intrinsic (plasticity) and extrinsic (shielding) toughening mechanisms, which operate over a wide range of length-scales. Specifically, we compare the mechanical properties of two groups of humeri from healthy beagles, one control group comprising eight females (oral doses of saline vehicle, 1 mL/kg/day, 3 years) and one treated group comprising nine females (oral doses of alendronate used to treat osteoporosis, 0.2mg/kg/day, 3 years). Our data demonstrate treatment-specific reorganization of bone tissue identified at multiple length-scales mainly through advanced synchrotron x-ray experiments. We confirm that bisphosphonate treatments can increase non-enzymatic collagen cross-linking at molecular scales, which critically restricts plasticity associated with fibrillar sliding, and hence intrinsic toughening, at nanoscales. We also observe changes in the intracortical architecture of treated bone at microscales, with partial filling of the Haversian canals and reduction of osteon number. We hypothesize that the reduced plasticity associated with BP treatments may induce an increase in microcrack accumulation and growth under cyclic daily loadings, and potentially increase the susceptibility of cortical bone to atypical (fatigue-like) fractures.

  13. Effects of raloxifene and alendronate on non-enzymatic collagen cross-links and bone strength in ovariectomized rabbits in sequential treatments after daily human parathyroid hormone (1-34) administration.

    PubMed

    Kimura, S; Saito, M; Kida, Y; Seki, A; Isaka, Y; Marumo, K

    2017-03-01

    This study investigated the effects of raloxifene and alendronate to follow parathyroid hormone (PTH) on bone collagen and biomechanical properties in ovariectomized rabbits. Sequential treatments of raloxifene and alendronate after hPTH(1-34) treatment improved biomechanical properties with and without bone collagen improvement, respectively.

  14. Vitamin D status and bone mineral density changes during alendronate treatment in postmenopausal osteoporosis.

    PubMed

    Roux, Christian; Binkley, Neil; Boonen, Steven; Kiel, Douglas P; Ralston, Stuart H; Reginster, Jean-Yves; Regnister, Jean-Yves; Pong, Annpey; Rosenberg, Elizabeth; Santora, Arthur

    2014-02-01

    Vitamin D supplementation is recommended for women with osteoporosis. In the FOCUS-D trial comparing the combination tablet alendronate plus vitamin D3 5,600 IU (ALN/D) with standard care (SC) prescribed by patients' personal physicians, ALN/D was more effective in improving serum 25(OH)D and bone turnover markers by 6 months and increasing spine and hip bone mineral density (BMD) after 1 year than SC. This post hoc analysis examined the relationship between BMD gain and 25(OH)D in women in SC receiving alendronate (SC/ALN, n = 134, 52% of the SC group) and in the ALN/D group (n = 257). At baseline, participants were of mean age 73 years and 72% were Caucasian, with a mean 25(OH)D of 14.9 ng/mL. In the SC/ALN group, most received vitamin D, although intake of vitamin D varied extensively (51% received <400 μg/day). In this group, end-of-study 25(OH)D correlated positively with mean percent increases from baseline in lumbar spine and femoral neck BMD [Pearson correlation coefficients (95% CI) = 0.23 (0.02-0.41) and 0.24 (0.03-0.41), respectively]. Baseline 25(OH)D correlated with increases in only lumbar spine BMD [Pearson correlation coefficient (95% CI) = 0.22 (0.01-0.40)]. No correlations between mean BMD change and 25(OH)D were seen with ALN/D. In conclusion, in postmenopausal women with osteoporosis and low 25(OH)D receiving alendronate and a wide range of vitamin D doses, the increase in lumbar spine and femoral neck BMD was positively correlated with serum 25(OH)D achieved by the end of the study and, to some extent, with 25(OH)D concentrations at baseline. The degree of success of alendronate therapy for osteoporosis may depend on the vitamin D status of patients.

  15. Surgically treated osteonecrosis and osteomyelitis of the jaw and oral cavity in patients highly adherent to alendronate treatment: a nationwide user-only cohort study including over 60,000 alendronate users.

    PubMed

    Eiken, P A; Prieto-Alhambra, D; Eastell, R; Abrahamsen, B

    2017-06-29

    Osteonecrosis of the jaw (ONJ) is rare (2.53/10,000 person-years) among alendronate users, but long-term and compliant use are associated with an increased risk of surgically treated ONJ. Risk of surgically treated ONJ is higher in patients with rheumatoid diseases and use of proton pump inhibitors. ONJ is a rare event in users of oral bisphosphonates. Our aims were to evaluate if the risk of surgically treated ONJ increases with longer or more compliant treatment with alendronate for osteoporosis and to identify risk factors for surgically treated ONJ. Open nationwide register-based cohort study containing one nested case-control study. Patients were treatment-naïve incident users of alendronate 1996-2007 in Denmark, both genders, aged 50-94 at the time of beginning treatment (N = 61,990). Participants were followed to 31 December 2013. Over a mean of 6.8 years, 107 patients received surgery for ONJ or related conditions corresponding to an incidence rate of 2.53 (95% confidence interval (CI) 2.08 to 3.05) per 10,000 patient years. Recent use was associated with an adjusted odds ratio (OR) 4.13 (95% CI 1.94 to 8.79) compared to past use. Similarly, adherent users (medication possession ratio (MPR) >50%) were at two to threefold increased risk of ONJ compared to low adherence (MPR <50%), and long-term (>5 years) use was related with higher risk (adjusted OR 2.31 (95% CI (1.14 to 4.67)) than shorter-term use. History of rheumatoid disorders and use of proton pump inhibitors were independently associated with surgically treated ONJ. Our data suggest that recent, long-term, and compliant uses of alendronate are associated with an increased risk of surgically treated ONJ. Nevertheless, the rates remain low, even in long-term adherent users. ONJ risk appears higher in patients with conditions likely to indirectly affect the oral mucosa.

  16. Effects of long-term alendronate treatment on postmenopausal osteoporosis bone material properties.

    PubMed

    Hassler, N; Gamsjaeger, S; Hofstetter, B; Brozek, W; Klaushofer, K; Paschalis, E P

    2015-01-01

    Raman microspectroscopic analysis of iliac crest from patients that were treated with alendronate (ALN) for 10 years revealed minimal, transient alterations in bone material properties confined to actively forming bone surfaces compared to patients that were on ALN for 5 years. These changes were not encountered in the bulk tissue. Alendronate (ALN) and other bisphosphonates (BPs) are the most widely prescribed therapy for postmenopausal osteoporosis. Despite their overall excellent safety record and efficacy in reducing fractures, questions have been raised regarding potential detrimental effects that may be related to prolonged bone turnover reduction, although no definite cause-effect relationship has been established to date. The purpose of the present study was to evaluate bone material properties in patients that were receiving ALN for 5 or 10 years. Raman microspectroscopic analysis was used to analyze iliac crest biopsies from postmenopausal women with osteoporosis who had been treated with ALN for 5 years and were then re-randomized to placebo (PBO, N = 14), 5 mg/day ALN (N = 10), or 10 mg/day ALN (N = 6) for another 5 years. The parameters monitored and expressed as a function of tissue age were (i) the mineral/matrix ratio (MM), (ii) the relative proteoglycan content (PG), (iii) the relative lipid content (LPD), (iv) the mineral maturity/crystallinity (MMC), and (v) the relative pyridinoline content (PYD). The obtained data indicate that 10-year ALN use results in minimal, transient bone tissue composition changes compared to use for 5 years, confined to actively forming trabecular surfaces, implying potential differences in bone matrix maturation that nevertheless did not result in differences of these values in bulk tissue. The data suggest that prolonged reduction in bone turnover during 10 years of therapy with ALN by itself is unlikely to be associated with adverse effects on bone material properties.

  17. Enhanced anti-tumor activity and safety profile of targeted nano-scaled HPMA copolymer-alendronate-TNP-470 conjugate in the treatment of bone malignances

    PubMed Central

    Segal, Ehud; Pan, Huaizhong; Benayoun, Liat; Kopečková, Pavla; Shaked, Yuval; Kopeček, Jindčrich; Satchi-Fainaro, Ronit

    2015-01-01

    Bone neoplasms, such as osteosarcoma, exhibit a propensity for systemic metastases resulting in adverse clinical outcome. Traditional treatment consisting of aggressive chemotherapy combined with surgical resection, has been the mainstay of these malignances. Therefore, bone-targeted non-toxic therapies are required. We previously conjugated the aminobisphosphonate alendronate (ALN), and the potent anti-angiogenic agent TNP-470 with N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer. HPMA copolymer-ALN-TNP-470 conjugate exhibited improved anti-angiogenic and anti-tumor activity compared with the combination of free ALN and TNP-470 when evaluated in a xenogeneic model of human osteosarcoma. The immune system has major effect on toxicology studies and on tumor progression. Therefore, in this manuscript we examined the safety and efficacy profiles of the conjugate using murine osteosarcoma syngeneic model. Toxicity and efficacy evaluation revealed superior anti-tumor activity and decreased organ-related toxicities of the conjugate compared with the combination of free ALN plus TNP-470. Finally, comparative anti-angiogenic activity and specificity studies, using surrogate biomarkers of circulating endothelial cells (CEC), highlighted the advantage of the conjugate over the free agents. The therapeutic platform described here may have clinical translational relevance for the treatment of bone-related angiogenesis-dependent malignances. PMID:21429572

  18. Glucocorticoid Steroid and Alendronate Treatment Alleviates Dystrophic Phenotype with Enhanced Functional Glycosylation of α-Dystroglycan in Mouse Model of Limb-Girdle Muscular Dystrophy with FKRPP448L Mutation.

    PubMed

    Wu, Bo; Shah, Sapana N; Lu, Peijuan; Richardson, Stephanie M; Bollinger, Lauren E; Blaeser, Anthony; Madden, Kyle L; Sun, Yubo; Luckie, Taylor M; Cox, Michael D; Sparks, Susan; Harper, Amy D; Lu, Qi Long

    2016-06-01

    Fukutin-related protein-muscular dystrophy is characterized by defects in glycosylation of α-dystroglycan with variable clinical phenotypes, most commonly as limb-girdle muscular dystrophy 2I. There is no effective therapy available. Glucocorticoid steroids have become the standard treatment for Duchenne and other muscular dystrophies with serious adverse effects, including excessive weight gain, immune suppression, and bone loss. Bisphosphonates have been used to treat Duchenne muscular dystrophy for prevention of osteoporosis. Herein, we evaluated prednisolone and alendronate for their therapeutic potential in the FKRPP448L-mutant mouse representing moderate limb-girdle muscular dystrophy 2I. Mice were treated with prednisolone, alendronate, and both in combination for up to 6 months. Prednisolone improved muscle pathology with significant reduction in muscle degeneration, but had no effect on serum creatine kinase levels and muscle strength. Alendronate treatment did not ameliorate muscle degeneration, but demonstrated a limited enhancement on muscle function test. Combined treatment of prednisolone and alendronate provided best improvement in muscle pathology with normalized fiber size distribution and significantly reduced serum creatine kinase levels, but had limited effect on muscle force generation. The use of alendronate significantly mitigated the bone loss. Prednisolone alone and in combination with alendronate enhance functionally glycosylated α-dystroglycan. These results, for the first time, demonstrate the efficacy and feasibility of this alliance treatment of the two drugs for fukutin-related protein-muscular dystrophy. Copyright © 2016 American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.

  19. Alendronate and Risedronate for the Treatment of Postmenopausal Osteoporosis: Clinical Profiles of the Once-Weekly and Once-Daily Dosing Formulations

    PubMed Central

    Emkey, Ronald

    2004-01-01

    Objective The objective of this review is to present the clinical profiles of the once-weekly and once-daily dosing formulations of alendronate and risedronate, the 2 bisphosphonates currently available in the United States for the prevention and treatment of postmenopausal osteoporosis. Data Source/Study Selection Data were obtained from a MEDLINE literature search of all English language articles published between January 1996 and April 2004 using generic names of the bisphosphonates alendronate and risedronate. Results were refined by incorporating terms such as "osteoporosis," "bone mineral density," "fracture risk," and "adverse events." Randomized, controlled trials of once-daily and once-weekly bisphosphonate therapies were selected. Also selected for review were post hoc analyses and extension studies of the original controlled trials, including more recent data from published abstracts from scientific meetings. Data Extraction Relevant portions of articles obtained from the literature search were used to summarize the efficacy and tolerability of the 2 therapies. Conclusions In prospective trials, both bisphosphonates were effective in reducing vertebral and hip fractures in women with postmenopausal osteoporosis. In the only prospective trial evaluating hip fracture risk reduction as the primary end point, risedronate was effective at reducing hip fracture vs placebo. Both alendronate and risedronate are available in once-weekly formulations that have efficacy and tolerability profiles similar to the once-daily doses. Clinicians should review all available data for both agents as well as the medical history of the patient to make the most appropriate treatment choice. PMID:15520628

  20. Mandibular Degree II Furcation Defects Treatment With Platelet-Rich Fibrin and 1% Alendronate Gel Combination: A Randomized Controlled Clinical Trial.

    PubMed

    Kanoriya, Dharmendra; Pradeep, A R; Garg, Vibhuti; Singhal, Sandeep

    2017-03-01

    Different materials have been investigated for renewal of lost supporting periodontal structures and tested for furcation defect treatment. Platelet-rich fibrin (PRF) is a pool of growth-promoting factors and cytokines that promote bone regeneration and maturation of soft tissue. Alendronate (ALN), an influential member of the bisphosphonate group, is known to enhance osteoblastogenesis and inhibit osteoclastic bone resorption, thus promoting tissue regeneration. This randomized trial was done to assess effectiveness of PRF and 1% ALN gel combination in mandibular degree II furcation defect treatment in comparison with PRF and access therapy alone. Seventy-two mandibular molar furcation defects were treated with either access therapy alone (group 1), access therapy with PRF (group 2), or access therapy with PRF and 1% ALN (group 3). Plaque index, modified sulcus bleeding index, probing depth (PD), relative vertical attachment level (RVAL) and relative horizontal attachment level (RHAL), and intrabony defect depth were recorded at baseline and 9 months postoperatively. Radiographically, defect fill, assessed in percentage, was evaluated at baseline, before surgery, and 9 months post-therapy. Group 3 showed greater PD reduction and RVAL and RHAL gain when compared with groups 1 and 2 postoperatively. Moreover, group 3 sites showed a significantly greater percentage of radiographic defect fill (56.01% ± 2.64%) when compared with group 2 (49.43% ± 3.70%) and group 1 (10.25% ± 3.66%) at 9 months. Furcation defect treatment with autologous PRF combined with 1% ALN gel results in significant therapeutic outcomes when compared with PRF and access therapy alone. Combining ALN with PRF has potential for regeneration of furcation defects without any adverse effect on healing process.

  1. Role of 1% alendronate gel as adjunct to mechanical therapy in the treatment of chronic periodontitis among smokers

    PubMed Central

    SHARMA, Anuj; RAMAN, Achala; PRADEEP, Avani Raju

    2017-01-01

    Abstract Objective Alendronate (ALN) inhibits osteoclastic bone resorption and triggers osteostimulative properties both in vivo and in vitro, as shown by increase in matrix formation. This study aimed to explore the efficacy of 1% ALN gel as local drug delivery (LDD) in adjunct to scaling and root planing (SRP) for the treatment of chronic periodontitis among smokers. Material and Methods 75 intrabony defects were treated in 46 male smokers either with 1% ALN gel or placebo gel. ALN gel was prepared by adding ALN into carbopol-distilled water mixture. Clinical parameters [modified sulcus bleeding index, plaque index, probing depth (PD), and periodontal attachment level (PAL)] were recorded at baseline, at 2 months, and at 6 months, while radiographic parameters were recorded at baseline and at 6 months. Defect fill at baseline and at 6 months was calculated on standardized radiographs by using the image analysis software. Results Mean PD reduction and mean PAL gain were found to be greater in the ALN group than in the placebo group, both at 2 and 6 months. Furthermore, a significantly greater mean percentage of bone fill was found in the ALN group (41.05±11.40%) compared to the placebo group (2.5±0.93%). Conclusions The results of this study showed 1% ALN stimulated a significant increase in PD reduction, PAL gain, and an improved bone fill compared to placebo gel in chronic periodontitis among smokers. Thus, 1% ALN, along with SRP, is effective in the treatment of chronic periodontitis in smokers. PMID:28678942

  2. 1% alendronate gel as local drug delivery in the treatment of Class II furcation defects: a randomized controlled clinical trial.

    PubMed

    Pradeep, A R; Kumari, Minal; Rao, Nishanth S; Naik, Savitha B

    2013-03-01

    Alendronate (ALN), an aminobisphosphonate, is known to stimulate the formation of osteoblast precursors to promote osteoblastogenesis. The present study aims to explore the efficacy of 1% ALN gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of Class II furcation defects in comparison with placebo gel. A total of 69 mandibular Class II furcation defects were randomized and treated with either 1% ALN gel or placebo gel. Clinical parameters were recorded at baseline, 3 months, 6 months, and 12 months, and radiographic parameters were recorded at baseline, 6 months, and 12 months. Defect fill at baseline, 6 months, and 12 months was calculated on standardized radiographs using image analysis software. Mean probing depth (PD) reduction and mean relative vertical (RVCAL) and horizontal (RHCAL) clinical attachment level gain were shown to be greater in the ALN group than the placebo group at 3, 6, and 12 months. Furthermore, a significantly greater mean percentage of bone fill was found in the ALN group (32.11% ± 6.18%, 32.66% ± 5.86%), compared with the placebo group (2.71% ± 0.61%, 1.83% ± 1.51%), at 6 and 12 months, respectively. The results of the present study show that local delivery of 1% ALN into a Class II furcation defect stimulates a significant PD reduction, RVCAL and RHCAL gains, and improved bone fill compared with placebo gel as an adjunct to SRP. ALN can provide a new direction in management of furcation defects.

  3. Alendronate is a specific, nanomolar inhibitor of farnesyl diphosphate synthase.

    PubMed

    Bergstrom, J D; Bostedor, R G; Masarachia, P J; Reszka, A A; Rodan, G

    2000-01-01

    Alendronate, a nitrogen-containing bisphosphonate, is a potent inhibitor of bone resorption used for the treatment and prevention of osteoporosis. Recent findings suggest that alendronate and other N-containing bisphosphonates inhibit the isoprenoid biosynthesis pathway and interfere with protein prenylation, as a result of reduced geranylgeranyl diphosphate levels. This study identified farnesyl disphosphate synthase as the mevalonate pathway enzyme inhibited by bisphosphonates. HPLC analysis of products from a liver cytosolic extract narrowed the potential targets for alendronate inhibition (IC(50) = 1700 nM) to isopentenyl diphosphate isomerase and farnesyl diphosphate synthase. Recombinant human farnesyl diphosphate synthase was inhibited by alendronate with an IC(50) of 460 nM (following 15 min preincubation). Alendronate did not inhibit isopentenyl diphosphate isomerase or GGPP synthase, partially purified from liver cytosol. Recombinant farnesyl diphosphate synthase was also inhibited by pamidronate (IC(50) = 500 nM) and risedronate (IC(50) = 3.9 nM), negligibly by etidronate (IC50 = 80 microM), and not at all by clodronate. In osteoclasts, alendronate inhibited the incorporation of [(3)H]mevalonolactone into proteins of 18-25 kDa and into nonsaponifiable lipids, including sterols. These findings (i) identify farnesyl diphosphate synthase as the selective target of alendronate in the mevalonate pathway, (ii) show that this enzyme is inhibited by other N-containing bisphosphonates, such as risendronate, but not by clodronate, supporting a different mechanism of action for different bisphosphonates, and (iii) document in purified osteoclasts alendronate inhibition of prenylation and sterol biosynthesis.

  4. Alendronate: an update of its use in osteoporosis.

    PubMed

    Sharpe, M; Noble, S; Spencer, C M

    2001-01-01

    Alendronate (alendronic acid) is a nitrogen-containing bisphosphonate which binds to bone surfaces and inhibits bone resorption by osteoclasts. Oral alendronate 5 or 10 mg/day produces sustained increases in bone mineral density (BMD) in postmenopausal women with or without osteoporosis, in men with primary osteoporosis and in both men and women with or without osteoporosis receiving systemic corticosteroid therapy. Histomorphometric analyses have found that alendronate does not appear to impair bone quality. Alendronate reduced the risk of radiographic vertebral fracture, clinical vertebral fracture or hip fracture by 47 to 56% in postmenopausal women who had > or = 1 existing vertebral fracture and in those with no existing vertebral fractures but who had osteoporosis. In a number of comparative trials in postmenopausal women with osteoporosis, alendronate 10 mg/day was found to be more effective at inducing sustained increases in BMD than intranasal calcitonin, and at least as effective as conjugated estrogens and raloxifene. Alendronate 70 mg administered once weekly and 35 mg twice weekly are as effective at increasing BMD as 10 mg/day in this patient group. In clinical trials, alendronate was generally well tolerated when taken as recommended. Adverse events tended to be transient and associated with the upper GI tract, most commonly including abdominal pain, nausea, dyspepsia, acid regurgitation and musculoskeletal pain. No statistically significant differences between alendronate 10 mg/day and placebo have been found in the incidence of upper GI adverse events in large clinical trials. However, postmarketing surveillance reported a low incidence of adverse events related to the oesophagus. Specific instructions aimed at reducing the risk of upper GI adverse events have been provided by the manufacturer. Alendronate is effective and generally well tolerated in the treatment of women or men with primary (including postmenopausal) or corticosteroid

  5. Systematic review and meta-analysis of the efficacy and safety of alendronate and zoledronate for the treatment of postmenopausal osteoporosis.

    PubMed

    Serrano, Ana Julissa; Begoña, Leire; Anitua, Eduardo; Cobos, Raquel; Orive, Gorka

    2013-12-01

    The aim of this meta-analysis was to evaluate the efficacy and safety of two bisphosphonates (alendronate and zoledronate) in the treatment of postmenopausal osteoporosis. The incidence of fractures was considered as primary endpoint. Only randomized trials with a follow-up period of 1 year or more were included in this systematic review and meta-analysis. We excluded studies that included patients with secondary osteoporosis especially in relation to therapy with corticosteroids or other drugs or diseases known to affect bone mineral density. Studies published as subgroup analysis, extension studies, economic evaluations, and comparisons with active control were excluded. The methodological quality of controlled clinical trials that met these inclusion criteria was evaluated. No studies were excluded from analysis due to lack of quality. The risk ratio of hip, vertebral and wrist fractures for alendronate were 0.61 [95% confidence interval (CI) 0.40-0.93], 0.54 (95% CI 0.44-0.66) and 0.65 (95% CI 0.33-1.25), respectively. Zoledronate risk ratio was 0.62 (95% CI 0.46-0.82) and 0.38 (95% CI 0.22-0.67) for hip and vertebral fractures, respectively.

  6. ESWT and alendronate sodium demonstrate equal protective effects in osteoarthritis of the knee

    NASA Astrophysics Data System (ADS)

    Wang, Ching-Jen; Chou, Wen-Yi; Hsu, Shan-Ling; Huang, Chien-Yiu; Cheng, Jai-Hong

    2016-01-01

    This study compared the effects of extracorporeal shock wave therapy (ESWT) and alendronate sodium (alendronate) in osteoarthritis (OA) of rat knees. The control group was subjected to a sham surgery and did not receive either ESWT or alendronate treatment. The OA group underwent anterior cruciate ligament transection (ACLT) and medial meniscectomy (MM) surgery and did not receive either ESWT or alendronate. The ESWT group underwent ACLT and MM surgery and received ESWT after the surgery. The alendronate group received alendronate after ACLT and MM surgery. The evaluations included radiograph, bone mineral density (BMD), serum C-telopeptide collagen II (CTX-II), cartilage oligomeric protein (COMP), alkaline phosphatase and osteocalcin, histopathological examination and immunohistochemical analysis. Radiographs at 12 weeks showed pronounced OA changes in the OA group. The BMD values, CTX-II, COMP, alkaline phosphatase and osteocalcin showed no significant difference between ESWT and alendronate groups. In histopathology, the Mankin and Safranin O scores significantly increased in the OA, ESWT and alendronate groups, but without any significant difference between the ESWT and alendronate groups. In immunohistochemical analysis, the von Willebrand factor (vWF), vascular endothelial factor (VEGF), soluble vascular cell adhesion molecule (sVCAM), proliferating cell nuclear antigen (PCNA), bone morphogenetic protein 2 (BMP-2), and osteocalcin expressions in articular cartilage and subchondral bone showed a significant decrease in the OA group, but no difference was noted between the ESWT and alendronate groups. In conclusion, ESWT and alendronate sodium demonstrate equal protective effects from developing osteoarthritis of the knee in rats.

  7. Clinical efficacy of oral alendronate in ankylosing spondylitis: a randomised placebo-controlled trial.

    PubMed

    Coates, Lucy; Packham, Jonathan C; Creamer, Paul; Hailwood, Sarah; Bhalla, Ashley S; Chakravarty, Kuntal; Mulherin, Diamuid; Taylor, Gordon; Mattey, Derek L; Bhalla, Ashok K

    2017-01-01

    A prospective, double blind, randomised, placebo controlled trial over 2 years was performed to test the efficacy of alendronate, an oral aminobisphosphonate, in improving symptoms and arrest disease progression in patients with mild to severe ankylosing spondylitis (AS). 180 patients with AS were randomised to receive weekly alendronate 70 mg or placebo (1:1 randomisation). BAS-G was the primary outcome measure with Bath indices as secondary outcomes. Vertebral x-rays were performed at 0 and 24 months. Biomarkers (including CRP, IL-1beta, IL6, VEGF, MMP-1, and MMP-3) were collected during the first 12 months. There was no significant difference between the placebo and treatment groups in any of the recorded outcomes over the 2 years including clinical indices, biomarkers, and radiology. The change in BAS-G, the primary outcome measure, was -0.21 for the treatment group and -0.42 for the placebo group p=0.57. Change in all other clinical outcome measures were also non-significant; BASDAI p=0.86, BASFI p=0.37, BASMI p=0.021. Sub-group analysis of those subjects with a baseline BASDAI >4 were also non-significant. This prospective study demonstrates that alendronate 70mg weekly for 2 years was no more efficacious than placebo in improving clinical or laboratory measures of disease activity or measures of physical impact in subjects with mild to severe active AS. ID SRCTN12308164, registered on 15.12.2015.

  8. Alendronate prevents glucocorticoid-induced osteoporosis in patients with rheumatic diseases: A meta-analysis.

    PubMed

    Kan, Shun-Li; Yuan, Zhi-Fang; Li, Yan; Ai, Jie; Xu, Hong; Sun, Jing-Cheng; Feng, Shi-Qing

    2016-06-01

    Glucocorticoid-induced osteoporosis (GIOP) is a serious problem for patients with rheumatic diseases requiring long-term glucocorticoid treatment. Alendronate, a bisphosphonate, has been recommended in the prevention of GIOP. However, the efficacy and safety of alendronate in preventing GIOP remains controversial. We performed a meta-analysis to investigate the efficacy and safety of alendronate in preventing GIOP in patients with rheumatic diseases.We retrieved randomized controlled trials from PubMed, EMBASE, and the Cochrane Library. Two reviewers extracted the data and evaluated the risk of bias and quality of the evidence. We calculated the risk ratio (RR) with a 95% confidence interval (CI) for dichotomous outcomes, and the mean difference (MD) with a 95% CI for continuous outcomes using Review Manager, version 5.3.A total of 339 studies were found, and 9 studies (1134 patients) were included. Alendronate was not able to reduce the incidence of vertebral fractures (RR = 0.63, 95% CI: 0.10-4.04, P = 0.62) and nonvertebral fractures (RR = 0.40, 95% CI: 0.15-1.12, P = 0.08). Alendronate significantly increased the percent change in bone mineral density (BMD) at the lumbar spine (MD = 3.66, 95% CI: 2.58-4.74, P < 0.05), total hip (MD = 2.08, 95% CI: 0.41-3.74, P < 0.05), and trochanter (MD = 1.68, 95% CI: 0.75-2.61, P < 0.05). Significant differences were not observed in the percent change in BMD at the femoral neck (MD = -0.33, 95% CI: -2.79 to 2.13, P = 0.79) and total body (MD = 0.64, 95% CI: -0.06 to 1.34, P = 0.07). No significant differences in the adverse events were observed in patients treated with alendronate versus the controls (RR = 1.00, 95% CI: 0.94-1.07, P = 0.89). The odds of gastrointestinal adverse events were significantly reduced (RR = 0.77, 95% CI: 0.62-0.97, P < 0.05).Our analysis suggests that alendronate can increase the percent change in BMD at the lumbar spine, total hip, and

  9. [Pharmacological and clinical properties of alendronate sodium hydrate].

    PubMed

    Ohta, Tomohiro; Komatsu, Shozo; Tokutake, Noboru

    2002-12-01

    Alendronate (alendronate sodium hydrate; Bonalon Tablet, 5 mg) is a nitrogen-containing bisphosphonate, which combines with the bone surface and reduces osteoclast-mediated bone resorption. It is a third-generation bisphosphonate compound, specifically distributed on the surface of bone resorption and taken into osteoclasts. Under the closed circumstances which is formed with osteoclast and the bone surface, alendronate becomes detached from the bone surface and taken into osteoclast since acid released from osteoclast leads to pH decrease (acidified). The uptaken alendronate blocks the pathway of mevalonic acid synthesis, which is cholesteric synthesis, inhibits the prenylation of GTP binding protein, and decreases the osteoclast's function by influencing the cytoskeleton. This restraint of alendronate in bone resorption against osteoclasts is reversible, showing no cytotoxicity at more than hundredfold concentration level at which action occurs. Alendronate is an agent for the treatment of osteoporosis that has established safety with regards to bone quality since it neither inhibits bone calcification nor influences fracture healing in chronic administration. The most serious morbidity in osteoporosis is developing fractures. The efficacy of alendronate on restraining fracture, as well as on increase in BMD, is evidenced in Japan. Recently, in addition to senile or postmenopausal osteoporosis, drug-induced osteoporosis, such as steroid-induced osteoporosis, has attracted attention. In this regard, alendronate has been found to be an effective agent for the treatment of osteoporosis overseas, being approved in over 90 countries and used by more than 4.5 million patients. This review will give an outline of alendronate, the preparation to have introduced a concept of Evidence Based Medicine earlier, from pharmacodynamic action to clinical efficacy.

  10. Alendronate enhances osseous healing in a rat calvarial defect model.

    PubMed

    Toker, Hulya; Ozdemir, Hakan; Ozer, Hatice; Eren, Kaya

    2012-11-01

    The aim of this study was to evaluate the effect of alendronate on osseous wound healing in an experimental model. Critical size defects were created in calvaria of 40 male Wistar rats. The animals were divided into four groups of 10 animals each: autogenous bone graft group; autogenous bone graft with systemic alendronate group (0.01 mg/kg body weight per day for 8 weeks); autogenous bone graft with local alendronate group (1mg/mL for 5 min); non-treatment (control) group. Animals were sacrificed after 8 weeks; osteoblast number, lamellar bone formation, and area of newly formed bone were analysed. The osteoblast number significantly increased in the autogenous bone graft with local alendronate group compared to the autogenous bone graft group (p<0.05). Both systemic and local application of the alendronate significantly increased the new bone formation compared to the autogenous bone graft group (p<0.05) with no significant difference between local or systemic use (p>0.05). Local alendronate and autogenous bone graft use significantly increased the total bone area compared to autogenous bone graft alone (p<0.05). Alendronate enhances the new bone formation by autogenous bone graft in the rat calvarial defect model suggesting that the inhibition of the osteoclastic activity allows an increased rate of bone apposition, which could be applicable to the inflammation-induced destruction of the periodontal tissues during disease. Copyright © 2012 Elsevier Ltd. All rights reserved.

  11. Alendronate improves QOL of postmenopausal women with osteoporosis

    PubMed Central

    Kawate, Hisaya; Ohnaka, Keizo; Adachi, Masahiro; Kono, Suminori; Ikematsu, Hideyuki; Matsuo, Hisashi; Higuchi, Kazumi; Takayama, Takehiko; Takayanagi, Ryoichi

    2010-01-01

    Purpose: Postmenopausal osteoporosis causes bone fracture as well as pain, physical, psychological and socially adverse effects, which affects a patient’s quality of life (QOL). The effect of alendronate on QOL was investigated compared with that of alfacalcidol in post-menopausal osteoporotic women. Patients and methods: A total of 44 postmenopausal osteoporotic women (mean age 69.8 years) with back or joint pain, although capable of walking, were randomly assigned to two groups; group A (n = 25) received 5 mg/day of alendronate, and group B (n = 19) received 0.5 μg/day of alfacalcidol, for the first 4 months. For the following 2 months, the group A received 0.5 μg/day of alfacalcidol and the group B received 5 mg/day of alendronate in a crossover design. The patient’s QOL was evaluated by score of Japanese Osteoporosis Quality of Life Questionnaire (JOQOL), and pain intensity using a visual analog scale (VAS). Bone metabolism was measured by bone mineral density (BMD) and a biomarker for bone resorption, urinary crosslinked N-terminal telopeptide of type I collagen (NTX). Results: With 4-month treatment, alendronate, but not alfacalcidol, improved pain-related QOL, reduced joint pain by VAS, and increased bone mineral density. Both treatments significantly reduced bone resorption, the inhibition was significantly higher with alendronate (−56.5%) compared with alfacalcidol (−18.1%). After crossover, the patients in group A received alfacalcidol and had a reduced total and daily living activity-related QOL scores, and increased upper back pain by VAS. The group B received alendronate had significantly reduced bone resorption after the 2 months. Conclusion: Alendronate improves the QOL of Japanese postmenopausal women with osteoporosis by reducing pain intensity as well as increasing bone mineral density. PMID:20458350

  12. Outcomes in Alcoholism Treatment.

    ERIC Educational Resources Information Center

    Stambul, Harriet B.; Armor, David J.

    Alcoholism researchers in the past 35 years have emphasized abstinence as the major criterion of treatment success. In recent years, however, this emphasis has been questioned and from the current debate over treatment goals and outcome measures at least two areas of controversy have emerged. The first, called the "abstention-moderation"…

  13. Weekly oral alendronate in mevalonate kinase deficiency

    PubMed Central

    2013-01-01

    Background Mevalonate kinase deficiency (MKD) is caused by mutations in the MVK gene, encoding the second enzyme of mevalonate pathway, which results in subsequent shortage of downstream compounds, and starts in childhood with febrile attacks, skin, joint, and gastrointestinal symptoms, sometimes induced by vaccinations. Methods For a history of early-onset corticosteroid-induced reduction of bone mineral density in a 14-year-old boy with MKD, who also had presented three bone fractures, we administered weekly oral alendronate, a drug widely used in the management of osteoporosis and other high bone turnover diseases, which blocks mevalonate and halts the prenylation process. Results All of the patient’s MKD clinical and laboratory abnormalities were resolved after starting alendronate treatment. Conclusions This observation appears enigmatic, since alendronate should reinforce the metabolic block characterizing MKD, but is crucial because of the ultimate improvement shown by this patient. The anti-inflammatory properties of bisphosphonates are a new question for debate among physicians across various specialties, and requires further biochemical and clinical investigation. PMID:24360083

  14. Effect of Sequential Treatments with Alendronate, Parathyroid Hormone (1-34) and Raloxifene on Cortical Bone Mass and Strength in Ovariectomized Rats

    PubMed Central

    Amugongo, Sarah K.; Yao, Wei; Jia, Junjing; Dai, Weiwei; Lay, Yu-An E.; Jiang, Li; Harvey, Danielle; Zimmermann, Elizabeth A.; Schaible, Eric; Dave, Neil; Ritchie, Robert O.; Kimmel, Donald B.; Lane, Nancy E.

    2014-01-01

    Anti-resorptive and anabolic agents are often prescribed for the treatment of osteoporosis continuously or sequentially for many years. However their impact on cortical bone quality and bone strength is not clear. Methods Six-month old female rats were either sham operated or ovariectomized (OVX). OVX rats were left untreated for two months and then were treated with vehicle (Veh), hPTH (1-34) (PTH), alendronate (Aln), or raloxifene (Ral) sequentially for three month intervals, for a total of three periods. Mid-tibial cortical bone architecture, mass, mineralization, and strength were measured on necropsy samples obtained after each period. Bone indentation properties were measured on proximal femur necropsy samples. Results Eight or more months of estrogen deficiency in rats resulted in decreased cortical bone area and thickness. Treatment with PTH for 3 months caused the deposition of endocortical lamellar bone that increased cortical bone area, thickness, and strength. These improvements were lost when PTH was withdrawn without followup treatment, but were maintained for the maximum times tested, six months with Ral and three months with Aln. Pre-treatment with anti-resorptives was also somewhat successful in ultimately preserving the additional endocortical lamellar bone formed under PTH treatment. These treatments did not affect bone indentation properties. Summary Sequential therapy that involved both PTH and anti-resorptive agents was required to achieve lasting improvements in cortical area, thickness, and strength in OVX rats. Anti-resorptive therapy, either prior to or following PTH, was required to preserve gains attributable to an anabolic agent. PMID:25016965

  15. Efficient Transdermal Delivery of Alendronate, a Nitrogen-Containing Bisphosphonate, Using Tip-Loaded Self-Dissolving Microneedle Arrays for the Treatment of Osteoporosis.

    PubMed

    Katsumi, Hidemasa; Tanaka, Yutaro; Hitomi, Kaori; Liu, Shu; Quan, Ying-Shu; Kamiyama, Fumio; Sakane, Toshiyasu; Yamamoto, Akira

    2017-08-17

    To improve the transdermal bioavailability and safety of alendronate (ALN), a nitrogen-containing bisphosphonate, we developed self-dissolving microneedle arrays (MNs), in which ALN is loaded only at the tip portion of micron-scale needles by a dip-coating method (ALN(TIP)-MN). We observed micron-scale pores in rat skin just after application of ALN(TIP)-MN, indicating that transdermal pathways for ALN were created by MN. ALN was rapidly released from the tip of MNs as observed in an in vitro release study. The tip portions of MNs completely dissolved in the rat skin within 5 min after application in vivo. After application of ALN(TIP)-MN in mice, the plasma concentration of ALN rapidly increased, and the bioavailability of ALN was approximately 96%. In addition, the decrease in growth plate was effectively suppressed by this efficient delivery of ALN in a rat model of osteoporosis. Furthermore, no skin irritation was observed after application of ALN(TIP)-MN and subcutaneous injection of ALN, while mild skin irritation was induced by whole-ALN-loaded MN (ALN-MN)-in which ALN is contained in the whole of the micron-scale needles fabricated from hyaluronic acid-and intradermal injection of ALN. These findings indicate that ALN(TIP)-MN is a promising transdermal formulation for the treatment of osteoporosis without skin irritation.

  16. The effects of 2-year treatment with the aminobisphosphonate alendronate on bone metabolism, bone histomorphometry, and bone strength in ovariectomized nonhuman primates.

    PubMed Central

    Balena, R; Toolan, B C; Shea, M; Markatos, A; Myers, E R; Lee, S C; Opas, E E; Seedor, J G; Klein, H; Frankenfield, D

    1993-01-01

    This study examined the effect of 2 yr of treatment with the aminobisphosphonate alendronate (ALN) (0.05 or 0.25 mg/kg i.v. ALN every 2 wk) on estrogen deficiency bone loss and bone strength changes in ovariectomized (OVX) baboons (n = 7 per group) and the ALN mode of action at the tissue level. Biochemical markers of bone turnover increased in OVX animals and were maintained by ALN treatment at non-OVX levels (low dose) or below (high dose). 2 yr of treatment produced no cumulative effects on bone turnover markers. Histomorphometry showed a marked increase in cancellous bone remodeling in OVX animals. Activation frequency increased from 0.48 to 0.86 per yr (L5 vertebra), and the osteoid surfaces from 9 to 13.5% (P < 0.05). No changes were observed in eroded and osteoclast surfaces. ALN treatment decreased activation frequency and indices of bone formation to control levels (low dose) or below (high dose), did not change indices of mineralization, and increased bone mineral density (BMD) in the lumbar vertebrae (L2-L4) by 15% at 0.25 mg/kg (P < 0.05), relative to vehicle-treated animals. The mean strength of cancellous bone (L4) increased by 44% (low ALN dose) and 100% (high dose), compared with vehicle. The strength of individual bones correlated with the square of the L2-L4 BMD (r = 0.91, P < 0.0034). In conclusion, ALN treatment reversed the effects of ovariectomy on cancellous bone turnover and increased bone mass and bone strength in baboons. PMID:8254015

  17. Genetic polymorphisms in the mevalonate pathway affect the therapeutic response to alendronate treatment in postmenopausal Chinese women with low bone mineral density.

    PubMed

    Wang, C; Zheng, H; He, J-W; Zhang, H; Yue, H; Hu, W-W; Gu, J-M; Shao, C; Fu, W-Z; Hu, Y-Q; Li, M; Liu, Y-J; Zhang, Z-L

    2015-04-01

    Alendronate is an antiosteoporotic drug that targets the mevalonate pathway. To investigate whether the genetic variations in this pathway affect the clinical efficacy of alendronate in postmenopausal Chinese women with osteopenia or osteoporosis, 23 single-nucleotide polymorphisms (SNPs) in 7 genes were genotyped in 500 patients treated with alendronate for 12 months. Bone mineral density (BMD) was measured at baseline and after 12 months. The rs10161126 SNP in the 3' flanking region of MVK and the GTCCA haplotype in FDFT1 were significantly associated with therapeutic response. A 6.6% increase in BMD in the lumbar spine was observed in the GG homozygotes of rs10161126; AG heterozygotes and AA homozygotes experienced a 4.4 and 4.5% increase, respectively. The odds ratio (95% confidence interval) of G allele carriers to be responders in lumbar spine BMD was 2.06 (1.08-6.41). GTCCA haplotype in FDFT1 was more frequently detected in the group of responders than in the group of non-responders at the total hip (2.6 vs 0.5%, P=0.009). Therefore, MVK and FDFT1 polymorphisms are genetic determinants for BMD response to alendronate therapy in postmenopausal Chinese women.

  18. Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate.

    PubMed

    Kendler, D L; McClung, M R; Freemantle, N; Lillestol, M; Moffett, A H; Borenstein, J; Satram-Hoang, S; Yang, Y-C; Kaur, P; Macarios, D; Siddhanti, S

    2011-06-01

    In this study, 250 women with osteoporosis were randomized to 12 months with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly, then crossed over to the other treatment. The primary endpoint, treatment adherence at 12 months, was 76.6% for alendronate and 87.3% for denosumab. The purpose of this study is to evaluate treatment adherence with subcutaneous denosumab 60 mg every 6 months or oral alendronate 70 mg once weekly. In this multicenter, randomized, open-label, 2-year, crossover study, 250 postmenopausal women with low bone mineral density received denosumab or alendronate for 12 months, then the other treatment for 12 months. The alendronate bottle had a medication event monitoring system cap to monitor administration dates. Definitions were as follows: compliance, receiving both denosumab doses 6 (± 1) months apart or 80-100% of alendronate doses; persistence, receiving both denosumab doses and completing the month 12 visit within the visit window or ≥ 2 alendronate doses in the final month; adherence, achieving both compliance and persistence. This report includes data from the first 12 months. The primary study endpoint, adherence in the first 12 months, was 76.6% (95/124) for alendronate and 87.3% (110/126) for denosumab. Risk ratios for denosumab compared with alendronate at 12 months were 0.58 (p = 0.043) for non-adherence, 0.48 (p = 0.014) for non-compliance, and 0.54 (p = 0.049) for non-persistence. Subject ratings for treatment necessity, preference, and satisfaction were significantly greater for denosumab and ratings for treatment bother were significantly greater for alendronate. Adverse events were reported by 64.1% of alendronate-treated subjects and 72.0% of denosumab-treated subjects (p = 0.403). The most common adverse events were arthralgia, back pain, pain in extremity, cough, and headache (each in <10% of subjects in each group). Significantly greater treatment adherence was observed for subcutaneous

  19. Alendronate improves screw fixation in osteoporotic bone.

    PubMed

    Moroni, Antonio; Faldini, Cesare; Hoang-Kim, Amy; Pegreffi, Francesco; Giannini, Sandro

    2007-01-01

    Animal studies have demonstrated the efficacy of the use of bisphosphonates to enhance screw fixation in bone. In this prospective, randomized study of pertrochanteric fractures treated with external fixation, we tested whether systemic administration of bisphosphonates would improve the fixation of hydroxyapatite-coated screws implanted in osteoporotic bone. Sixteen consecutive patients with a pertrochanteric fracture were selected. Inclusion criteria were female gender, an age of at least sixty-five years, and a bone mineral density T-score of less than -2.5 standard deviations. Exclusion criteria included bisphosphonate treatment during the two-year period prior to the fracture. Fractures were fixed with a pertrochanteric fixator and four hydroxyapatite-coated pins. Two pins were implanted in the femoral head (pin positions 1 and 2), and two were placed in the femoral diaphysis (pin positions 3 and 4). The patients were randomized either to therapy with alendronate for a three-month postoperative period (Group A) or to no therapy (Group B). The Group-A patients received an oral dose of 70 mg of alendronate per week. The fixators were removed after three months. All of the fractures healed, and no loss of reduction, nonunion, or delayed union was observed. The combined mean extraction torque (and standard deviation) of the pins implanted at positions 1 and 2 (cancellous bone) was 2558 +/- 1103 N/mm in Group A and 1171 +/- 480 N/mm in Group B (p < 0.0005). The combined mean extraction torque of the pins implanted at positions 3 and 4 (cortical bone) was 4327 +/- 1720 N/mm in Group A and 4075 +/- 1022 N/mm in Group B. These data show that weekly systemic administration of alendronate improves pin fixation in cancellous bone in elderly female patients with osteoporosis. We observed a twofold increase in extraction torque with the pins implanted in cancellous bone. These results support the use of alendronate in the treatment of osteoporotic pertrochanteric fractures

  20. Oral Alendronate Treatment for Severe Polyostotic Fibrous Dysplasia due to McCune-Albright Syndrome in a Child: A Case Report

    PubMed Central

    2010-01-01

    Polyostotic fibrous dysplasia (FD) associated to McCune-Albright Syndrome (MAS) often leads to fractures, deformities, and bone pain resulting in bad quality of life. Parenteral bisphosphonates have been used in children and adolescents to improve these symptoms with few adverse effects. We evaluated the response to oral Alendronate in a girl with severe MAS FD and observed improved quality of life with reduction of bone pain. PMID:20976302

  1. Alendronate. A review of its pharmacological properties and therapeutic efficacy in postmenopausal osteoporosis.

    PubMed

    Jeal, W; Barradell, L B; McTavish, D

    1997-03-01

    treatment of choice for the management of postmenopausal osteoporosis, many women are unable or unwilling to receive estrogens on a long term basis. Thus, alendronate, with its demonstrated beneficial effects and its good tolerability profile (when taken as recommended), is a promising alternative treatment option for the management of postmenopausal osteoporosis.

  2. Risk of hip, subtrochanteric, and femoral shaft fractures among mid and long term users of alendronate: nationwide cohort and nested case-control study

    PubMed Central

    Abrahamsen, Bo; Eiken, Pia; Eastell, Richard

    2016-01-01

    Objectives To determine the skeletal safety and efficacy of long term (≥10 years) alendronate use in patients with osteoporosis. Design Open register based cohort study containing two nested case control studies. Setting Nationwide study of population of Denmark. Participants 61 990 men and women aged 50-94 at the start of treatment, who had not previously taken alendronate, 1996-2007. Interventions Treatment with alendronate. Main outcome measures Incident fracture of the subtrochanteric femur or femoral shaft (ST/FS) or the hip. Non-fracture controls from the cohort were matched to fracture cases by sex, year of birth, and year of initiation of alendronate treatment. Conditional logistic regression models were fitted to calculate odds ratios with and without adjustment for comorbidity and comedications. Sensitivity analyses investigated subsequent treatment with other drugs for osteoporosis. Results 1428 participants sustained a ST/FS (incidence rate 3.4/1000 person years, 95% confidence interval 3.2 to 3.6), and 6784 sustained a hip fracture (16.2/1000 person years, 15.8 to 16.6). The risk of ST/FS was lower with high adherence to treatment with alendronate (medication possession ratio (MPR, a proxy for compliance) >80%) compared with poor adherence (MPR <50%; odds ratio 0.88, 0.77 to 0.99; P=0.05). Multivariable adjustment attenuated this association (adjusted odds ratio 0.88, 0.77 to 1.01; P=0.08). The risk was no higher in long term users (≥10 dose years; 0.70, 0.44 to 1.11; P=0.13) or in current compared with past users (0.91, 0.79 to 1.06; P=0.22). Similarly, MPR >80% was associated with a decreased risk of hip fracture (0.73, 0.68 to 0.78; P<0.001) as was longer term cumulative use for 5-10 dose years (0.74, 0.67 to 0.83; P<0.001) or ≥10 dose years (0.74, 0.56 to 0.97; P=0.03). Conclusions These findings support an acceptable balance between benefit and risk with treatment with alendronate in terms of fracture outcomes, even for over 10

  3. Development of a novel self-dissolving microneedle array of alendronate, a nitrogen-containing bisphosphonate: evaluation of transdermal absorption, safety, and pharmacological effects after application in rats.

    PubMed

    Katsumi, Hidemasa; Liu, Shu; Tanaka, Yutaro; Hitomi, Kaori; Hayashi, Rie; Hirai, Yuka; Kusamori, Kosuke; Quan, Ying-shu; Kamiyama, Fumio; Sakane, Toshiyasu; Yamamoto, Akira

    2012-09-01

    Alendronate is a nitrogen-containing bisphosphonate that is widely used for the treatment of osteoporosis. In this study, we developed a novel self-dissolving micron-size needle array (microneedle array) containing alendronate, which was fabricated by micromodeling technologies using hyaluronic acid as a basic material. Micron-scale pores in the skin were seen after the application of the alendronate-loaded microneedle array, verifying establishment of transdermal pathways for alendronate. The absorption of alendronate after the application of alendronate-loaded microneedle array was almost equivalent to that after subcutaneous administration, and the bioavailability of alendronate was approximately 90% in rats. Furthermore, delivery of alendronate via this strategy effectively suppressed the decrease in the width of the growth plate in a rat model of osteoporosis. Although mild cutaneous irritation was observed after the application of the alendronate-loaded microneedle array, it resolved by day 15. These findings indicate that this alendronate-loaded microneedle array is a promising transdermal formulation for the treatment of osteoporosis.

  4. Fractures in women treated with raloxifene or alendronate: a retrospective database analysis

    PubMed Central

    2013-01-01

    Background Raloxifene and alendronate are anti-resorptive therapies approved for the prevention and treatment of postmenopausal osteoporosis. Raloxifene is also indicated to reduce the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk of invasive breast cancer. A definitive study comparing the fracture effectiveness and rate of breast cancer for raloxifene and alendronate has not been published. The purpose of this retrospective cohort study was to evaluate fracture and breast cancer rates among patients treated with raloxifene or alendronate. Methods Females ≥45 years who initiated raloxifene or alendronate in 1998–2006 Truven Health Analytics MarketScan® Databases, had continuous enrollment 12 months prior to and at least 12 months after the index date, and had a treatment medication possession ratio ≥80% were included in this study. Rates of vertebral and nonvertebral fractures and breast cancer during 1, 3, 5, 6, 7, and 8 years of treatment with raloxifene or alendronate were evaluated. Fracture rates were adjusted for potential treatment bias using inverse probability of treatment weights. Multivariate hazard ratios were estimated for vertebral and nonvertebral fractures. Results Raloxifene patients had statistically significantly lower rates of vertebral fractures in 1, 3, 5, and 7 years and for nonvertebral fractures in 1 and 5 years. There were no statistically significant differences in the adjusted fracture rates between raloxifene and alendronate cohorts, except in the 3-year nonvertebral fracture rates where raloxifene was higher. Multivariate hazard ratios of raloxifene versus alendronate cohorts were not significantly different for vertebral and nonvertebral fracture in 1, 3, 5, 6, 7, and 8 years. Unweighted and weighted breast cancer rates were lower among raloxifene recipients. Conclusions Patients treated with alendronate and raloxifene had similar adjusted

  5. Severely suppressed bone turnover: a potential complication of alendronate therapy.

    PubMed

    Odvina, Clarita V; Zerwekh, Joseph E; Rao, D Sudhaker; Maalouf, Naim; Gottschalk, Frank A; Pak, Charles Y C

    2005-03-01

    Alendronate, an inhibitor of bone resorption, is widely used in osteoporosis treatment. However, concerns have been raised about potential oversuppression of bone turnover during long-term use. We report on nine patients who sustained spontaneous nonspinal fractures while on alendronate therapy, six of whom displayed either delayed or absent fracture healing for 3 months to 2 yr during therapy. Histomorphometric analysis of the cancellous bone showed markedly suppressed bone formation, with reduced or absent osteoblastic surface in most patients. Osteoclastic surface was low or low-normal in eight patients, and eroded surface was decreased in four. Matrix synthesis was markedly diminished, with absence of double-tetracycline label and absent or reduced single-tetracycline label in all patients. The same trend was seen in the intracortical and endocortical surfaces. Our findings raise the possibility that severe suppression of bone turnover may develop during long-term alendronate therapy, resulting in increased susceptibility to, and delayed healing of, nonspinal fractures. Although coadministration of estrogen or glucocorticoids appears to be a predisposing factor, this apparent complication can also occur with monotherapy. Our observations emphasize the need for increased awareness and monitoring for the potential development of excessive suppression of bone turnover during long-term alendronate therapy.

  6. In vitro determination of the release of alendronic acid from alendronate tablets of different brands during deglutition.

    PubMed

    Lamprecht, Guenther

    2009-10-01

    Alendronic acid, a frequently applied compound for the treatment of different forms of diseases of bone metabolism, is a strong acid with a high solubility in water. In connection with the oral administration this exhibits a potential health risk for the upper gastrointestinal tract. The in vitro release of tablets containing alendronic acid of different brands (Stada, ratiopharm, interpharm, Fosamax) was determined by dissolution tests for the time period required for oral intake. The effect of rotation speed, temperature, and solvent volume on the release rate of alendronic acid was determined for the used dissolution apparatus. Analysis of alendronic acid was performed by a validated HPLC method. The highest rate of release was found for the original brand. The dissolution rate of the generic formulations was significantly lower in the early stage of dissolution. Over the complete range of dissolution, more than 85% of the claimed amount was dissolved within 4 min. Dissolution profiles were compared by calculation of the similarity factor f(2) showing equal products with the exception of one generic product, whose dissolution rate was lower.

  7. Analysis of bone metabolism during early stage and clinical benefits of early intervention with alendronate in patients with systemic rheumatic diseases treated with high-dose glucocorticoid: Early DIagnosis and Treatment of OsteopoRosis in Japan (EDITOR-J) study.

    PubMed

    Tanaka, Yoshiya; Mori, Hiroko; Aoki, Takatoshi; Atsumi, Tatsuya; Kawahito, Yutaka; Nakayama, Hisanori; Tohma, Shigeto; Yamanishi, Yuji; Hasegawa, Hitoshi; Tanimura, Kazuhide; Negoro, Nobuo; Ueki, Yukitaka; Kawakami, Atsushi; Eguchi, Katsumi; Saito, Kazuyoshi; Okada, Yosuke

    2016-11-01

    We conducted a prospective multicenter study to assess early changes in the dynamics of bone metabolism in patients with systemic connective tissue diseases following commencement of high-dose glucocorticoid therapy and the benefits of early treatment with bisphosphonate and vitamin D analogue. The subjects of this randomized controlled trial were 106 female patients with systemic connective tissue diseases treated for the first time with glucocorticoids at doses equivalent to prednisolone ≥20 mg/day (age ≥ 18 years). One week after initiation of glucocorticoid therapy, patients were randomly assigned to treatment with alfacalcidol at 1 μg/day (n = 33), alendronate 35 mg/week (n = 37), and alfacalcidol plus alendronate (n = 36). The primary endpoints were changes in lumbar spine bone density at 6 months of treatment and the frequency of bone fracture at 12 months. Commencement of glucocorticoid therapy was associated with a rapid and marked bone resorption within 1 week. The combination of alfacalcidol and alendronate administered after the first week of glucocorticoid therapy halted the pathological processes affecting bone metabolism, increased bone density, and reduced the incidence of bone fracture over a period of 12 months. Taken together, the use of the combination of alfacalcidol and alendronate improved bone metabolism, increased bone density, and significantly reduced the incidence of bone fracture during 1-year high-dose glucocorticoid therapy.

  8. Parathyroid hormone plus alendronate in osteoporosis: a meta-analysis of randomized controlled trials

    PubMed Central

    Zhang, Qinggang; Qian, Jing; Zhu, Yuchang

    2015-01-01

    Background: Parathyroid hormone (PTH) increases both bone formation (BMD) and bone resorption, whereas alendronate reduces bone resorption. It is possible that the combination therapy of PTH with alendronate will enhance their effects on BMD. Therefore, we conducted this meta-analysis to evaluate the efficacy of the combination therapy of PTH with alendronate in the treatment of patients with osteoporosis. Methods: A comprehensive literature search of PubMed, Embase, and Web of Science was conducted to identify relative studies. Eligible studies were randomized controlled trials (RCT), which assessed the efficacy of combination therapy in patients with osteoporosis. The outcomes included the mean percent increases in BMD of lumbar spine, femoral neck, total hip, and distal radius. Weighted mean difference (WMD) with 95% confidence intervals (CIs) were calculated using of random-effects or fixed-effects model, depending on the heterogeneity between the included studies. Results: Six RCTs with a total number of 833 patients were included in this meta-analysis. The pooled estimates showed that, the combination therapy of PTH with alendronate resulted in a higher mean percent change of increased BMD in distal radius (WMD = 2.45, 95% CI: 1.58, 3.31; P = 0.000), but not in lumbar spine (WMD = -0.83, 95% CI: -3.48, 1.81; P = 0.538), femoral neck (WMD = -0.99, 95% CI: -2.04, 0.07; P = 0.068), and total hip (WMD = -0.06, 95% CI: -0.93, 0.81; P = 0.892). The subgroup analysis based on the dosage and schedule of PTH, study duration, gender of patients, and anabolic agents, were conducted. And results revealed that among the patients in the combination therapy group, greater increases in the spine BMD were observed when the PTH was administered with a dosage of 20 μg (WMD = 2.33, 95% CI: 1.24, 3.43; P = 0.000), or the treatment duration lasted more than 12 months (WMD = 2.23, 95% CI: 1.00, 3.47; P = 0.000), or the combination therapy was used in osteoporosis women (WMD = 1

  9. Alendronate-Related Femoral Fracture in a premenopausal glucocorticoid treated patient

    PubMed Central

    Mobini, Maryam

    2014-01-01

    Background: Alendronate is a bisphosphonate that is approved to reduce bone loss in glucocorticoid treated patients. In this paper, we present a case of femoral fracture following the use of Alendronate. Case presentation: A- 46 year old woman who was a known case of hemolytic anemia has been treated by prednisolone (with different doses from 7.5 to 75 mg/day), calcium-D 500 mg/day and alendronate 70 mg/week for 3 years. Despite improvement of bone density, she experienced a low truama femoral shaft fracture. Conclusion: This case shows a rare complication of treatment by alendronate. It may be needed to evaluate patients with long term usage of bisphosphonates for cortical thickness. PMID:24490015

  10. Alendronate-Related Femoral Fracture in a premenopausal glucocorticoid treated patient.

    PubMed

    Mobini, Maryam

    2014-01-01

    Alendronate is a bisphosphonate that is approved to reduce bone loss in glucocorticoid treated patients. In this paper, we present a case of femoral fracture following the use of Alendronate. A- 46 year old woman who was a known case of hemolytic anemia has been treated by prednisolone (with different doses from 7.5 to 75 mg/day), calcium-D 500 mg/day and alendronate 70 mg/week for 3 years. Despite improvement of bone density, she experienced a low truama femoral shaft fracture. This case shows a rare complication of treatment by alendronate. It may be needed to evaluate patients with long term usage of bisphosphonates for cortical thickness.

  11. Transient osteoporosis of the hip, complete resolution after treatment with alendronate as observed by MRI description of eight cases and review of the literature.

    PubMed

    Emad, Yasser; Ragab, Yasser; El-Shaarawy, Nashwa; Rasker, Johannes J

    2012-11-01

    Transient osteoporosis of the hip (TOH), also referred to as transient bone marrow edema syndrome, is most common in middle-aged men and often after trivial trauma or sport-related injuries. Diagnosis is usually made by eliminating other possible causes of hip pain. Magnetic resonance imaging (MRI) plays an important role in diagnosis and demonstrates a typical pattern of bone marrow edema (BME) in the form of diffuse low signal on T1-weighted images and high signal on T2 fat-suppressed or short T1 inversion recovery images. No consensus exists about the management of TOH, as it may progress to avascular necrosis. We describe eight cases of TOH treated with alendronate resulting in improvement of pain and function and complete resolution of BME on MRI. The literature is reviewed regarding TOH and the relationship with bone marrow edema syndrome, avascular necrosis of the hip, and regional migratory osteoporosis. To our knowledge, this is the first report describing the improvement of this condition after of alendronate with documented radiological improvement on follow-up MRI.

  12. Treatment and Outcomes of Aspergillosis

    MedlinePlus

    ... Treatment & Outcomes Health Professionals Statistics More Resources Candidiasis Candida infections of the mouth, throat, and esophagus Vaginal ... Sources Diagnosis Treatment Statistics Healthcare Professionals More Resources Candida auris General Information about Candida auris Tracking Candida ...

  13. Treatment and Outcomes of Histoplasmosis

    MedlinePlus

    ... Treatment & Outcomes Health Professionals Statistics More Resources Candidiasis Candida infections of the mouth, throat, and esophagus Vaginal ... Sources Diagnosis Treatment Statistics Healthcare Professionals More Resources Candida auris General Information about Candida auris Tracking Candida ...

  14. A randomized double-blind trial to compare the efficacy of teriparatide [recombinant human parathyroid hormone (1-34)] with alendronate in postmenopausal women with osteoporosis.

    PubMed

    Body, Jean-Jacques; Gaich, Gregory A; Scheele, Wim H; Kulkarni, Pandurang M; Miller, Paul D; Peretz, Anne; Dore, Robin K; Correa-Rotter, Ricardo; Papaioannou, Alexandra; Cumming, David C; Hodsman, Anthony B

    2002-10-01

    Teriparatide (rDNA origin) injection [recombinant human PTH (1-34)] stimulates bone formation, increases bone mineral density (BMD), and restores bone architecture and integrity. In contrast, bisphosphonates reduce bone resorption and increase BMD. We compared the effects of teriparatide and alendronate sodium on BMD, nonvertebral fracture incidence, and bone turnover in 146 postmenopausal women with osteoporosis. Women were randomized to either once-daily sc injections of teriparatide 40 micro g plus oral placebo (n = 73) or oral alendronate 10 mg plus placebo injection (n = 73). Median duration of treatment was 14 months. At 3 months, teriparatide increased lumbar spine BMD significantly more than did alendronate (P < 0.001). Lumbar spine-BMD increased by 12.2% in the teriparatide group and 5.6% in the alendronate group (P < 0.001 teriparatide vs. alendronate). Teriparatide increased femoral neck BMD and total body bone mineral significantly more than did alendronate, but BMD at the one third distal radius decreased, compared with alendronate (P < or = 0.05). Nonvertebral fracture incidence was significantly lower in the teriparatide group than in the alendronate group (P < 0.05). Both treatments were well tolerated despite transient mild asymptomatic hypercalcemia with teriparatide treatment. In conclusion, teriparatide, a bone formation agent, increased BMD at most sites and decreased nonvertebral fractures more than alendronate.

  15. Alendronate induces anti-migratory effects and inhibition of neutral phosphatases in UMR106 osteosarcoma cells.

    PubMed

    Molinuevo, M Silvina; Bruzzone, Liliana; Cortizo, Ana M

    2007-05-07

    Bisphosphonates are nonhydrolysable pyrophosphate analogues that prevent bone loss in several types of cancer. However, the mechanisms of anticancer action of bisphosphonates are not completely known. We have previously shown that nitrogen-containing bisphosphonates directly inhibit alkaline phosphatase of UMR106 rat osteosarcoma cells. In this study, we evaluated the effects of alendronate on the migration of UMR106 osteosarcoma using a model of multicellular cell spheroids, as well as the alendronate effect on neutral phosphatases. Alendronate significantly inhibited the migration of osteoblasts in a dose-dependent manner (10(-6)-10(-4) M). This effect was also dependent on calcium availability. The spheroid morphology and distribution of actin fibers were also affected by alendronate treatment. Alendronate dose-dependently inhibited neutral phosphatase activity in cell-free osteoblastic extracts as well as in osteoblasts in culture. Our results show that alendronate inhibits cell migration through mechanisms dependent on calcium, and that seem to involve inhibition of phosphotyrosine-neutral-phosphatases and disassembly of actin stress fibers.

  16. Burns: Treatment and Outcomes

    PubMed Central

    Burd, Andrew

    2010-01-01

    Burns can cause extensive and devastating injuries of the head and neck. Prevention of the initial injury must always be a priority, but once an injury has occurred, then prevention of progression of the damage together with survival of the patient must be the immediate goals. The acute care will have a major influence on the subsequent scarring, reconstructive need, and long-term outcome. In the majority of cases, the reconstruction will involve restoration of form and function to the soft tissues, and the methods used will depend very much on the extent of scarring locally and elsewhere in the body. In nearly all cases, a significant improvement in functional and aesthetic outcomes can be achieved, which, in conjunction with intensive psychosocial rehabilitation, can lead to high-quality patient outcomes. With the prospect of facial transplantation being a clinical reality, the reconstructive spectrum has opened up even further, and, with appropriate reconstruction and support, no patient should be left economically deprived or socially isolated after a burn injury. PMID:22550448

  17. Sustained response to intravenous alendronate in postmenopausal osteoporosis.

    PubMed

    Vasikaran, S D; Khan, S; McCloskey, E V; Kanis, J A

    1995-12-01

    We studied the effects of alendronate (amino-hydroxybutylidene bisphosphonate) on biochemical indices of bone turnover and on lumbar spinal bone mineral density in 15 postmenopausal women with vertebral osteoporosis. Alendronate 7.5 mg daily was administered intravenously as a slow infusion for four consecutive days. Treatment was associated with a significant decrease in serum calcium (p < 0.01), fasting urinary calcium excretion (p < 0.01) and hydroxyproline excretion within several days followed a later decrease in serum alkaline phosphatase activity that showed a significant reduction at two months after treatment (p < 0.05). Serum calcium reverted to pretreatment values by the second week after infusion, but the decrease in alkaline phosphatase, urinary calcium, and hydroxyproline excretion persisted to six months after infusion. There was a 3% mean increase in lumbar bone mineral density at six months (p < 0.01). A transient lymphopenia or leucopenia was noted in eight patients and a short-lived fever in six. No other side effects were observed. This study demonstrates that shortterm exposure to high intravenous doses of alendronate induces suppression of bone resorption in osteoporosis that persists for at least 6 months after infusion. We conclude that a short exposure to high intravenous doses induces sustained effects on bone turnover in much the same manner as that observed in Paget's disease of bone.

  18. Strontium ranelate and alendronate have differing effects on distal tibia bone microstructure in women with osteoporosis

    PubMed Central

    Laroche, Michel; Krieg, Marc-Antoine; Frieling, Isolde; Thomas, Thierry; Delmas, Pierre; Felsenberg, Dieter

    2010-01-01

    The structural basis of the antifracture efficacy of strontium ranelate and alendronate is incompletely understood. We compared the effects of strontium ranelate and alendronate on distal tibia microstructure over 2 years using HR-pQCT. In this pre-planned, interim, intention-to-treat analysis at 12 months, 88 osteoporotic postmenopausal women (mean age 63.7 ± 7.4) were randomized to strontium ranelate 2 g/day or alendronate 70 mg/week in a double-placebo design. Primary endpoints were changes in microstructure. Secondary endpoints included lumbar and hip areal bone mineral density (aBMD), and bone turnover markers. This trial is registered with http://www.controlled-trials.com, number ISRCTN82719233. Baseline characteristics of the two groups were similar. Treatment with strontium ranelate was associated with increases in mean cortical thickness (CTh, 5.3%), cortical area (4.9%) and trabecular density (2.1%) (all P < 0.001, except cortical area P = 0.013). No significant changes were observed with alendronate. Between-group differences in favor of strontium ranelate were observed for CTh, cortical area, BV/TV and trabecular density (P = 0.045, 0.041, 0.048 and 0.035, respectively). aBMD increased to a similar extent with strontium ranelate and alendronate at the spine (5.7% versus 5.1%, respectively) and total hip (3.3% versus 2.2%, respectively). No significant changes were observed in remodeling markers with strontium ranelate, while suppression was observed with alendronate. Within the methodological constraints of HR-pQCT through its possible sensitivity to X-ray attenuation of different minerals, strontium ranelate had greater effects than alendronate on distal tibia cortical thickness and trabecular volumetric density. PMID:20512336

  19. Alendronate increases skeletal mass of growing rats during unloading by inhibiting resorption of calcified cartilage

    NASA Technical Reports Server (NTRS)

    Bikle, D. D.; Morey-Holton, E. R.; Doty, S. B.; Currier, P. A.; Tanner, S. J.; Halloran, B. P.

    1994-01-01

    Loss of bone mass during periods of skeletal unloading remains an important clinical problem. To determine the extent to which resorption contributes to the relative loss of bone during skeletal unloading of the growing rat and to explore potential means of preventing such bone loss, 0.1 mg P/kg alendronate was administered to rats before unloading of the hindquarters. Skeletal unloading markedly reduced the normal increase in tibial mass and calcium content during the 9 day period of observation, primarily by decreasing bone formation, although bone resorption was also modestly stimulated. Alendronate not only prevented the relative loss of skeletal mass during unloading but led to a dramatic increase in calcified tissue in the proximal tibia compared with the vehicle-treated unloaded or normally loaded controls. Bone formation, however, assessed both by tetracycline labeling and by [3H]proline and 45Ca incorporation, was suppressed by alendronate treatment and further decreased by skeletal unloading. Total osteoclast number increased in alendronate-treated animals, but values were similar to those in controls when corrected for the increased bone area. However, the osteoclasts had poorly developed brush borders and appeared not to engage the bone surface when examined at the ultrastructural level. We conclude that alendronate prevents the relative loss of mineralized tissue in growing rats subjected to skeletal unloading, but it does so primarily by inhibiting the resorption of the primary and secondary spongiosa, leading to altered bone modeling in the metaphysis.

  20. The effect of alendronate sodium on alveolar bone loss in periodontitis (clinical trial).

    PubMed

    El-Shinnawi, Una M; El-Tantawy, Salah Ibrahim

    2003-01-01

    Alendronate sodium is a potent inhibitor of bone resorption which has been effectively used to control osteolysis, and to treat Paget's disease and osteoporosis. The objective of this study was to investigate the effect of alendronate sodium, systemically induced in the treatment of patients with periodontitis. Twenty-four adult periodontitis patients were included in the study (for six months) and were divided into two groups. Group I, included twelve patients who received one tablet of fosamax (alendronate sodium, MSD) every morning for six months. Group II, also included twelve patients who received no drug during the study period. All patients received initial periodontal therapy. Bone mineral density (BMD) of the maxilla and mandible was measured for all subjects using a dual energy absorptiometer (DEXA) at the beginning of the study and at the end of six months using DPX. MD Scanner. Clinical periodontal measurements were carried out for all patients at the initial appointment and six months later in the form of pocket depth, attachment level and gingival index. A statistically significant difference in bone density (P < 0.001) was observed favouring the alendronate group (Group I). Alendronate sodium had no effect on the clinical parameters and could play an important role as an adjunct to conventional periodontal therapy in management of periodontal diseases.

  1. Alendronate increases skeletal mass of growing rats during unloading by inhibiting resorption of calcified cartilage

    NASA Technical Reports Server (NTRS)

    Bikle, D. D.; Morey-Holton, E. R.; Doty, S. B.; Currier, P. A.; Tanner, S. J.; Halloran, B. P.

    1994-01-01

    Loss of bone mass during periods of skeletal unloading remains an important clinical problem. To determine the extent to which resorption contributes to the relative loss of bone during skeletal unloading of the growing rat and to explore potential means of preventing such bone loss, 0.1 mg P/kg alendronate was administered to rats before unloading of the hindquarters. Skeletal unloading markedly reduced the normal increase in tibial mass and calcium content during the 9 day period of observation, primarily by decreasing bone formation, although bone resorption was also modestly stimulated. Alendronate not only prevented the relative loss of skeletal mass during unloading but led to a dramatic increase in calcified tissue in the proximal tibia compared with the vehicle-treated unloaded or normally loaded controls. Bone formation, however, assessed both by tetracycline labeling and by [3H]proline and 45Ca incorporation, was suppressed by alendronate treatment and further decreased by skeletal unloading. Total osteoclast number increased in alendronate-treated animals, but values were similar to those in controls when corrected for the increased bone area. However, the osteoclasts had poorly developed brush borders and appeared not to engage the bone surface when examined at the ultrastructural level. We conclude that alendronate prevents the relative loss of mineralized tissue in growing rats subjected to skeletal unloading, but it does so primarily by inhibiting the resorption of the primary and secondary spongiosa, leading to altered bone modeling in the metaphysis.

  2. Cinacalcet hydrochloride in combination with alendronate normalizes hypercalcemia and improves bone mineral density in patients with primary hyperparathyroidism.

    PubMed

    Faggiano, A; Di Somma, C; Ramundo, V; Severino, R; Vuolo, L; Coppola, A; Panico, F; Savastano, S; Lombardi, G; Colao, A; Gasperi, M

    2011-06-01

    Cinacalcet is effective in controlling the biochemical abnormalities in patients with primary hyperparathyroidism (PHPT) but it seems to be less effective on bone mineral density (BMD). In the same patients, bisphosphonates are reported to be effective on bone resorption but less effective on calcium and PTH excess. In this study, the efficacy of cinacalcet in combination with alendronate has been retrospectively evaluated in patients with PHPT. Twenty-three patients with PHPT who had not been operated were retrospectively investigated. Cinacalcet was evaluated in combination with alendronate in 10 of the 23 patients, and in monotherapy in 13 other patients. Serum calcium, phosphorus and PTH, 24 h urine calcium and phosphorus as well as BMD, evaluated by DXA and expressed as T-score, were measured before and after treatment. In all patients serum calcium and phosphorus and urinary calcium excretion were effectively and stably controlled and PTH was significantly decreased after treatment. There was no difference in the rate of serum calcium and PTH decrease between subjects treated with cinacalcet plus alendronate and those treated with cinacalcet alone. T-score increased by 9.6% at lumbar spine and 3.9% at femur level in the cinacalcet plus alendronate subgroup and was unchanged in the cinacalcet subgroup (P < 0.01). In patients with PHPT, the biochemical abnormalities are rapidly improved by cinacalcet regardless from the administration in monotherapy or in combination with alendronate. BMD is significantly improved in patients receiving cinacalcet plus alendronate and stable in those receiving cinacalcet in monotherapy.

  3. Alendronate Sodium as Enteric Coated Solid Lipid Nanoparticles; Preparation, Optimization, and In Vivo Evaluation to Enhance Its Oral Bioavailability

    PubMed Central

    Hosny, Khaled Mohamed

    2016-01-01

    Treatment of osteoporosis with alendronate sodium has several challenges. The first challenge is the low bioavailability. The second main challenge is side effects, which include oesophageal ulceration. The aim of this research was to reformulate alendronate sodium as enteric coated solid lipid nanoparticles in order to enhance its bioavailability, and preventing the free alendronate sodium from coming into direct contact with the gastrointestinal mucosa, and thereby reducing the possibility of side effects. Enteric coated solid lipid nanoparticles were prepared according to the Box-Behnken design employing Design expert® software, and characterized for size, morphology, and entrapment efficiency. The optimized formula was coated with an Eudragit S100 and evaluated for drug release in acidic and basic media, stability studies and pharmacokinetic evaluations on rabbits. The results indicated that, using Derringer's desirability functional tool for optimization, the highest entrapment efficiency value of 74.3% and the smallest size value of 98 nm were predicted under optimum conditions with a desirability value of 0.917. The optimized nanoparticles released alendronate sodium only at an alkaline pH. The pharmacokinetic evaluation revealed that alendronate sodium bioavailability was enhanced by more than 7.4-fold in rabbits. In conclusion, enteric coated solid lipid nanoparticles is a promising formula for the delivery of alendronate sodium, eliminating its oesophageal side effects and enhancing its bioavailability. PMID:27148747

  4. Alendronate Sodium as Enteric Coated Solid Lipid Nanoparticles; Preparation, Optimization, and In Vivo Evaluation to Enhance Its Oral Bioavailability.

    PubMed

    Hosny, Khaled Mohamed

    2016-01-01

    Treatment of osteoporosis with alendronate sodium has several challenges. The first challenge is the low bioavailability. The second main challenge is side effects, which include oesophageal ulceration. The aim of this research was to reformulate alendronate sodium as enteric coated solid lipid nanoparticles in order to enhance its bioavailability, and preventing the free alendronate sodium from coming into direct contact with the gastrointestinal mucosa, and thereby reducing the possibility of side effects. Enteric coated solid lipid nanoparticles were prepared according to the Box-Behnken design employing Design expert® software, and characterized for size, morphology, and entrapment efficiency. The optimized formula was coated with an Eudragit S100 and evaluated for drug release in acidic and basic media, stability studies and pharmacokinetic evaluations on rabbits. The results indicated that, using Derringer's desirability functional tool for optimization, the highest entrapment efficiency value of 74.3% and the smallest size value of 98 nm were predicted under optimum conditions with a desirability value of 0.917. The optimized nanoparticles released alendronate sodium only at an alkaline pH. The pharmacokinetic evaluation revealed that alendronate sodium bioavailability was enhanced by more than 7.4-fold in rabbits. In conclusion, enteric coated solid lipid nanoparticles is a promising formula for the delivery of alendronate sodium, eliminating its oesophageal side effects and enhancing its bioavailability.

  5. Alendronate Treatment of the Brtl Osteogenesis Imperfecta Mouse Improves Femoral Geometry and Load Response Before Fracture but Decreases Predicted Material Properties and Has Detrimental Effects on Osteoblasts and Bone Formation

    PubMed Central

    Uveges, Thomas E.; Kozloff, Kenneth M.; Ty, Jennifer M.; Ledgard, Felicia; Raggio, Cathleen L.; Gronowicz, Gloria; Goldstein, Steven A.; Marini, Joan C.

    2009-01-01

    Long courses of bisphosphonates are widely administered to children with osteogenesis imperfecta (OI), although bisphosphonates do not block mutant collagen secretion and may affect bone matrix composition or structure. The Brtl mouse has a glycine substitution in col1a1 and is ideal for modeling the effects of bisphosphonate in classical OI. We treated Brtl and wildtype mice with alendronate (Aln; 0.219 mg/kg/wk, SC) for 6 or 12 wk and compared treated and untreated femora of both genotypes. Mutant and wildtype bone had similar responses to Aln treatment. Femoral areal BMD and cortical volumetric BMD increased significantly after 12 wk, but femoral length and growth curves were unaltered. Aln improved Brtl diaphyseal cortical thickness and trabecular number after 6 wk and cross-sectional shape after 12 wk. Mechanically, Aln significantly increased stiffness in wildtype femora and load to fracture in both genotypes after 12 wk. However, predicted material strength and elastic modulus were negatively impacted by 12 wk of Aln in both genotypes, and metaphyseal remnants of mineralized cartilage also increased. Brtl femoral brittleness was unimproved. Brtl osteoclast and osteoblast surface were unchanged by treatment. However, decreased mineral apposition rate and bone formation rate/bone surface and the flattened morphology of Brtl osteoblasts suggested that Aln impaired osteoblast function and matrix synthesis. We conclude that Aln treatment improves Brtl femoral geometry and load to fracture but decreases bone matrix synthesis and predicted material modulus and strength, with striking retention of mineralized cartilage. Beneficial and detrimental changes appear concomitantly. Limiting cumulative bisphosphonate exposure of OI bone will minimize detrimental effects. PMID:19113917

  6. Clinical tuberculosis and treatment outcomes.

    PubMed

    Jordan, T S; Davies, P D

    2010-06-01

    The global targets for tuberculosis (TB) control set by the World Health Assembly (WHA) in 1991 were detection of at least 70% and cure of at least 85% of new sputum smear-positive TB cases by 2000, later revised to 2005. The DOTS strategy was introduced in the mid-1990s, and later became the cornerstone of the Stop TB Strategy, which was launched along with the Global Plan to Stop TB 2006-2015 in 2006. The Global Plan sets out how and to what extent the Stop TB Strategy should be implemented between 2006 and 2015 to achieve the TB-related Millennium Development Goal (MDG) to halt and reverse the incidence of TB by 2015 and the Stop TB Partnership targets to reduce TB prevalence and death rates to 50% of 1990 levels by 2015, and to eliminate TB as a public health concern by 2050. Treatment success and case detection rates are outcome indicators used to measure the effectiveness of TB control along with the impact indicators incidence, prevalence and death rates. Globally, the rate of treatment success for smear-positive cases treated exceeded the WHA global target of 85% for the first time in 2007. This review focuses on articles related to treatment outcome in TB published in the International Journal of Tuberculosis and Lung Disease in 2009.

  7. Inhibition of mevalonate pathway is involved in alendronate-induced cell growth inhibition, but not in cytokine secretion from macrophages in vitro.

    PubMed

    Töyräs, Anu; Ollikainen, Jouko; Taskinen, Markku; Mönkkönen, Jukka

    2003-07-01

    Bisphosphonates are antiresorptive drugs used for the treatment of metabolic bone diseases. They can be divided into two different pharmacological classes: nitrogen-containing and non-nitrogen-containing bisphosphonates. Non-nitrogen-containing bisphosphonates, like clodronate, are metabolised to a toxic ATP-analogue preventing osteoclast mediated bone resorption. Nitrogen-containing bisphosphonates, including alendronate, prevent osteoclast function by inhibiting the mevalonate pathway. Clodronate is known to have anti-inflammatory properties while alendronate induces cytokine secretion from lipopolysaccharide- (LPS) induced macrophages. This study investigates whether the cytotoxicity and cytokine production induced by alendronate and LPS could be counteracted by clodronate or products of mevalonate pathway: oxidized low density lipoprotein (ox-LDL), farnesol and geranylgeraniol. Treatment with alendronate increased LPS-induced secretion of IL-1beta, IL-6 and TNF-alpha from RAW 264 macrophages 2.4-, 1.4- and 1.8-fold, respectively. This treatment was cytotoxic for macrophages as indicated by lowered cell viability. Clodronate and ox-LDL both counteracted the cytokine secretion and cytotoxicity of alendronate. Farnesol and geranylgeraniol did neither reverse the cytokine secretion nor reduce the cytotoxicity of alendronate. Clodronate and ox-LDL were able to counteract the effects of alendronate on macrophages in vitro, probably by their known ability to inhibit DNA binding activity of transcription factors, nuclear factor-kappaB (NF-kappaB) and activating protein-1 (AP-1). These findings suggest that inhibition of mevalonate pathway is not the mechanism responsible for the proinflammatory response caused by alendronate, as it is in alendronate-induced apoptosis and prevention of osteoclast function.

  8. Skeletal Health After Continuation, Withdrawal, or Delay of Alendronate in Men With Prostate Cancer Undergoing Androgen-Deprivation Therapy

    PubMed Central

    Greenspan, Susan L.; Nelson, Joel B.; Trump, Donald L.; Wagner, Julie M.; Miller, Megan E.; Perera, Subashan; Resnick, Neil M.

    2008-01-01

    Purpose Androgen-deprivation therapy (ADT) for prostate cancer is associated with bone loss and osteoporotic fractures. Our objective was to examine changes in bone density and turnover with sustained, discontinued, or delayed oral bisphosphonate therapy in men receiving ADT. Patients and Methods A total of 112 men with nonmetastatic prostate cancer receiving ADT were randomly assigned to alendronate 70 mg once weekly or placebo in a double-blind, partial-crossover trial with a second random assignment at year 2 for those who initially received active therapy. Outcomes included bone mineral density and bone turnover markers. Results Men initially randomly assigned to alendronate and randomly reassigned at year 2 to continue had additional bone density gains at the spine (mean, 2.3% ± 0.7) and hip (mean, 1.3% ± 0.5%; both P < .01); those randomly assigned to placebo in year 2 maintained density at the spine and hip but lost (mean, −1.9% ± 0.6%; P < .01) at the forearm. Patients randomly assigned to begin alendronate in year 2 experienced improvements in bone mass at the spine and hip, but experienced less of an increase compared with those who initiated alendronate at baseline. Men receiving alendronate for 2 years experienced a mean 6.7% (± 1.2%) increase at the spine and a 3.2% (± 1.5%) at the hip (both P < .05). Bone turnover remained suppressed. Conclusion Among men with nonmetastatic prostate cancer receiving ADT, once-weekly alendronate improves bone density and decreases turnover. A second year of alendronate provides additional skeletal benefit, whereas discontinuation results in bone loss and increased bone turnover. Delay in bisphosphonate therapy appears detrimental to bone health. PMID:18802155

  9. Pharmacokinetics of coadministration of levothyroxine sodium and alendronate sodium new effervescent formulation.

    PubMed

    Bone, H G; Walter, M A; Hurley, M E; Epstein, S

    2017-02-16

    No clinically important pharmacokinetic interference of alendronate occurred between a new effervescent formulation of alendronate and levothyroxine when coadministered. The combination does not materially affect levothyroxine absorption.

  10. Safety and effectiveness of teriparatide vs alendronate in postmenopausal osteoporosis: a prospective non randomized clinical study

    PubMed Central

    Caggiari, Gianfilippo; Leali, Paolo Tranquilli; Mosele, Giulia Raffaella; Puddu, Leonardo; Badessi, Francesca; Doria, Carlo

    2016-01-01

    Summary In this work we study the safety and effectiveness of teriparatide and alendronate in patients with postmenopausal osteoporosis at high risk of fracture; it was a double-blinded and it was done by examining the comparisons between teriparatide 20 μg/day and alendronate 10 mg/day. Safety and effectiveness analyses were based on data from 355 woman with a mean age of 68 years. Two groups (A and B) with T-score ≤–2.5 at bone mineral density were analyzed and 3 or more vertebral fractures on radiograph. Group A: was treated with teriparatide 20 μg/day and composed from 182 women, in post-menopausal age, without a history of cancer. Group B: was treated with alendronate 10 mg/day composed from 173 women, postmenopausal age, with previous history of cancer (non-active during the study). Clinical evaluations were on bone turnover markers (alkaline phosphatase, procollagene type 1 N-terminal propeptide, and N-telopeptide cross-links), dual-energy X-ray absorptiometry and health-related quality of life (HrQoL). Safety was assessed by reporting of adverse drug reactions (ADRs). The results of this study imply that teriparatide comparated with alendronate has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture. PMID:28228782

  11. Safety and effectiveness of teriparatide vs alendronate in postmenopausal osteoporosis: a prospective non randomized clinical study.

    PubMed

    Caggiari, Gianfilippo; Leali, Paolo Tranquilli; Mosele, Giulia Raffaella; Puddu, Leonardo; Badessi, Francesca; Doria, Carlo

    2016-01-01

    In this work we study the safety and effectiveness of teriparatide and alendronate in patients with postmenopausal osteoporosis at high risk of fracture; it was a double-blinded and it was done by examining the comparisons between teriparatide 20 μg/day and alendronate 10 mg/day. Safety and effectiveness analyses were based on data from 355 woman with a mean age of 68 years. Two groups (A and B) with T-score ≤-2.5 at bone mineral density were analyzed and 3 or more vertebral fractures on radiograph. Group A: was treated with teriparatide 20 μg/day and composed from 182 women, in post-menopausal age, without a history of cancer. Group B: was treated with alendronate 10 mg/day composed from 173 women, postmenopausal age, with previous history of cancer (non-active during the study). Clinical evaluations were on bone turnover markers (alkaline phosphatase, procollagene type 1 N-terminal propeptide, and N-telopeptide cross-links), dual-energy X-ray absorptiometry and health-related quality of life (HrQoL). Safety was assessed by reporting of adverse drug reactions (ADRs). The results of this study imply that teriparatide comparated with alendronate has a favorable safety profile and is effective in the treatment of patients with osteoporosis at high risk of fracture.

  12. Ultrastructural and biochemical analysis of the effects of alendronate on salivary glands of young rats.

    PubMed

    Oliveira, Taís C; Bradaschia-Correa, Vivian; Castro, Juliana R; Simões, Alyne; Arana-Chavez, Victor E

    2014-12-01

    The bisphosphonates are drugs known by their antiresorptive potency and are widely prescribed for treating and preventing osteoporosis. In the past years the employment of this class of drugs had spread to other pathologies, and it is being prescribed to patients in a wide range of ages. Some adverse effects of bisphosphonate treatment have been highlighted recently, however, little is known about its potential side effects in salivary glands. Newborn rats received daily doses of 2.5mg/kg/day of sodium alendronate during 30 days. On the thirtieth day the animals were stimulated with pilocarpine and their parotid and submandibular glands were collected, fixed and embedded for histological and ultrastructural analysis. Some glands were collected for analysis of protein content and amylase activity. At light microscopy, the alendronate-treated animals presented an accumulation of secretion granules in their cytoplasm, which was confirmed by the ultrastructural examination. Biochemical analysis revealed an increase in total protein content and decreased amylase levels of both glands in the alendronate-treated animals in relation to the control. Based on the current findings, alendronate is probably interfering in secretory pathways of parotid and submandibular glands. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. Targeting treatment for optimal outcome.

    PubMed

    Husted, S E

    2000-01-01

    Rapid assessment of patients presenting with acute chest pain is essential, in order to distinguish between those who have a life-threatening condition, such as myocardial infarction or unstable angina, and the substantial proportion who do not have an acute coronary syndrome. It is thus of vital importance that reliable techniques are available to facilitate rapid risk stratification, as an aid to both clinical diagnosis and management strategy decisions. Assessments based on clinical findings, electrocardiographic monitoring, symptom-limited exercise testing, and biochemical marker measurements, used either singly or in various combinations, can fulfill this role. The present paper reviews some of the recent data that demonstrate the value of these techniques. Very few studies allow conclusions to be drawn about optimal treatment strategies in relation to groups stratified according to prognostic markers, and the question of whether intense medical treatment or early invasive intervention is most beneficial is one that clinical trials have yet to address adequately. In the recently completed Fragmin and Fast Revascularization during InStability in Coronary artery disease (FRISC II) study, comparisons were made of clinical outcomes achieved with early invasive versus noninvasive (i.e., medical) management strategies, and with short-term versus prolonged anticoagulation with dalteparin sodium (Fragmin), in patients with unstable coronary artery disease. All study participants underwent symptom-limited exercise testing and provided blood sample for measurements of biochemical markers; continuous electrocardiography monitoring and echocardiography were also performed in a high proportion of patients. Data from the FRISC II trial thus shed further light on the issue of risk stratification and its use to determine optimal treatment strategies.

  14. Treatment Outcomes and Efficacy in the Schools.

    ERIC Educational Resources Information Center

    Logemann, Jeri A.

    1998-01-01

    Introduces six articles which address treatment outcomes and efficacy in audiology and speech-language pathology in the schools. Stresses the importance of practitioners participating in studies of treatment outcomes and efficacy to demonstrate that their evaluations and treatments make a significant difference to individuals served. (DB)

  15. Alendronate-coated long-circulating liposomes containing 99mtechnetium-ceftizoxime used to identify osteomyelitis

    PubMed Central

    Ferreira, Diego dos Santos; Boratto, Fernanda Alves; Cardoso, Valbert Nascimento; Serakides, Rogéria; Fernandes, Simone Odília; Ferreira, Lucas Antônio Miranda; Oliveira, Mônica Cristina

    2015-01-01

    Osteomyelitis is a progressive destruction of bones caused by microorganisms. Inadequate or absent treatment increases the risk of bone growth inhibition, fractures, and sepsis. Among the diagnostic techniques, functional images are the most sensitive in detecting osteomyelitis in its early stages. However, these techniques do not have adequate specificity. By contrast, radiolabeled antibiotics could improve selectivity, since they are specifically recognized by the bacteria. The incorporation of these radiopharmaceuticals in drug-delivery systems with high affinity for bones could improve the overall uptake. In this work, long-circulating and alendronate-coated liposomes containing 99mtechnetium-radiolabeled ceftizoxime were prepared and their ability to identify infectious foci (osteomyelitis) in animal models was evaluated. The effect of the presence of PEGylated lipids and surface-attached alendronate was evaluated. The bone-targeted long-circulating liposomal 99mtechnetium–ceftizoxime showed higher uptake in regions of septic inflammation than did the non-long-circulating and/or alendronate-non-coated liposomes, showing that both the presence of PEGylated lipids and alendronate coating are important to optimize the bone targeting. Scintigraphic images of septic or aseptic inflammation-bearing Wistar rats, as well as healthy rats, were acquired at different time intervals after the intravenous administration of these liposomes. The target-to-non-target ratio proved to be significantly higher in the osteomyelitis-bearing animals for all investigated time intervals. Biodistribution studies were also performed after the intravenous administration of the formulation in osteomyelitis-bearing animals. A significant amount of liposomes were taken up by the organs of the mononuclear phagocyte system (liver and spleen). Intense renal excretion was also observed during the entire experiment period. Moreover, the liposome uptake by the infectious focus was significantly

  16. Prevention of aromatase inhibitor-induced bone loss with alendronate in postmenopausal women: The BATMAN Trial.

    PubMed

    Lomax, Anna J; Yee Yap, Saw; White, Karen; Beith, Jane; Abdi, Ehtesham; Broad, Adam; Sewak, Sanjeev; Lee, Chooi; Sambrook, Philip; Pocock, Nicholas; Henry, Margaret J; Yeow, Elaine G; Bell, Richard

    2013-12-01

    Postmenopausal women on aromatase inhibitors (AI) are at risk of aromatase inhibitor-associated bone loss (AIBL) and fractures. In 2005 Osteoporosis Australia proposed an algorithm for bisphosphonate intervention. Three hundred and three postmenopausal women with early breast cancer (EBC) were enrolled (osteoporotic, n=25; osteopaenic, n=146; normal bone mineral density (BMD), n=126). Weekly alendronate (70 mg) treatment efficacy as triggered by the algorithm in preventing bone loss was evaluated. All patients received anastrozole (1 mg daily), calcium and vitamin D. All osteoporotic patients received alendronate at baseline. Eleven out of the 146 (7.5%) osteopaenic patients commenced alendronate within 18 months of participation and eleven commenced after. One hundred and twenty four out of the 146 (84.9%) osteopaenic patients and all 126 with normal baseline BMD did not trigger the algorithm. At three years, lumbar spine mean BMD increased (15.6%, p<0.01) in the osteoporotic group. BMD in the osteopaenic group with early intervention significantly increased at three years (6.3%, p=0.02). No significant change was seen in the late intervention group. No change was observed in those with osteopaenia without alendronate. There was a significant drop in lumbar spine (-5.4%) and hip (-4.5%) mean BMD, in the normal BMD group, none of whom received alendronate. Fracture data will be presented. In postmenopausal women with endocrine-responsive EBC, BMD improved over time when a bisphosphonate is administered with anastrozole in osteoporotic patients using an osteoporosis schedule. Subjects with normal baseline BMD experienced the greatest BMD loss, although none became osteoporotic.

  17. Alendronate-coated long-circulating liposomes containing 99mtechnetium-ceftizoxime used to identify osteomyelitis.

    PubMed

    Ferreira, Diego dos Santos; Boratto, Fernanda Alves; Cardoso, Valbert Nascimento; Serakides, Rogéria; Fernandes, Simone Odília; Ferreira, Lucas Antônio Miranda; Oliveira, Mônica Cristina

    2015-01-01

    Osteomyelitis is a progressive destruction of bones caused by microorganisms. Inadequate or absent treatment increases the risk of bone growth inhibition, fractures, and sepsis. Among the diagnostic techniques, functional images are the most sensitive in detecting osteomyelitis in its early stages. However, these techniques do not have adequate specificity. By contrast, radiolabeled antibiotics could improve selectivity, since they are specifically recognized by the bacteria. The incorporation of these radiopharmaceuticals in drug-delivery systems with high affinity for bones could improve the overall uptake. In this work, long-circulating and alendronate-coated liposomes containing (99m)technetium-radiolabeled ceftizoxime were prepared and their ability to identify infectious foci (osteomyelitis) in animal models was evaluated. The effect of the presence of PEGylated lipids and surface-attached alendronate was evaluated. The bone-targeted long-circulating liposomal (99m)technetium-ceftizoxime showed higher uptake in regions of septic inflammation than did the non-long-circulating and/or alendronate-non-coated liposomes, showing that both the presence of PEGylated lipids and alendronate coating are important to optimize the bone targeting. Scintigraphic images of septic or aseptic inflammation-bearing Wistar rats, as well as healthy rats, were acquired at different time intervals after the intravenous administration of these liposomes. The target-to-non-target ratio proved to be significantly higher in the osteomyelitis-bearing animals for all investigated time intervals. Biodistribution studies were also performed after the intravenous administration of the formulation in osteomyelitis-bearing animals. A significant amount of liposomes were taken up by the organs of the mononuclear phagocyte system (liver and spleen). Intense renal excretion was also observed during the entire experiment period. Moreover, the liposome uptake by the infectious focus was

  18. Characteristics Associated with Bone Mineral Density Responses to Alendronate in Men

    PubMed Central

    Swenson, Erik D.; Hansen, Karen E.; Jones, Andrea N.; Li, Zhanhai; Baltz, Brooke; Schuna, Arthur A.; Elliott, Mary E.

    2015-01-01

    Background Some patients experience reduced bone mineral density (BMD) despite bisphosphonate therapy. We performed a retrospective chart review study to detect factors associated with decreased BMD in men prescribed alendronate. Methods Two investigators reviewed eligible medical records and used a standardized form to record potential characteristics predicting men’s response to alendronate. We analyzed patient characteristics associated with annualized change in hip and spine BMD (D-BMD). Results Among 115 eligible men, 19 (17%) experienced significantly decreased BMD at the hip or spine, defined as a change exceeding precision error. Eleven men (10%) fractured during therapy. Spine D-BMD was positively associated with adherence to alendronate (R = 0.23, p=0.02) and inversely associated with baseline body weight (R = −0.21, p=0.03). Hip D-BMD was positively associated with annualized weight change (R = 0.19, p=0.0498) and negatively associated with patient age and number of concomitant medications (R = −0.21, p=0.03; R = −0.20, p = 0.03, respectively). In stepwise linear models, spine D-BMD was positively associated with alendronate adherence and multivitamin use, and negatively with baseline body weight. Hip D-BMD was negatively associated with age. Fracture during treatment was associated with fracture prior to therapy (p=0.03) Conclusions In this small study of men prescribed alendronate, BMD response showed a positive association with adherence to therapy, weight gain, and use of a multivitamin. By contrast, older age, higher baseline body weight, and higher number of medications were each associated with a decrease in BMD. Larger studies are needed to confirm and extend these findings. PMID:23494407

  19. Characteristics associated with bone mineral density responses to alendronate in men.

    PubMed

    Swenson, Erik D; Hansen, Karen E; Jones, Andrea N; Li, Zhanhai; Baltz-Ward, Brooke; Schuna, Arthur A; Elliott, Mary E

    2013-06-01

    Some patients experience reduced bone mineral density (BMD) despite bisphosphonate therapy. We performed a retrospective chart review study to detect factors associated with decreased BMD in men prescribed alendronate. Two investigators reviewed eligible medical records and used a standardized form to record potential characteristics predicting men's response to alendronate. We analyzed patient characteristics associated with annualized change in hip and spine BMD (D-BMD). Among 115 eligible men, 19 (17 %) experienced significantly decreased BMD at the hip or spine, defined as a change exceeding precision error. Eleven men (10 %) fractured during therapy. Spine D-BMD was positively associated with adherence to alendronate (R = 0.23, p = 0.02) and inversely associated with baseline body weight (R = -0.21, p = 0.03). Hip D-BMD was positively associated with annualized weight change (R = 0.19, p = 0.0498) and negatively associated with patient age and number of concomitant medications (R = -0.21, p = 0.03; R = -0.20, p = 0.03, respectively). In stepwise linear models, spine D-BMD was associated positively with alendronate adherence and multivitamin use and negatively with baseline body weight. Hip D-BMD was negatively associated with age. Fracture during treatment was associated with fracture prior to therapy (p = 0.03). In this small study of men prescribed alendronate, BMD response showed a positive association with adherence to therapy, weight gain, and use of a multivitamin. By contrast, older age, higher baseline body weight, and higher number of medications were each associated with a decrease in BMD. Larger studies are needed to confirm and extend these findings.

  20. Short term sodium alendronate administration improves the peri-implant bone quality in osteoporotic animals

    PubMed Central

    de OLIVEIRA, Danila; HASSUMI, Jaqueline Suemi; GOMES-FERREIRA, Pedro Henrique da Silva; POLO, Tárik Ocon Braga; FERREIRA, Gabriel Ramalho; FAVERANI, Leonardo Perez; OKAMOTO, Roberta

    2017-01-01

    Abstract Sodium alendronate is a bisphosphonate drug that exerts antiresorptive action and is used to treat osteoporosis. Objective The aim of this study was to evaluate the bone repair process at the bone/implant interface of osteoporotic rats treated with sodium alendronate through the analysis of microtomography, real time polymerase chain reactions and immunohistochemistry (RUNX2 protein, bone sialoprotein (BSP), alkaline phosphatase, osteopontin and osteocalcin). Material and Methods A total of 42 rats were used and divided in to the following experimental groups: CTL: control group (rats submitted to fictitious surgery and fed with a balanced diet), OST: osteoporosis group (rats submitted to a bilateral ovariectomy and fed with a low calcium diet) and ALE: alendronate group (rats submitted to a bilateral ovariectomy, fed with a low calcium diet and treated with sodium alendronate). A surface treated implant was installed in both tibial metaphyses of each rat. Euthanasia of the animals was conducted at 14 (immunhostochemistry) and 42 days (immunohistochemistry, micro CT and PCR). Data were subjected to statistical analysis with a 5% significance level. Results Bone volume (BV) and total pore volume were higher for ALE group (P<0.05). Molecular data for RUNX2 and BSP proteins were significantly expressed in the ALE group (P<0.05), in comparison with the other groups. ALP expression was higher in the CTL group (P<0.05). The immunostaining for RUNX2 and osteopontin was positive in the osteoblastic lineage cells of neoformed bone for the CTL and ALE groups in both periods (14 and 42 days). Alkaline phosphatase presented a lower staining area in the OST group compared to the CTL in both periods and the ALE at 42 days. Conclusion There was a decrease of osteocalcin precipitation at 42 days for the ALE and OST groups. Therefore, treatment with short-term sodium alendronate improved bone repair around the implants installed in the tibia of osteoporotic rats. PMID

  1. Bisphosphonates alendronate and ibandronate inhibit artery calcification at doses comparable to those that inhibit bone resorption.

    PubMed

    Price, P A; Faus, S A; Williamson, M K

    2001-05-01

    The present experiments were carried out to test the hypothesis that artery calcification is linked to bone resorption by determining whether the selective inhibition of bone resorption with the bisphosphonates alendronate and ibandronate will inhibit artery calcification. Artery calcification was first induced by treatment of 42-day-old male rats with warfarin, a procedure that inhibits the gamma-carboxylation of matrix Gla protein and has been shown to cause extensive calcification of the artery media within 2 weeks. These experiments revealed that ibandronate (0.05 mg. kg(-1). d(-1)) and alendronate (0.1 mg x kg(-1) x d(-1)) completely inhibited calcification of all arteries and heart valves examined after 2 and 4 weeks of warfarin treatment. A 10-fold lower dose of alendronate reduced artery calcification by 50% (P<0.005). These bisphosphonate doses are comparable to those that inhibit bone resorption in rats of this age. More rapid artery calcification was induced by treatment with warfarin together with high doses of vitamin D, a procedure that causes extensive artery calcification by 84 hours. Alendronate and ibandronate again completely inhibited calcification of all arteries and heart valves examined. The subcutaneous doses of alendronate and ibandronate necessary to inhibit artery calcification are comparable to the daily subcutaneous doses of these drugs that have previously been shown to inhibit bone resorption in rats of the same age, with 50% inhibition of artery calcification at 20 microg alendronate x kg(-1) x d(-1) and at 1 microg ibandronate x kg(-1) x d(-1) x Bisphosphonate treatment did not affect serum calcium and phosphate, and so the inhibition of artery calcification cannot be due to a simple lowering of the serum calcium phosphate ion product. We conclude that bisphosphonates inhibit the calcification of arteries and heart valves at doses comparable to the doses that inhibit bone resorption. These results support the hypothesis that artery

  2. Esophageal irritation due to alendronate sodium tablets: possible mechanisms.

    PubMed

    Peter, C P; Handt, L K; Smith, S M

    1998-09-01

    Animal studies were done using an in vivo dog model to examine the possible mechanism for the esophageal adverse events reported with alendronate sodium tablets. These studies showed that under low pH conditions alendronate sodium can cause esophageal irritation. No esophageal irritation occurred at pH 3.5 or higher where the drug exists primarily as the sodium salt. The animal studies also showed that alendronate sodium can exacerbate preexisting esophageal damage. Exposure of the esophageal mucosa for a prolonged period to alendronate sodium tablet can also cause mild esophageal irritation. These findings suggest that the esophageal irritation in patients taking Fosamax can be from prolonged contact with the tablet, reflux of acidic gastric contents with alendronate sodium, and exacerbation of preexisting esophageal damage. The findings also suggest that other bisphosphonates can cause esophageal injury under similar conditions.

  3. Comparing Tolerability and Efficacy of Generic versus Brand Alendronate: A Randomized Clinical Study in Postmenopausal Women with a Recent Fracture

    PubMed Central

    van den Bergh, Joop P. W.; Bouts, Marian E.; van der Veer, Eveline; van der Velde, Robert Y.; Janssen, Marcel J. W.; Geusens, Piet P.; Winkens, Bjorn; Oldenhof, Nico J. J.; van Geel, Tineke A. C. M.

    2013-01-01

    Introduction An increasing number of generic alendronate formulations have become available. Although expected to have the same tolerability and efficacy, head-to head comparison of generic and brand alendronate was never performed. Therefore, we compared the tolerability and efficacy of generic and brand alendronate. Methods In a randomized double-blinded single centre cross-over study in 37 postmenopausal women (mean age 65.4±6.4 years) with osteoporosis were treated with generic and branded alendronate during 24 (2x12) weeks. Tolerance was evaluated by the Gastro intestinal Symptom Rating Scale (GSRS) and self-reported side effects. Efficacy was assessed by serum bone turnover markers, carboxy terminal telopeptide (CTX) and procollagen type I N-terminal propeptide (PINP). No wash out period was allowed (ethical reasons). Because of possible carry over effect only data of the first 12 weeks were analyzed using linear mixed models. Results There were no significant differences in overall tolerance (GSRS) between treatment groups. However, for subscale abdominal pain, patients using generic had a significantly higher mean GSRS score at week 4 (estimated mean difference (B): 0.40; 95%CI: 0.05 to 0.74, p = 0.024). The level of bone turnover markers significantly decreased over 12 weeks of follow-up for generic and branded alendronate (p < 0.001). Mean level of CTX was significantly lower with branded at week 4 (B: 121.3; 95%CI: 52.0 to 190.5), but not at week 12 (B: 53.6; 95%CI:-3.7 to 110.9). No significant differences were found for PINP at week 4 or 12. Conclusions Bone turnover markers were significantly reduced with branded and generic alendronate. With branded, CTX was significantly lower at 4 weeks. Generic caused significantly higher abdominal pain scores in the first 4 weeks of treatment. Therefore, generic alendronate may not have the same tolerability and efficacy as branded alendronate in the first weeks after starting treatment in patients with a recent

  4. Expectations predict chronic pain treatment outcomes.

    PubMed

    Cormier, Stéphanie; Lavigne, Geneviève L; Choinière, Manon; Rainville, Pierre

    2016-02-01

    Accumulating evidence suggests an association between patient pretreatment expectations and numerous health outcomes. However, it remains unclear if and how expectations relate to outcomes after treatments in multidisciplinary pain programs. The present study aims at investigating the predictive association between expectations and clinical outcomes in a large database of chronic pain patients. In this observational cohort study, participants were 2272 patients treated in one of 3 university-affiliated multidisciplinary pain treatment centers. All patients received personalized care, including medical, psychological, and/or physical interventions. Patient expectations regarding pain relief and improvements in quality of life and functioning were measured before the first visit to the pain centers and served as predictor variables. Changes in pain intensity, depressive symptoms, pain interference, and tendency to catastrophize, as well as satisfaction with pain treatment and global impressions of change at 6-month follow-up, were considered as treatment outcomes. Structural equation modeling analyses showed significant positive relationships between expectations and most clinical outcomes, and this association was largely mediated by patients' global impressions of change. Similar patterns of relationships between variables were also observed in various subgroups of patients based on sex, age, pain duration, and pain classification. Such results emphasize the relevance of patient expectations as a determinant of outcomes in multimodal pain treatment programs. Furthermore, the results suggest that superior clinical outcomes are observed in individuals who expect high positive outcomes as a result of treatment.

  5. Alendronate decreases orthotopic PC-3 prostate tumor growth and metastasis to prostate-draining lymph nodes in nude mice

    PubMed Central

    Tuomela, Johanna M; Valta, Maija P; Väänänen, Kalervo; Härkönen, Pirkko L

    2008-01-01

    Background Metastatic prostate cancer is associated with a high morbidity and mortality but the spreading mechanisms are still poorly understood. The aminobisphosphonate alendronate, used to reduce bone loss, has also been shown to inhibit the invasion and migration of prostate cancer cells in vitro. We used a modified orthotopic PC-3 nude mouse tumor model of human prostate cancer to study whether alendronate affects prostate tumor growth and metastasis. Methods PC-3 cells (5 × 105) were implanted in the prostates of nude mice and the mice were treated with alendronate (0.5 mg/kg/day in PBS, s.c.) or vehicle for 4 weeks. After sacrifice, the sizes of tumor-bearing prostates were measured and the tumors and prostate-draining regional iliac and sacral lymph nodes were excised for studies on markers of proliferation, apoptosis, angiogenesis and lymphangiogenesis, using histomorphometry and immunohistochemistry. Results Tumor occurrence in the prostate was 73% in the alendronate-treated group and 81% in the control group. Mean tumor size (218 mm3, range: 96–485 mm3, n = 11) in the alendronate-treated mice was 41% of that in the control mice (513 mm3, range: 209–1350 mm3, n = 13) (p < 0.05). In the iliac and sacral lymph nodes of alendronate-treated mice, the proportion of metastatic area was only about 10% of that in control mice (p < 0.001). Immunohistochemical staining of tumor sections showed that alendronate treatment caused a marked decrease in the number of CD34-positive endothelial cells in tumors (p < 0.001) and an increase in that of ISEL positive apoptotic cells in tumors as well as in lymph node metastases (p < 0.05) compared with those in the vehicle-treated mice. The density of m-LYVE-1-stained lymphatic capillaries was not changed. Conclusion Our results demonstrate that alendronate treatment opposes growth of orthotopic PC-3 tumors and decreases tumor metastasis to prostate-draining lymph nodes. This effect could be at least partly explained by

  6. Alendronate-eluting polyglucose-lignol composite (POGLICO)

    PubMed Central

    Aspenberg, Per

    2014-01-01

    Background and purpose — Due to the known drawbacks of metal implants, new biomaterials for internal fracture fixation are attracting increasing interest, among them poly(lactic-co-glucolic) acids (PLGAs) and the recently developed silk-tenoin derived materials (STDMs). In accordance with the new philosophy of bio-derived biomaterials (BIODERIBIOs), I describe a novel innovative technology for use in fracture fixation. Patients and methods — Screws (2 mm dia.) were manufactured from cylindrical bars of polyglucose-lignol composite (POGLICO) in the form of birch toothpicks from the hospital canteen, dip-coated with alendronate (1 mg/mL, n = 6) or saline (n = 6), and inserted in the proximal tibias of rats for 4 weeks. Fixation was evaluated by mechanical pullout testing. POGLICO nails were inserted in the contralateral tibia for microCT and histology. Results — All POGLICO implants remained fixed in the bone (p < 0.001) with a mean pullout force of 37 (SD 5.5) N. MicroCT showed that the control nails were surrounded by a thin layer of new bone, while all bisphosphonate-treated implants were surrounded by a thick layer of cancellous bone. Bisphosphonates more than doubled the bone density around the nails (p = 0.004). Interpretation — POGLICO is biocompatible, remains in situ, and appears to provide a higher resistance to pullout forces than bulk silk protein. The material is light, strong, and bio-derived. BIODERIBIO-POGLICO can be sterilized by autoclaving, and has a porous surface that can serve for slow release of drugs applied by simple dip-coating, as demonstrated by the effect of the alendronate treatment. As the raw material for the screws is readily available from the toothpick industry, I believe that the possibilities for commercial development of the material for fracture fixation are promising. PMID:25350611

  7. Suppression of CYP2B Induction by Alendronate-Mediated Farnesyl Diphosphate Synthase Inhibition in Primary Cultured Rat Hepatocytes

    PubMed Central

    Jackson, Nancy M.; Kocarek, Thomas A.

    2008-01-01

    We previously reported that squalestatin 1-mediated induction of CYP2B expression is attributable to squalene synthase inhibition and accumulation of an endogenous isoprenoid(s) that is capable of activating the constitutive androstane receptor. To determine whether squalestatin 1-mediated CYP2B induction is strictly dependent upon the biosynthesis of farnesyl pyrophosphate (FPP), the substrate for squalene synthase, the effects of alendronate, a nitrogen-containing bisphosphonate inhibitor of farnesyl diphosphate synthase, were determined on basal, squalestatin 1-inducible, and phenobarbital-inducible CYP2B expression in primary cultured rat hepatocytes. Alendronate treatment alone had no effect on CYP2B or CYP3A mRNA expression in the hepatocyte cultures, but alendronate co-treatment completely suppressed squalestatin 1-mediated CYP2B mRNA induction at concentrations (60 and 100 μM) that effectively inhibited cellular farnesyl diphosphate synthase activity, as assessed by reductions of squalestatin 1-mediated FPP accumulation, and that were not toxic to the cells, as indicated by a lack of effect on MTT activity. Alendronate co-treatment also partially suppressed phenobarbital-inducible CYP2B expression, and this suppressive effect was attenuated by additional co-treatment with the upstream pathway inhibitor, pravastatin. These findings demonstrate that squalestatin 1-mediated CYP2B induction cannot occur in the absence of FPP biosynthesis, but also indicate that one or more upstream isoprenoids, possibly isopentenyl pyrophosphate and/or dimethylallyl pyrophosphate, function to antagonize the CYP2B induction process. PMID:18617600

  8. Alendronate-associated osteonecrosis of the jaws: A review of the main topics

    PubMed Central

    Paiva-Fonseca, Felipe; Santos-Silva, Alan R.; Della-Coletta, Ricardo; Vargas, Pablo A.

    2014-01-01

    Bisphosphonates is a group of inorganic pyrophosphates analogues that suppress bone resorption by inducing osteoclast inactivation, being frequently used for management of diseases affecting bone metabolism, bone metastases and bone tumors. However, since 2003 many cases describing the presence of necrotic bone exposures in the jaws have been described in patients receiving these drugs, what represent a significant complication of bisphosphonates treatment. The overall incidence of bisphosphonate-related osteonecrosis of the jaws is low, ranging from 0.7% to 12%, mainly observed in those patients receiving intravenously treatment. Osteonecrosis of the jaws associated to oral bisphosphonate, particularly alendronate, has also been reported by a number of authors. Considering that alendronate is one of the most used drugs worldwide, specially for treatment of osteoporosis, a better understanding of osteonecrosis of the jaws related to its use and how to manage these patients is extremely important. Therefore, in the current manuscript the authors aim to review the most important topics related to this pathological presentation. Key words:Bisphosphonates, alendronate, bisphosphonate-related osteonecrosis of the jaws, osteonecrosis. PMID:23986020

  9. Client outcomes from rural substance abuse treatment.

    PubMed

    Hiller, Matthew L; Leukefeld, Carl G; Garrity, Thomas F; Godlaski, Theodore; Schoeneberger, Marlies; Townsend, Michael; Hascal, Karyn

    2007-03-01

    Several national evaluations have been conducted since the late 1960s that have assessed the effectiveness of publicly-funded substance abuse treatment in the United States. These studies, however, have focused principally on urban-based treatment programs, and it is unclear whether findings from urban programs can be replicated in outcome studies of programs in rural areas. The current study, therefore, examined the treatment outcomes of clients admitted to one of several short-term inpatient or outpatient drug-free treatment agencies in rural Kentucky. Findings showed that treatment was associated with reductions in drug use and criminality during a six-month follow-up interval. Employment status also improved significantly, and health services utilization was reduced. The similarity between the current findings and findings from national outcome studies of urban-based treatment programs is discussed.

  10. Effects of Teriparatide, Alendronate, or Both in Women with Postmenopausal Osteoporosis

    PubMed Central

    Finkelstein, Joel S.; Wyland, Jason J.; Lee, Hang; Neer, Robert M.

    2010-01-01

    Context: Teriparatide increases both bone formation and bone resorption. Objective: We sought to determine whether combining teriparatide with an antiresorptive agent would alter its anabolic action. Design and Setting: This was a randomized controlled trial conducted in a single university hospital. Patients and Intervention: We randomized 93 postmenopausal women with low bone mineral density (BMD) to alendronate 10 mg daily (group 1), teriparatide 40 μg sc daily (group 2), or both (group 3) for 30 months. Teriparatide was begun at month 6. Main Outcome Measures: BMD of the lumbar spine, proximal femur, proximal radius, and total body was measured by dual-energy x-ray absorptiometry (DXA) every 6 months. Lumbar spine trabecular BMD was measured at baseline and month 30 by quantitative computed tomography. Serum osteocalcin, N-terminal propeptide of type 1 collagen, and N-telopeptide levels were assessed frequently. Women who had at least one repeat DXA scan on therapy were included in the analyses (n = 69). Results: DXA spine BMD increased more in women treated with teriparatide alone than with alendronate alone (18 ± 11 vs. 7 ± 4%; P < 0.001) or both (18±11 vs. 12 ± 9%; P = 0.045). Similarly, femoral neck BMD increased more in women treated with teriparatide alone than with alendronate alone (11 ± 5 vs. 4 ± 4%; P < 0.001) or both (11 ± 5 vs. 3 ± 5%; P < 0.001). Quantitative computed tomography spine BMD increased 1 ± 7, 61 ± 31, and 24 ± 24% in groups 1, 2, and 3 (P < 0.001 for all comparisons). Serum osteocalcin, N-terminal propeptide of type 1 collagen, and cross-linked N-telopeptides of type I collagen increased more with teriparatide alone than with both (P < 0.001 for each marker). Conclusion: Alendronate reduces the ability of teriparatide to increase BMD and bone turnover in women. PMID:20164296

  11. Outcome Prediction in Clinical Treatment Processes.

    PubMed

    Huang, Zhengxing; Dong, Wei; Ji, Lei; Duan, Huilong

    2016-01-01

    Clinical outcome prediction, as strong implications for health service delivery of clinical treatment processes (CTPs), is important for both patients and healthcare providers. Prior studies typically use a priori knowledge, such as demographics or patient physical factors, to estimate clinical outcomes at early stages of CTPs (e.g., admission). They lack the ability to deal with temporal evolution of CTPs. In addition, most of the existing studies employ data mining or machine learning methods to generate a prediction model for a specific type of clinical outcome, however, a mathematical model that predicts multiple clinical outcomes simultaneously, has not yet been established. In this study, a hybrid approach is proposed to provide a continuous predictive monitoring service on multiple clinical outcomes. More specifically, a probabilistic topic model is applied to discover underlying treatment patterns of CTPs from electronic medical records. Then, the learned treatment patterns, as low-dimensional features of CTPs, are exploited for clinical outcome prediction across various stages of CTPs based on multi-label classification. The proposal is evaluated to predict three typical classes of clinical outcomes, i.e., length of stay, readmission time, and the type of discharge, using 3492 pieces of patients' medical records of the unstable angina CTP, extracted from a Chinese hospital. The stable model was characterized by 84.9% accuracy and 6.4% hamming-loss with 3 latent treatment patterns discovered from data, which outperforms the benchmark multi-label classification algorithms for clinical outcome prediction. Our study indicates the proposed approach can potentially improve the quality of clinical outcome prediction, and assist physicians to understand the patient conditions, treatment inventions, and clinical outcomes in an integrated view.

  12. Cost-minimization study comparing annual infusion of zoledronic acid or weekly oral alendronate in women with low bone mineral density.

    PubMed

    Chávez-Valencia, Venice; Arce-Salinas, César Alejandro; Espinosa-Ortega, Fabricio

    2014-01-01

    Cost-minimization study to assess the annual direct costs of 2 antiresorptive strategies in postmenopausal women with low bone mineral densities (BMDs). Patients were randomly assigned to receive 70 mg of oral weekly alendronate or a 1-time 5mg of intravenous zoledronic acid. All medical and nonmedical direct costs were recorded for 1 yr. Student's t-test or the Chi-squared test was used. A total of 101 postmenopausal women were enrolled with a mean age of 58.3 ± 7.6 yr and a postmenopausal period of 13.5 ± 8.3 yr. A total of 50 patients completed 1 yr of alendronate and 51 patients received zoledronic acid. At baseline, no differences were seen between the 2 groups in anthropometric measures, comorbidities, and bone mineral density. The costs for medical attention for low bone mass were $81,532 (US Dollars) for the alendronate group and $69,251 for the zoledronic acid group; the cost per patient was $1631 in the alendronate group vs $1358 in the zoledronic acid group (p<0.0001). Therefore, zoledronic acid treatment provided an annual savings of 15% of the direct costs compared with oral alendronate treatment. Moreover, there was a significant increase in lumbar spine T-scores in the zoledronic acid group when compared with the alendronate group. Annual zoledronic acid infusion as an antiresorptive treatment in women with low BMD provides significant monetary savings when compared with weekly alendronate therapy for 1 yr. Zoledronic acid infusion is also linked to higher increase in BMD and compliance.

  13. Alendronate, a double-edged sword acting in the mevalonate pathway

    PubMed Central

    TRICARICO, PAOLA MAURA; GIRARDELLI, MARTINA; KLEINER, GIULIO; KNOWLES, ALESSANDRA; VALENCIC, ERICA; CROVELLA, SERGIO; MARCUZZI, ANNALISA

    2015-01-01

    Aminobisphosphonate aledronate is a compound commonly used clinically for the treatment of osteoporosis and other bone diseases, as a result of it preventing bone resorption. However, in previous years it has also been used to obtain cellular and animal models of a rare genetic disorder termed Mevalonate Kinase Deficiency (MKD). MKD is caused by mutations affecting the mevalonate kinase enzyme, in the cholesterol pathway and alendronate can be used to biochemically mimic the genetic defect as it inhibits farnesyl pyrophosphate synthase in the same pathway. Despite evidence in favor of the inhibition exerted on the mevalonate pathway, there is at least one clinical case of MKD in which alendronate improved not only skeletal and bone fractures, as expected, but also MKD clinical features. Based on this finding, the present study assessed the anti-inflammatory properties of this aminobisphosphonate in vitro. No anti-inflammatory effects of alendronate were observed in the in vitro experiments. Since MKD lacks specific treatments, these results may assist scientists and physicians in making the decision as to the most suitable choice of therapeutic compounds for this neglected disease. PMID:26096667

  14. Alendronate, a double-edged sword acting in the mevalonate pathway.

    PubMed

    Tricarico, Paola Maura; Girardelli, Martina; Kleiner, Giulio; Knowles, Alessandra; Valencic, Erica; Crovella, Sergio; Marcuzzi, Annalisa

    2015-09-01

    Aminobisphosphonate aledronate is a compound commonly used clinically for the treatment of osteoporosis and other bone diseases, as a result of it preventing bone resorption. However, in previous years it has also been used to obtain cellular and animal models of a rare genetic disorder termed Mevalonate Kinase Deficiency (MKD). MKD is caused by mutations affecting the mevalonate kinase enzyme, in the cholesterol pathway and alendronate can be used to biochemically mimic the genetic defect as it inhibits farnesyl pyrophosphate synthase in the same pathway. Despite evidence in favor of the inhibition exerted on the mevalonate pathway, there is at least one clinical case of MKD in which alendronate improved not only skeletal and bone fractures, as expected, but also MKD clinical features. Based on this finding, the present study assessed the anti‑inflammatory properties of this aminobisphosphonate in vitro. No anti‑inflammatory effects of alendronate were observed in the in vitro experiments. Since MKD lacks specific treatments, these results may assist scientists and physicians in making the decision as to the most suitable choice of therapeutic compounds for this neglected disease.

  15. Alendronate inhalation ameliorates elastase-induced pulmonary emphysema in mice by induction of apoptosis of alveolar macrophages.

    PubMed

    Ueno, Manabu; Maeno, Toshitaka; Nishimura, Satoshi; Ogata, Fusa; Masubuchi, Hiroaki; Hara, Kenichiro; Yamaguchi, Kouichi; Aoki, Fumiaki; Suga, Tatsuo; Nagai, Ryozo; Kurabayashi, Masahiko

    2015-03-10

    Alveolar macrophages play a crucial role in the pathogenesis of emphysema, for which there is currently no effective treatment. Bisphosphonates are widely used to treat osteoclast-mediated bone diseases. Here we show that delivery of the nitrogen-containing bisphosphonate alendronate via aerosol inhalation ameliorates elastase-induced emphysema in mice. Inhaled, but not orally ingested, alendronate inhibits airspace enlargement after elastase instillation, and induces apoptosis of macrophages in bronchoalveolar fluid via caspase-3- and mevalonate-dependent pathways. Cytometric analysis indicates that the F4/80(+)CD11b(high)CD11c(mild) population characterizing inflammatory macrophages, and the F4/80(+)CD11b(mild)CD11c(high) population defining resident alveolar macrophages take up substantial amounts of the bisphosphonate imaging agent OsteoSense680 after aerosol inhalation. We further show that alendronate inhibits macrophage migratory and phagocytotic activities and blunts the inflammatory response of alveolar macrophages by inhibiting nuclear factor-κB signalling. Given that the alendronate inhalation effectively induces apoptosis in both recruited and resident alveolar macrophages, we suggest this strategy may have therapeutic potential for the treatment of emphysema.

  16. Alendronate augments interleukin-1{beta} release from macrophages infected with periodontal pathogenic bacteria through activation of caspase-1

    SciTech Connect

    Deng Xue; Tamai, Riyoko; Endo, Yasuo; Kiyoura, Yusuke

    2009-02-15

    Nitrogen-containing bisphosphonates (NBPs) are anti-bone-resorptive drugs with inflammatory side effects that include osteomyelitis and osteonecrosis of the jaw. Oral bacteria have been considered to be a trigger for these NBP-associated jaw bone diseases. The present study examined the effects of alendronate (a typical NBP) and clodronate (a non-NBP) on the production of proinflammatory cytokines by macrophages infected with Porphyromonas gingivalis and Tannerella forsythia, which are important pathogens of periodontal diseases. Pretreatment with alendronate augmented IL-1{beta}, but not TNF{alpha}, production by macrophages infected with P. gingivalis or T. forsythia. This augmentation of IL-1{beta} production was inhibited by clodronate. Furthermore, caspase-1, a promoter of IL-1{beta} production, was activated by treatment with alendronate, and caspase-1 inhibitor reduced the production of IL-1{beta} induced by alendronate and P. gingivalis. These results suggest that NBPs augment periodontal pathogenic bacteria-induced IL-1{beta} release via caspase-1 activation, and this phenomenon may contribute to the development of NBP-associated inflammatory side effects including jaw osteomyelitis. Co-treatment with clodronate may prevent and/or reduce these inflammatory effects induced by NBPs.

  17. Comparison of the alendronate and irradiation with a light-emitting diode (LED) on murine osteoclastogenesis.

    PubMed

    Sohn, Hong Moon; Ko, Youngjong; Park, Mineon; Kim, Bora; Park, Jung Eun; Kim, Donghwi; Moon, Young Lae; Lim, Wonbong

    2017-01-01

    Photomodulation therapy (PBMT) using light-emitting diode (LED) has been proposed as an alternative to conventional osteoporosis therapies. Our aim was to determine the effect of irradiation with a light-emitting diode on receptor activator of NF-κB ligand (RANKL)-mediated differentiation of mouse bone marrow macrophages into osteoclasts and compare it to alendronate treatment. The cells were irradiated with LED at 635±10 nm, 9-cm spot size, 5 mW/cm(2), and 18 J for 60 min/day in a CO2 incubator. The differentiation of irradiated and untreated RANKL-stimulated bone marrow macrophages into osteoclasts was evaluated by tartrate-resistant acid phosphatase (TRAP) staining and by molecular methods. These included assessing messenger RNA (mRNA) expression of osteoclastic markers such as TRAP, c-Fos, Atp6v0d2, DC-STAMP, NFATc1, cathepsin K, MMP9 and OSCAR; phosphorylation of various MAPKs, including extracellular signal-regulated kinase ERK1/2, P38, and JNK; NF-κB translocation; and resorption pit formation. Results were compared to those obtained with sodium alendronate. Production of reactive oxygen species was measured by a 2',7'-dihydrodichlorofluorescein diacetate assay. LED irradiation and alendronate inhibited mRNA expression of osteoclast-related genes, such as TRAP, c-Fos, and NFATc1, and reduced the osteoclast activity of RANKL-stimulated bone marrow macrophages. LED irradiation, but not alendronate, also inhibited the production of reactive oxygen species (ROS); phosphorylation of ERK, P38, and IκB; and NF-κB translocation. These findings suggest that LED irradiation downregulates osteoclastogenesis by ROS production; this effect could lead to reduced bone loss and may offer a new therapeutic tool for managing osteoporosis.

  18. Hydroxyapatite nanocrystals functionalized with alendronate as bioactive components for bone implant coatings to decrease osteoclastic activity

    NASA Astrophysics Data System (ADS)

    Bosco, Ruggero; Iafisco, Michele; Tampieri, Anna; Jansen, John A.; Leeuwenburgh, Sander C. G.; van den Beucken, Jeroen J. J. P.

    2015-02-01

    The integration of bone implants within native bone tissue depends on periprosthetic bone quality, which is severely decreased in osteoporotic patients. In this work, we have synthesized bone-like hydroxyapatite nanocrystals (nHA) using an acid-base neutralization reaction and analysed their physicochemical properties. Subsequently, we have functionalized the nHA with alendronate (nHAALE), a well-known bisphosphonate drug used for the treatment of osteoporosis. An in vitro osteoclastogenesis test was carried out to evaluate the effect of nHAALE on the formation of osteoclast-like cells from monocytic precursor cells (i.e. RAW264.7 cell line) showing that nHAALE significantly promoted apoptosis of osteoclast-like cells. Subsequently, nHA and nHAALE were deposited on titanium disks using electrospray deposition (ESD), for which characterisation of the deposited coatings confirmed the presence of alendronate in nHAALE coatings with nanoscale thickness of about 700 nm. These results indicate that alendronate linked to hydroxyapatite nanocrystals has therapeutic potential and nHAALE can be considered as an appealing coating constituent material for orthopaedic and oral implants for application in osteoporotic patients.

  19. Moyamoya Disease: Treatment and Outcomes

    PubMed Central

    Kim, Tackeun; Oh, Chang Wan; Bang, Jae Seung; Kim, Jeong Eun; Cho, Won-Sang

    2016-01-01

    Although the pathogenesis of moyamoya disease (MMD) has not been fully elucidated, the effectiveness of surgical revascularization in preventing stroke has been addressed by many studies. The main mechanism of surgical revascularization is augmenting the intracranial blood flow using an external carotid system by either direct bypass or pial synangiosis. This can improve resting cerebral blood flow as well as vascular reserve capacity. For direct revascularization, the superficial temporal artery is used as the donor artery in most cases, although the occipital artery may be used in limited cases. Usually, the cortical branch of the middle cerebral artery is selected as the recipient of direct anastomosis. As for indirect revascularization, various techniques using different kinds of connective tissues have been introduced. In some cases, reinforcing the anterior cerebral artery and the posterior cerebral artery territories can be considered. The effectiveness of surgical revascularization for preventing ischemic stroke had been generally accepted by many studies. However, for preventing hemorrhagic stroke, new evidence has been added by a recent randomized controlled trial. The incidence of peri-operative complications such as stroke and hyperperfusion syndrome seems to be high due to the nature of the disease and technical demands for treatment. Preventing and adequately managing these complications are essential for ensuring the benefits of surgery. PMID:26846757

  20. Histomorphometrical analysis of the effects of the bisphosphonate alendronate on bone loss caused by experimental periodontitis in monkeys.

    PubMed

    Weinreb, M; Quartuccio, H; Seedor, J G; Aufdemorte, T B; Brunsvold, M; Chaves, E; Kornman, K S; Rodan, G A

    1994-01-01

    This study tested the efficacy of alendronate, a bisphosphate, in reducing alveolar bone loss caused by experimental periodontitis in cynomolgus monkeys. Periodontitis was initiated in adult monkeys by ligating mandibular molar teeth at the cementoenamel junction (CEJ) and subsequently inoculating the ligature with Porphyromonas (Bacteroides) gingivalis. Contralateral, homologous non-ligated teeth served as controls. Animals received, intravenously, either saline (placebo) or alendronate at 0.05 or 0.25 mg/kg every 2 weeks for 16 weeks. After the animals were sacrificed, coronal sections through mandibular molars were subjected to histomorphometrical analysis. No overt side-effects were observed in any of the animals participating in this study. In placebo-treated animals, ligation and inoculation resulted in significant bone loss both at the CEJ and at the furcation. Alendronate at 0.05 mg/kg significantly reduced bone loss associated with the experimental periodontitis at both sites. In contrast, the dose of 0.25 mg/kg was ineffective in attenuating alveolar bone loss in the furcation area and only slightly effective in preventing it at the CEJ area. The results of the histomorphometric analysis correlate closely with those of the radiographic analysis of the same experiment. These data indicate that alendronate could reduce the loss of alveolar support associated with periodontitis and suggest that bisphosphonates, by virtue of their significant inhibitory action on osteoclasts, may become a treatment modality in the battle against alveolar bone destruction during periodontal disease.

  1. Alendronate affects calcium dynamics in cardiomyocytes in vitro.

    PubMed

    Kemeny-Suss, Naomi; Kasneci, Amanda; Rivas, Daniel; Afilalo, Jonathan; Komarova, Svetlana V; Chalifour, Lorraine E; Duque, Gustavo

    2009-01-01

    Therapy with bisphosphonates, including alendronate (ALN), is considered a safe and effective treatment for osteoporosis. However, recent studies have reported an unexpected increase in serious atrial fibrillation (AF) in patients treated with bisphosphonates. The mechanism that explains this side effect remains unknown. Since AF is associated with an altered sarcoendoplasmic reticulum calcium load, we studied how ALN affects cardiomyocyte calcium homeostasis and protein isoprenylation in vitro. Acute and long-term (48h) treatment of atrial and ventricular cardiomyocytes with ALN (10(-8)-10(-6)M) was performed. Changes in calcium dynamics were determined by both fluorescence measurement of cytosolic free Ca(2+) concentration and western blot analysis of calcium-regulating proteins. Finally, effect of ALN on protein farnesylation was also identified. In both atrial and ventricular cardiomyocytes, ALN treatment delayed and diminished calcium responses to caffeine. Only in atrial cells, long-term exposure to ALN-induced transitory calcium oscillations and led to the development of oscillatory component in calcium responses to caffeine. Changes in calcium dynamics were accompanied by changes in expression of proteins controlling sarcoendoplasmic reticulum calcium. In contrast, ALN minimally affected protein isoprenylation in these cells. In summary, treatment of atrial cardiomyocytes with ALN-induced abnormalities in calcium dynamics consistent with induction of a self-stimulatory, pacemaker-like behavior, which may contribute to the development of cardiac side effects associated with these drugs.

  2. Osteonecrosis of the jaw induced by orally administered bisphosphonates: incidence, clinical features, predisposing factors and treatment outcome.

    PubMed

    Yarom, N; Yahalom, R; Shoshani, Y; Hamed, W; Regev, E; Elad, S

    2007-10-01

    Osteonecrosis of the jaw (ONJ) is a well-known devastating side effect of bisphosphonate therapy for cancer. Several ONJ cases of patients using oral bisphosphonates have been reported in the literature. The present study analyzed the clinical features, predisposing factors, and treatment outcome of 11 patients with oral bisphosphonates-related ONJ. Osteonecrosis of the jaw (ONJ) is a well-known side effect of parenteral bisphosphonates therapy. Although ONJ has been reported in patients using oral bisphosphonates, documentation of this entity is sparse. It was hypothesized that the clinical features, predisposing factors, and treatment outcome of this population are different from those of oncologic patients. This retrospective bi-central study involved 98 ONJ patients, 13 of whom were treated with oral bisphosphonates. Two patients were excluded because of previous use of intravenous bisphosphonates. The profiles of 11 patients were analyzed. The mean duration of alendronate use before developing ONJ was 4.1 years. ONJ was triggered by dental surgery in 9 patients and by ill-fitted dentures in 2. Heavy smokers were the most recalcitrant subjects. Among the nine patients with at least 6 months of follow-up, ONJ healed completely in three, partially in four, and not at all in two. ONJ is a rare devastating side effect of oral bisphosphonates associated with patient morbidity and high financial burden. Clinicians must be aware of this entity and inform patients of the risks of dental surgery. The synergistic effect of smoking in the pathogenesis of ONJ should be further investigated.

  3. Alendronate conjugated nanoparticles for calcification targeting.

    PubMed

    Li, Nanying; Song, Juqing; Zhu, Guanglin; Shi, Xuetao; Wang, Yingjun

    2016-06-01

    In this article, the synthesis of a novel calcification-targeting nanoparticle (NP) is reported, which is realized through dopamine self-polymerization on the poly(lactic-co-glycolic acid) (PLGA) particle surface and subsequent alendronate conjugation. Cell viability and proliferation tests confirmed that such particle has low cytotoxicity and good biocompatibility. Experiments were designed to observe whether the synthesized NPs can pass through an obstructive hydrogel and directly bind themselves to hydroxyapatite (HA) NPs (mimicking calcified spots) and HA porous scaffolds (mimicking calcified tissues); and the result was positive, indicating ingenious targeting of NPs on calcifications. The calcification-targeting NPs are expected to be with promising applications on calcification-related disease diagnoses and therapies. Copyright © 2016. Published by Elsevier B.V.

  4. Therapist Perception of Treatment Outcome: Evaluating Treatment Outcomes among Youth with Antisocial Behavior Problems

    PubMed Central

    Crandal, Brent R.; Foster, Sharon L.; Chapman, Jason E.; Cunningham, Phillippe B.; Brennan, Patricia A.; Whitmore, Elizabeth A.

    2014-01-01

    Effective evaluation of treatment requires the use of measurement tools producing reliable scores that can be used to make valid decisions about the outcomes of interest. Therapist-rated treatment outcome scores that are obtained within the context of empirically supported treatments (EST) could provide clinicians and researchers with data that are easily accessible and complimentary to existing instrumentation. We examined the psychometric properties of scores from the Therapist Perception of Treatment Outcome: Youth Antisocial Behavior (TPTO:YAB), an instrument developed to assess therapist judgments of treatment success among families participating in an EST, Multsystemic Therapy (MST), for youth with antisocial behavior problems. Data were drawn from a longitudinal study of MST. The initial 20-item TPTO was completed by therapists of 111 families at mid-treatment and 163 families at treatment termination. Rasch model dimensionality analyses provided evidence for two dimensions reflecting youth- and caregiver-related aspects of treatment outcome, although a bifactor analyses suggested that these dimensions reflected a single more general construct. Rasch analyses were also used to assess item and rating scale characteristics and refine the number of items. These analyses suggested items performed similarly across time and that scores reflect treatment outcome in similar ways at mid and post-treatment. Multilevel and zero-order analyses provided evidence for the validity of TPTO scores. TPTO scores were moderately correlated with scores of youth and caregiver behaviors targeted in treatment, adding support to its use as a treatment outcome measurement instrument. PMID:25642936

  5. Long-term treatment outcome in acromegaly.

    PubMed

    Holdaway, I M; Rajasoorya, C R; Gamble, G D; Stewart, A W

    2003-08-01

    A number of groups have developed guidelines to indicate whether an individual with acromegaly has been cured by treatment. However, studies to date do not provide a robust definition of biochemical remission of the disorder based on correlation with long-term outcome. Available data suggest that those with a random serum growth hormone (GH) level of <2.5 microg/l, or a glucose-suppressed GH level of <1 microg/l following treatment have mortality figures indistinguishable from the general population. However, the confidence limits for these mortality estimates are quite wide. It remains possible that growth hormone levels lower than 1 microg/l for random samples, or even lower when using ultrasensitive GH assays, may indicate superior outcome, but this remains to be confirmed. There are limited data relating serum insulin-like growth factor-I (IGF-I) levels to outcome, although normalisation of serum IGF-I clearly improves outcome compared with continued elevation of measurements after treatment. Current evidence suggests that a post-treatment random serum GH <2.5 microg/l and a normal serum IGF-I value defines biochemical cure. Available data suggest that achieving similar growth hormone levels after treatment also reduces the prevalence of chronic complications of the disorder, which is subsequently reflected in improved mortality.

  6. Psychosocial outcomes in active treatment through survivorship.

    PubMed

    Reed, Sarah C; Bell, Janice F; Whitney, Robin; Lash, Rebecca; Kim, Katherine K; Bold, Richard J; Joseph, Jill G

    2017-04-20

    The objective of the study is to understand potential differences in psychosocial outcomes from active treatment to survivorship. Using the Medical Expenditure Panel Survey Experiences with Cancer Survivorship Supplement (n = 1360), we examined and compared psychosocial outcomes among respondents in active treatment with survivors by year(s) since treatment ended. Survey-weighted regression models were used to test associations between year(s) since treatment and depressive symptoms (Patient Health Questionnaire-2), psychological distress (K6), and cancer-specific worry related to recurrence. Unadjusted estimates showed no significant differences in depressive symptoms or psychological distress between those in active treatment and cancer survivors at any time posttreatment. In contrast, the prevalence of cancer-specific worry was lowest among survivors more than 5 years since treatment (10%), slightly higher among those with less than 1 year since treatment (15%), and highest among those in active treatment (32%). In models controlled for sociodemographic and health-related covariates, the year(s) since treatment ended was inversely associated with the odds of cancer-specific worry but was not associated with depressive symptoms or psychological distress. In this population-based sample, worry about cancer recurrence may diminish with years since treatment ended, while depressive symptoms and distress are persistent across the trajectory. These findings highlight unmet psychosocial needs among cancer survivors and demonstrate the importance of targeted interventions across the survivorship continuum. Copyright © 2017 John Wiley & Sons, Ltd.

  7. Atypical periprosthetic acetabular fracture in long-term alendronate therapy

    PubMed Central

    Marongiu, Giuseppe; Capone, Antonio

    2016-01-01

    Summary Bisphosphonates have been commonly used in the treatment of osteoporosis, demonstrating its efficacy in fracture risk reduction. However, even if are generally safe and well tolerated, concerns have emerged about atypical fractures related to its prolonged use. Although atypical femoral fracture are more common, case reports demonstrated that even other skeletal areas can be involved by unusual pattern of fracture. We report a atypical acetabular periprosthetic fracture in a 83-year-old female patient after prolonged alendronate treatment for osteoporosis and isolated acetabular revision surgery. The patient underwent to clinical, bioumoral and radiological evaluation and all the history cases were fully reported. We believe this periprosthetic fracture, according to the available data, may have similar underlying pathology to atypical femoral fractures. Awareness of symptoms, in addition to a regular radiographic survey may facilitate early diagnosis and possible prevention of spontaneous periprosthetic fractures, in patients receiving bisphosphonate therapy beyond 5 years. The treatment of this atypical periprosthetic fracture should include both surgical than pharmacological therapy to obtained bone healing. PMID:28228784

  8. Atypical periprosthetic acetabular fracture in long-term alendronate therapy.

    PubMed

    Marongiu, Giuseppe; Capone, Antonio

    2016-01-01

    Bisphosphonates have been commonly used in the treatment of osteoporosis, demonstrating its efficacy in fracture risk reduction. However, even if are generally safe and well tolerated, concerns have emerged about atypical fractures related to its prolonged use. Although atypical femoral fracture are more common, case reports demonstrated that even other skeletal areas can be involved by unusual pattern of fracture. We report a atypical acetabular periprosthetic fracture in a 83-year-old female patient after prolonged alendronate treatment for osteoporosis and isolated acetabular revision surgery. The patient underwent to clinical, bioumoral and radiological evaluation and all the history cases were fully reported. We believe this periprosthetic fracture, according to the available data, may have similar underlying pathology to atypical femoral fractures. Awareness of symptoms, in addition to a regular radiographic survey may facilitate early diagnosis and possible prevention of spontaneous periprosthetic fractures, in patients receiving bisphosphonate therapy beyond 5 years. The treatment of this atypical periprosthetic fracture should include both surgical than pharmacological therapy to obtained bone healing.

  9. Treatment Sequence Matters: Anabolic and Antiresorptive Therapy for Osteoporosis.

    PubMed

    Cosman, Felicia; Nieves, Jeri W; Dempster, David W

    2017-02-01

    The effects of anabolic medications (teriparatide [TPTD] and parathyroid hormone [PTH]) differ in patients who have received recent treatment with potent antiresorptives. This perspective reviews studies evaluating bone density (BMD) and histomorphometric effects of treatment sequences beginning with TPTD/PTH followed by potent antiresorptives and those beginning with potent antiresorptives followed by switching to or adding TPTD. Effect of treatment sequence on spine BMD outcome is minor, with modest quantitative differences. However, when individuals established on potent bisphosphonates are switched to TPTD, hip BMD declines below baseline for at least the first 12 months after the switch to TPTD. This transient hip BMD loss is more prominent when the antiresorptive is denosumab; in this setting, hip BMD remains below baseline for almost a full 24 months. In a controlled comparison of those who switched from alendronate to TPTD versus those who added TPTD to ongoing alendronate, the effect on hip BMD was improved with combination therapy. Furthermore, hip strength improved with the addition of TPTD to ongoing alendronate, whereas it was neutral after switching from alendronate to TPTD, primarily due to the effect on cortical bone. Bone biopsy studies indicate that TPTD stimulates bone formation in patients who have not been treated previously as well as in patients on prior and ongoing bisphosphonates. Histomorphometric evidence suggests that use of alendronate with TPTD blocks the TPTD-induced increase in cortical porosity. When possible, we suggest anabolic therapy first, followed by potent antiresorptive therapy. The common practice of switching to TPTD only after patients have an inadequate response to antiresorptives (intercurrent fracture or inadequate BMD effect) is not the optimal utilization of anabolic treatment. In fact, this may result in transient loss of hip BMD and strength. In this setting, continuing a potent antiresorptive while starting TPTD

  10. Exercise interventions during cancer treatment: biopsychosocial outcomes.

    PubMed

    Courneya, K S

    2001-04-01

    More than 1.2 million Americans are diagnosed with cancer each year, and many receive intensive medical treatments. Currently, exercise is not considered a standard quality-of -life intervention for cancer patients. In this article, 11 studies are reviewed that have examined exercise interventions concurrent with cancer treatment. The key conclusion is that exercise improves a wide range of biopsychosocial outcomes in cancer patients, but much more reserch is needed.

  11. Therapist perception of treatment outcome: Evaluating treatment outcomes among youth with antisocial behavior problems.

    PubMed

    Crandal, Brent R; Foster, Sharon L; Chapman, Jason E; Cunningham, Phillippe B; Brennan, Patricia A; Whitmore, Elizabeth A

    2015-06-01

    Effective evaluation of treatment requires the use of measurement tools producing reliable scores that can be used to make valid decisions about the outcomes of interest. Therapist-rated treatment outcome scores that are obtained within the context of empirically supported treatments (ESTs) could provide clinicians and researchers with data that are easily accessible and complimentary to existing instrumentation. We examined the psychometric properties of scores from the Therapist Perception of Treatment Outcome: Youth Antisocial Behavior (TPTO:YAB), an instrument developed to assess therapist judgments of treatment success among families participating in an EST, Multisystemic Therapy (MST), for youth with antisocial behavior problems. Data were drawn from a longitudinal study of MST. The initial 20-item TPTO:YAB was completed by therapists of 111 families at midtreatment and 163 families at treatment termination. Rasch model dimensionality analyses provided evidence for 2 dimensions reflecting youth- and caregiver-related aspects of treatment outcome, although a bifactor analyses suggested that these dimensions reflected a single more general construct. Rasch analyses were also used to assess item and rating scale characteristics and refine the number of items. These analyses suggested items performed similarly across time and that scores reflect treatment outcome in similar ways at mid and posttreatment. Multilevel and zero-order analyses provided evidence for the validity of TPTO:YAB scores. TPTO:YAB scores were moderately correlated with scores of youth and caregiver behaviors targeted in treatment, adding support to its use as a treatment outcome measurement instrument.

  12. What Are Some Common Outcomes of Stroke and Some Common Treatments for These Outcomes?

    MedlinePlus

    ... and Publications What are some common outcomes of stroke & some common treatments for these outcomes? Skip sharing ... and temperature changes Depression Types of Treatment for Stroke Stroke treatment includes: Emergency treatment Preventing another stroke ...

  13. Outcomes of ablative fractional laser scar treatment.

    PubMed

    Kim, Deok-Woo; Hwang, Na-Hyun; Yoon, Eul-Sik; Dhong, Eun-Sang; Park, Seung-Ha

    2015-04-01

    Ablative fractional laser (AFL) systems are commonly used to treat various scars, and recent reports have indicated that early scar treatment with fractional lasers has good aesthetic results. Some scars respond dramatically to AFL treatment, incurring high levels of patient satisfaction; however, other scars respond poorly or became worse after treatment. This study was designed to clarify prognostic factors that predict AFL scar treatment outcomes. A total of 108 patients were included in this study. The fractional laser treatments were repeated every 4 weeks until the scar site was acceptable and no additional improvement was expected or the patient discontinued the treatment. The scar improvements were defined as changes in the Manchester scar scale (MSS) from before to after laser treatment. A digital camera was used to acquire digital photographs of the scars under the same light source, the same background, exposure, and white balance. This study developed a modification of the MSS for image analysis in which colour assessment was based on L*a*b* colour co-ordinates of the digital images. The mean MSS values prior to and after laser treatments were 11.6 ± 3.6 and 9.5 ± 2.9, respectively (p < 0.01). AFL treatment improved the qualities of each scar, and the improvements were evident in colour and contour. Scar elevation, pigmentation, high vascularity, early onset of treatment, and the number of treatment sessions were directly related to scar improvement after AFL therapy (p < 0.05). AFL treatments were effective methods for scar treatment. Clinicians can use these prognostic factors to determine treatment plans and to estimate scar improvement after AFL treatment.

  14. Maternal buprenorphine treatment and infant outcome.

    PubMed

    Jansson, Lauren M; Velez, Martha L; McConnell, Krystle; Spencer, Nancy; Tuten, Michelle; Jones, Hendree; Rios, Rebeca; King, Van L; Gandotra, Neeraj; Millio, Lorraine; DiPietro, Janet A

    2017-08-31

    Maternal buprenorphine maintenance predisposes the infant to exhibit neonatal abstinence syndrome (NAS), but there is insufficient published information regarding the nature of NAS and factors that contribute to its severity in buprenorphine-exposed infants. The present study evaluated forty-one infants of buprenorphine-maintained women in comprehensive substance use disorder treatment who participated in an open-label study examining the effects of maternal buprenorphine maintenance on infant outcomes. Modifiers of the infant outcomes, including maternal treatment and substance use disorder parameters, were also evaluated. Fifty-nine percent of offspring exhibited NAS that required pharmacologic management. Both maternal buprenorphine dose as well as prenatal polysubstance exposure to illicit substance use/licit substance misuse were independently associated with NAS expression. Polysubstance exposure was associated with more severe NAS expression after controlling for the effects of buprenorphine dose. Other exposures, including cigarette smoking and SRI use, were not related to outcomes. Maternal buprenorphine dose was positively associated with lower birth weight and length. Polysubstance exposure was the most potent predictor of NAS severity in this sample of buprenorphine-exposed neonates. This finding suggests the need for interventions that reduce maternal polysubstance use during medication assisted treatment for opioid use disorder, and highlights the necessity of a comprehensive approach, beyond buprenorphine treatment alone, for the optimal care for pregnant women with opioid use disorders. Copyright © 2017. Published by Elsevier B.V.

  15. Comparison of local and systemic alendronate on distraction osteogenesis.

    PubMed

    Küçük, Dervişhan; Ay, Sinan; Kara, M Isa; Avunduk, M Cihat; Gümus, Cesur

    2011-12-01

    This study compared the effect of systemic and local administration of alendronate on distraction osteogenesis in rabbit mandibles. Thirty New Zealand white rabbits were allocated to 3 groups: 10 rabbits for systemic alendronate; 9 for local alendronate; and 11 as controls. After a 5 day latency period, distraction was performed at a rate of 0.8mm/day for 9 days via a custom-made distractor. Animals were killed at the end of the consolidation period of 28 days. The distracted mandibles were harvested and evaluated by plain radiography, computed tomography (CT), dual energy X-ray absorptiometry (DEXA), and histomorphometry. Histologically, comparing the systemic and local alendronate groups, there were no statistically significant differences in the bone healing parameters, but each group showed a statistically superior effect over the control group (p<0.05). Quantitative CT evaluation showed a significant difference mean in the density of the regeneration between experimental and control groups. There was a significant increase in mean bone mineral density in the experimental groups compared with the control group. Histologic, CT, and DEXA analysis demonstrated that using systemic and local alendronate may be effective in accelerating new bone formation in the distraction gap in rabbit mandibles. Copyright © 2011 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  16. Development of the Treatment Outcomes Profile.

    PubMed

    Marsden, John; Farrell, Michael; Bradbury, Colin; Dale-Perera, Annette; Eastwood, Brian; Roxburgh, Malcolm; Taylor, Steve

    2008-09-01

    To develop the Treatment Outcomes Profile (TOP), a new instrument for monitoring substance misuse treatment. Prospective cohort, psychometric evaluation with 7-day retest and 1-month follow-up to assess inter-rater reliability, concurrent, discriminant and construct validity, and change sensitivity. A sample of 1021 service users, aged 16-62 years. Recruitment from 63 treatment agencies in England, collectively providing opioid substitution treatment, psychosocial interventions, in-patient detoxification and residential rehabilitation. Thirty-eight frequency, rating scale and period prevalence measures, with 28-day recall, across substance use, health, crime and social functioning domains, administered as personal interview by 163 treatment keyworkers. Twenty outcome measures met inter-rater reliability criteria: days used alcohol, opioids, crack cocaine, cocaine powder, amphetamines, cannabis and one other named substance; days injected and period prevalence of direct or indirect needle/syringe sharing; subjective rating of physical and psychological health; days committed shop theft and drug selling, period prevalence of vehicle, property, fraud/forgery and assault/violence offences; rating of quality of life; days worked and attended for education/training; and period prevalence of acute housing problems and risk of eviction. Intraclass correlation coefficients for scale measures and Cohen's kappa for dichotomous measures reached or exceeded 0.75 and 0.61, respectively. There were satisfactory validity assessments and change sensitivity of scale items judged by effect size and smallest detectable difference. The TOP clinical tool contains an additional 10 items for individual treatment planning and review. The TOP is a reliable and valid 20-item instrument for treatment outcomes monitoring.

  17. Neonatal Abstinence Syndrome: Treatment and Pediatric Outcomes

    PubMed Central

    Logan, Beth A.; Brown, Mark S.; Hayes, Marie J.

    2013-01-01

    Recent rise in rates of opiate replacement therapy among pregnant women have resulted in increasing number of infants requiring treatment for neonatal abstinence syndrome. Short- and long-term developmental outcomes associated with prenatal opiate exposure are discussed, including symptoms and severity of neonatal abstinence syndrome (NAS), and early cognitive and motor delays. Maternal and infant risk factors are discussed, and include patterns of maternal substance use during pregnancy, genetic risk, polysubstance exposure pharmacologic treatment for NAS and breastfeeding. The importance of characterizing corollary environmental risk factors is also considered. PMID:23314720

  18. Neonatal abstinence syndrome: treatment and pediatric outcomes.

    PubMed

    Logan, Beth A; Brown, Mark S; Hayes, Marie J

    2013-03-01

    Recent rise in rates of opiate replacement therapy among pregnant women have resulted in increasing number of infants requiring treatment for neonatal abstinence syndrome (NAS). Short-term and long-term developmental outcomes associated with prenatal opiate exposure are discussed, including symptoms and severity of NAS, and early cognitive and motor delays. Maternal and infant risk factors are discussed, and include patterns of maternal substance use during pregnancy, genetic risk, polysubstance exposure pharmacological treatment for NAS and breastfeeding. The importance of characterizing corollary environmental risk factors is also considered.

  19. Measuring Treatment Outcomes in Women With Vulvodynia

    PubMed Central

    Ventolini, Gary

    2011-01-01

    Vulvodynia or vulvar pain syndrome is a chronic, heterogeneous, and multifactorial gynecological condition with an estimated prevalence of 9 - 12%, broad and substantial effect on quality of life due to physical disabilities, psychological distress and sexual dysfunction. A rationale therapeutic approach for the treatment of vulvodynia is still under investigation. A review of treatment modalities proposed by most of the clinicians involved in managing these patients advocated initially utilizing non-invasive therapies and then to proceed gradually to more aggressive therapies. A multidisciplinary approach that includes behavioral science and neuroimaging is required and recommended. Additionally a team approach should be utilized to test and evaluate therapies including pelvic floor physiotheraphy, psychotherapy, microbiology and pharmacology. It is my hope that this review will assist in the understanding of vulvodynia and its measuring treatment outcomes and will provide a thrust in the right direction to once and for all clarify this complex multifactorial disorder affecting women. Keywords Treatment; Vulvodynia; Women PMID:21811531

  20. Sequential administration of alendronate and strontium ranelate: histomorphometry and bone biomechanics in ovariectomized animals.

    PubMed

    Díaz, Diego H; Rodas, Julieta A; Bozzini, Clarisa E; Mandalunis, Patricia M; Escudero, Natalia D

    2016-09-01

    Bisphosphonates are the first choice therapy for the pharmaco logical treatment of osteoporosis. Following reports of cases of bisphosphonaterelated osteonecrosis of the jaw and atypical femur fracture, the safety of longterm use of bisphosphonates has been evaluated, resulting in the proposal of strontium as an alternative drug. No experimental study using a sequential administration design has been reported to date. Hence, the aim of this study was to evaluate the effect on bone tissue of ovariectomized rats of administration of alendronate followed by strontium ranelate. Fortyeight female Wistar rats were ovariectomized on day 1 of the experiment. Beginning on day 30, they were administered 0.3 mg/kg/week of alendronate (ALN) or vehicle (VEH) for 8 weeks. Two groups (ALN and corresponding control) were euthanized at this time, and the remaining animals were divided into 4 groups and given 290 mg/kg/day of strontium ranelate (SR) in their drinking water (TW) or only water for 4 months. Experimental groups were: ALN+SR, ALN+TW, VEH+SR, VEH+TW, ALN and VEH. The tibiae and hemimandibles were resected for histomorphometric evaluation, and the right femur was used to perform biomechanical studies. ANOVA and Bonferroni test were applied. Diaphyseal stiffness, maximum elastic load and fracture load increased in animals that received alendronate, regardless of whether or not they received subsequent SR treatment. Fracture load also increased in VEH+ SR versus control (VEH+TW). Subchondral and interradicular bone volumes were significantly higher in animals that received ALN than in those that received vehicle. No difference was observed in cortical area or thickness of the tibia among treatments. The results obtained with the model presented here, evaluating tibial and mandibular interradicular bone, showed that the combination of ALN and SR and administration of ALN alone are equally effective in preventing bone loss associated with ovariectomyinduced estrogen depletion.

  1. Biocompatibility evaluation of alendronate paste in rat's subcutaneous tissue.

    PubMed

    Mori, Graziela Garrido; de Moraes, Ivaldo Gomes; Nunes, Daniele Clapes; Castilho, Lithiene Ribeiro; Poi, Wilson Roberto; Capaldi, Maria Luciana P Manzoli

    2009-04-01

    Alendronate is a known inhibitor of root resorption and the development of alendronate paste would enhance its utilization as intracanal medication. Therefore, this study aimed to investigate the biocompatibility of experimental alendronate paste in subcutaneous tissue of rats, for utilization in teeth susceptible to root resorption. The study was conducted on 15 male rats, weighing approximately 180-200 grams. The rats' dorsal regions were submitted to one incision on the median region and, laterally to the incision, the subcutaneous tissue was raised and gently dissected for introduction of two tubes, in each rat. The tubes were sealed at one end with gutta-percha and taken as control. The tubes were filled with experimental alendronate paste. The animals were killed at 7, 15 and 45 days after surgery and the specimens were processed in laboratory. The histological sections were stained with hematoxylin-eosin and analyzed by light microscopy. Scores were assigned to the inflammatory process and statistically compared by the Tukey test (P < 0.05). Alendronate paste promoted severe inflammation process at 7 days, with statistically significant difference compared to the control (P < 0.05%). However, at 15 days, there was a regression of inflammation and the presence of connective tissue with collagen fibers, fibroblasts and blood vessels was observed. After 45 days, it was observed the presence of well-organized connective tissue, with collagen fibers and fibroblasts, and few inflammatory cells. No statistical difference was observed between the control and experimental paste at 15 and 45 days. The experimental alendronate paste was considered biocompatible with subcutaneous tissue of rat.

  2. Use of alendronate in peri-implant defect regeneration.

    PubMed

    Meraw, S J; Reeve, C M; Wollan, P C

    1999-02-01

    Previous studies have demonstrated an increase in bone mass and density with use of systemic alendronate sodium. This agent acts as an inhibitor of osteoclast activity, and is thought to result in more net osteoblastic activity. The objective of this study was to determine the effects of locally applied alendronate sodium on guided bone regeneration around dental implants. Six adult mongrel dogs were divided into 2 groups: one group received alendronate-coated dental implants, and the other group served as control. Two types of dental implants were used in each dog: hydroxyapatite (HA)-coated and titanium machine-polished (TMP), for a total of 4 groups. Dental implants were placed immediately after extraction of the right and left second, third, and fourth mandibular premolars; a resorbable collagen membrane was secured over the implants and defects; and the flaps were closed primarily. Fluorescent labels were administered intravenously on days 0, 6, 12, and 22 to measure bone formation rate. Dogs were sacrificed on day 28. The specimens were sectioned and mounted, and bone formation rate was recorded with a computerized microscopic digitizer. Specimens were stained with Stevenel's blue and van Gieson's picric fuchsin. Bone-to-implant contact was recorded with a computerized microscopic digitizer. The results indicated a significant effect of locally applied alendronate (P < 0.0001) with both types of implants (HA and TMP), as well as the HA coating (P< 0.02) on increased bone formation rate. Additionally, alendronate had a significant effect on bone-to-implant contact, with an increase in the TMP model (P < 0.0001) and a decrease in the HA model (P < 0.0001 ). HA coating also had a significant effect on increasing bone-to-implant contact (P < 0.04). The results indicate that alendronate increases early bone formation rate around dental implants. Additionally, the local application as described resulted in greater bone-to-implant contact with TMP implants.

  3. [Role of bones in the physiopathology of idiopathic hypercalciuria: effect of amino-bisphosphonate alendronate].

    PubMed

    Weisinger, J R; Alonzo, E; Machado, C; Carlini, R; Martinis, R; Paz-Martínez, V; Bellorín-Font, E

    1997-01-01

    Previous studies from our laboratory demonstrated that bone mineral content is affected in patients with idiopathic hypercalciuria and that there is a correlation between bone mineral loss and in-vitro cytokine production. At the same time we found that short term treatment with alendronate decreased urinary calcium in these subjects. In the present study we have examined the long-term effects of alendronate treatment (10 mg/day for one year) on urinary calcium, urinary hydroxyproline and bone mineral content in 18 idiopathic hypercalciuric and 8 normocalciuric stone formers. Clinical characteristics, as well as gender and age distribution were similar in both groups. Urinary calcium and hydroxyproline, were measured monthly. Calcium excretion decreased significantly at the end of the first month, and remained lower thereafter (277 +/- 28, before vs. 202 +/- 26 mg/g creatinine, after 12 months on alendronate, p < 0.01). Urinary hydroxyproline decreased significantly during the study (125.5 +/- 32.1 vs. 39.66 +/- 17.5 mg/g creatinine, p < 0.05). Serum calcium, glomerular filtration rate, and urinary sodium, did not change during the study. Lumbar spine bone density (trabecular bone) obtained with X ray absorptiometry revealed a significant increase from 1.162 +/- 0.231 to 1.197 +/- 0.248 g/cm2 (p < 0.01). These changes were associated with a significant decrease in IL-1 alpha mRNA transcription by unstimulated and lipopolysaccharide stimulated blood mononuclear cells, as tested by the reverse transcriptase polymerase chain reaction. No changes were observed in bone cortical sites (femoral neck). Normocalciuric subjects showed no significant changes in urinary calcium. In summary, the changes observed in urinary calcium excretion and different bone metabolic parameters, suggest a role of bone in the pathophysiology of idiopathic hypercalciuria.

  4. Congenital adrenal hyperplasia: Treatment and outcomes.

    PubMed

    Kamoun, Mahdi; Feki, Mouna Mnif; Sfar, Mohamed Habib; Abid, Mohamed

    2013-10-01

    Congenital adrenal hyperplasia (CAH) describes a group of autosomal recessive disorders where there is impairment of cortisol biosynthesis. CAH due to 21-hydroxylase deficiency accounts for 95% of cases and shows a wide range of clinical severity. Glucocorticoid and mineralocorticoid replacement therapies are the mainstays of treatment of CAH. The optimal treatment for adults with CAH continues to be a challenge. Important long-term health issues for adults with CAH affect both men and women. These issues may either be due to the disease or to steroid treatment and may affect final height, fertility, cardiometabolic risk, bone metabolism, neuro-cognitive development and the quality-of-life. Patients with CAH should be regularly followed-up from childhood to adulthood by multidisciplinary teams who have knowledge of CAH. Optimal replacement therapy, close clinical and laboratory monitoring, early life-style interventions, early and regular fertility assessment and continuous psychological management are needed to improve outcome.

  5. Treatment outcome for flexible dosing buprenorphine maintenance treatment.

    PubMed

    Fareed, Ayman; Vayalapalli, Sreedevi; Casarella, Jennifer; Drexler, Karen

    2012-03-01

    Achieving the best treatment outcome with the least cost should be the goal for buprenorphine office-based treatment. We conducted an observational retrospective chart review to compare the treatment outcome for patients (n = 56) receiving high dose of buprenorphine (above 16 mg daily) and patients (n = 21) receiving moderate doses (8-16 mg daily). The percentages of the first four urine drug screens (UDS) positive for opiates were significantly higher for the high-dose group than for the moderate-dose group (F = 7.93, df = 7, p < .0001). However, the percentages of the most recent four UDS positive for opiates were not statistically significant (F = .62, df = 7, p = .74). The difference in the percentages of the first and last UDS for the high-dose group showed significant reduction from admission to most recently but there was no significant difference for the moderate-dose group (t = 3.1, df = 105, p = .002 for the high-dose group and t = 1.1, df = 40, p = .27 for the moderate-dose group). Using flexible buprenorphine dosing schedule with the option of titrating the dose up to 32 mg daily may offer better treatment outcome for patients who would not respond to the lower dose range.

  6. Motivational tools to improve probationer treatment outcomes

    PubMed Central

    Taxman, Faye S.; Walters, Scott T.; Sloas, Lincoln B.; Lerch, Jennifer; Rodriguez, Mayra

    2015-01-01

    Background Motivational interviewing (MI) is a promising practice to increase motivation, treatment retention, and reducing recidivism among offender populations. Computer-delivered interventions have grown in popularity as a way to change behaviors associated with drug and alcohol use. Methods/Design Motivational Assistance Program to Initiate Treatment (MAPIT) is a three arm, multisite, randomized controlled trial, which examines the impact of Motivational Interviewing (MI), a Motivational Computer Program (MC), and Supervision as Usual (SAU) on addiction treatment initiation, engagement, and retention. Secondary outcomes include drug/alcohol use, probation progress, recidivism (i.e., criminal behavior) and HIV/AIDS testing and treatment among probationers. Participant characteristics are measured at baseline, 2, and 6 months after assignment. The entire study will include 600 offenders, with each site recruiting 300 offenders (Baltimore City, Maryland and Dallas, Texas). All participants will go through standard intake procedures for probation and participate in probation requirements as usual. After standard intake, participants will be recruited and screened for eligibility. Discussion The results of this clinical trial will fill a gap in knowledge about ways to motivate probationers to participate in addiction treatment and HIV care. This randomized clinical trial is innovative in the way it examines the use of in-person vs. technological approaches to improve probationer success. Trial Registration NCT01891656 PMID:26009023

  7. Motivational tools to improve probationer treatment outcomes.

    PubMed

    Taxman, Faye S; Walters, Scott T; Sloas, Lincoln B; Lerch, Jennifer; Rodriguez, Mayra

    2015-07-01

    Motivational interviewing (MI) is a promising practice to increase motivation, treatment retention, and reducing recidivism among offender populations. Computer-delivered interventions have grown in popularity as a way to change behaviors associated with drug and alcohol use. Motivational Assistance Program to Initiate Treatment (MAPIT) is a three arm, multisite, randomized controlled trial, which examines the impact of Motivational interviewing (MI), a motivational computer program (MC), and supervision as usual (SAU) on addiction treatment initiation, engagement, and retention. Secondary outcomes include drug/alcohol use, probation progress, recidivism (i.e., criminal behavior) and HIV/AIDS testing and treatment among probationers. Participant characteristics are measured at baseline, 2, and 6 months after assignment. The entire study will include 600 offenders, with each site recruiting 300 offenders (Baltimore City, Maryland and Dallas, Texas). All participants will go through standard intake procedures for probation and participate in probation requirements as usual. After standard intake, participants will be recruited and screened for eligibility. The results of this clinical trial will fill a gap in knowledge about ways to motivate probationers to participate in addiction treatment and HIV care. This randomized clinical trial is innovative in the way it examines the use of in-person vs. technological approaches to improve probationer success. NCT01891656. Copyright © 2015. Published by Elsevier Inc.

  8. Alendronate-associated osteonecrosis of the jaws: a review of the main topics.

    PubMed

    Paiva-Fonseca, F; Santos-Silva, A-R; Della-Coletta, R; Vargas, P-A; Lopes, M-A

    2014-03-01

    Bisphosphonates is a group of inorganic pyrophosphates analogues that suppress bone resorption by inducing osteoclast inactivation, being frequently used for management of diseases affecting bone metabolism, bone metastases and bone tumors. However, since 2003 many cases describing the presence of necrotic bone exposures in the jaws have been described in patients receiving these drugs, what represent a significant complication of bisphosphonates treatment. The overall incidence of bisphosphonate-related osteonecrosis of the jaws is low, ranging from 0.7% to 12%, mainly observed in those patients receiving intravenously treatment. Osteonecrosis of the jaws associated to oral bisphosphonate, particularly alendronate, has also been reported by a number of authors. Considering that alendronate is one of the most used drug worldwide, specially for treatment of osteoporosis, a better understanding of osteonecrosis of the jaws related to its use and how to manage these patients is extremely important. Therefore, in the current manuscript the authors aim to review the most important topics related to this pathological presentation.

  9. Side effects as influencers of treatment outcome.

    PubMed

    Sharif, Zafar

    2008-01-01

    Research relative to the efficacy of a therapeutic agent commands a clinician's greatest interest, but treatment decisions are made based on optimizing efficacy and tolerability/safety considerations. Second-generation atypical antipsychotic drugs are a study in the importance of taking a careful look at the full benefit-risk profile of each drug. The disorders that atypical antipsychotics are approved to treat--schizophrenia, schizoaffective disorder, and bipolar disorder--are associated with an increased rate of certain medical comorbidities compared to the general population. Between-drug differences in efficacy are relatively modest for the atypicals, or between atypicals and conventionals, while differences in safety and tolerability are larger and more clinically relevant. The current article will provide a brief summary of safety-related issues that influence treatment outcome and choice of drug.

  10. Engineered Nanomedicine with Alendronic Acid Corona Improves Targeting to Osteosarcoma

    PubMed Central

    Nguyen, Tuyen Duong Thanh; Pitchaimani, Arunkumar; Aryal, Santosh

    2016-01-01

    We engineered nanomedicine with the stealth corona made up of densely packed bone seeking ligand, alendronic acid. In a typical nanoconstruct, alendronic acid is conjugated with hydrophilic head moiety of phospholipid that has an ability to self-assemble with hydrophobic polymeric core through its hydrophobic long carbon-chain. Proposed nanomedicine has three distinct compartments namely; poly(l-lactic-co-glycolic acid) polymeric core acting as a drug reservoir and skeleton of the nanoconstruct, phospholipid monolayer covers the core acting as a diffusion barrier, and a densely packed alendronic acid corona acting as a stabilizer and targeting moiety. Thus engineered nanomedicine attain spherical entity with ~90 ± 6 nm having negative zeta potential, −37.7 ± 2 mV, and has an ability to load 7 ± 0.3 wt% of doxorubicin. In-vitro bone targeting efficiency of nanomedicine was studied using hydroxyapatite crystals as a bone model, and found significant accumulation of nanoparticle in the crystals. Moreover, cellular internalization studies with mouse osteosarcoma confirm the selectivity of nanomedicine when compared to its internalization in non-targeted mouse melanoma. This nanomedicine shows prolong stability in serum and deliver the drug into the cell exhibiting an IC50 of 3.7 μM. Given the strong interacting property of alendronic acid with bone, the proposed nanomedicine hold promises in delivering drug to bone microenvironment. PMID:27824143

  11. Controlled release of alendronate from nitrogen-doped mesoporous carbon

    DOE PAGES

    Saha, Dipendu; Spurri, Amanda; Chen, Jihua; ...

    2016-04-13

    With this study, we have synthesized a nitrogen doped mesoporous carbon with the BET surface area of 1066 m2/g, total pore volume 0.6 cm3/g and nitrogen content of 0.5%. Total alendronate adsorption in this carbon was ~5%. The release experiments were designed in four different media with sequential pH values of 1.2, 4.5, 6.8 and 7.4 for 3, 1, 3 and 5 h, respectively and at 37 °C to imitate the physiological conditions of stomach, duodenum, small intestine and colon, respectively. Release of the drug demonstrated a controlled fashion; only 20% of the drug was released in the media withmore » pH = 1.2, whereas 64% of the drug was released in pH = 7.4. This is in contrary to pure alendronate that was completely dissolved within 30 min in the first release media (pH = 1.2) only. The relatively larger uptake of alendronate in this carbon and its sustained fashion of release can be attributed to the hydrogen bonding between the drug and the nitrogen functionalities on carbon surface. Based on this result, it can be inferred that this formulation may lower the side effects of oral delivery of alendronate.« less

  12. Controlled release of alendronate from nitrogen-doped mesoporous carbon

    SciTech Connect

    Saha, Dipendu; Spurri, Amanda; Chen, Jihua; Hensley, Dale K.

    2016-04-13

    With this study, we have synthesized a nitrogen doped mesoporous carbon with the BET surface area of 1066 m2/g, total pore volume 0.6 cm3/g and nitrogen content of 0.5%. Total alendronate adsorption in this carbon was ~5%. The release experiments were designed in four different media with sequential pH values of 1.2, 4.5, 6.8 and 7.4 for 3, 1, 3 and 5 h, respectively and at 37 °C to imitate the physiological conditions of stomach, duodenum, small intestine and colon, respectively. Release of the drug demonstrated a controlled fashion; only 20% of the drug was released in the media with pH = 1.2, whereas 64% of the drug was released in pH = 7.4. This is in contrary to pure alendronate that was completely dissolved within 30 min in the first release media (pH = 1.2) only. The relatively larger uptake of alendronate in this carbon and its sustained fashion of release can be attributed to the hydrogen bonding between the drug and the nitrogen functionalities on carbon surface. Based on this result, it can be inferred that this formulation may lower the side effects of oral delivery of alendronate.

  13. The Therapeutic Effects of Combination Therapy with Curcumin and Alendronate on Spine Fusion Surgery in the Ovariectomized Rats.

    PubMed

    Cho, Dae-Chul; Ryu, Kyoungsu; Kim, Kyoung-Tae; Sung, Joo-Kyung

    2017-06-01

    The purpose of this study was to evaluate the therapeutic effects of combination therapy with curcumin and alendronate on spine fusion surgery in ovariectomized rats. Thirty-two female Sprague-Dawley rats (12 weeks old) underwent bilateral ovariectomy (OVX). Eight weeks after surgery, animals underwent intertransverse spine fusion at L4-5. The rats were randomly distributed amongst 4 groups; untreated OVX group, curcumin administered group, alendronate administered group, and the combination therapy group. At 8 weeks after fusion surgery, the animals were sacrificed and the fusion mass was assessed by manual palpation, radiographic scan, and micro-computed tomographic scan. In addition, mechanical strength was determined by a 3-point bending test. Based on the results of manual palpation testing and 3-dimensional micro-computed tomography scanning, solid bone fusion rate was 50% (4 of 8) in the OVX group, 75% (6 of 8) in the alendronate-only and curcumin-only group, and 87.5% (7 of 8) in the combination therapy group, respectively. The combination therapy group had a higher fusion rate compared with the other treatment groups, though not statistically significantly (p>0.05). And the combination therapy group had a significant increase in fusion volume at 8 weeks after spine fusion surgery compared with curcumin-only group (p=0.039). The 3-point bending test showed that combination therapy group had a significantly greater maximal load value compared to that of curcumin-only group (p=0.024). The present study demonstrated that additional treatment of curcumin and alendronate after spine fusion surgery in rat can promote higher fusion volume, and improve bone mechanical strength.

  14. Periodontal treatment outcomes during pregnancy and postpartum.

    PubMed

    Moreira, Carlos Heitor Cunha; Weidlich, Patrícia; Fiorini, Tiago; da Rocha, José Mariano; Musskopf, Marta Liliana; Susin, Cristiano; Oppermann, Rui Vicente; Rösing, Cassiano Kuchenbecker

    2015-09-01

    This study was conducted to compare periodontal therapy outcomes during pregnancy and after delivery. One hundred nine pregnant women up to the 20th gestational week (GW) were randomized into two groups: the test group (comprehensive periodontal therapy during pregnancy) and the control group (comprehensive periodontal therapy after delivery). Periodontal examinations comprised plaque index (PI), gingival index (GI), periodontal probing depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP), and gingival crevicular fluid (GCF) volume. After baseline examination, women in the test group received periodontal treatment up to the 24th GW. The final examination was performed at the 26th to the 28th GW. Women in the control group were treated 30 days after delivery and reexamined 30 days after treatment. Periodontal therapy significantly reduced periodontal inflammation in both groups. The mean percentage of sites with BOP was reduced from 49.14 % (±22.49) to 11.10 % (±7.84) and from 45.71 % (±17.86) to 8.07 % (±5.21) in the test and control groups, respectively (p = 0.95). No statistically significant differences were observed between groups concerning PI, GI, PPD, CAL, and GCF. The reduction in mean percentage of sites with BOP stratified for initial PPD ≥4 mm was higher in the control group (p < 0.01), but no differences were seen regarding GCF in these sites. Hormonal changes during pregnancy do not interfere in treatment outcomes in women with widespread gingival inflammation and limited periodontal destruction. The role of these hormonal changes in pregnant women with different disease patterns remains uncertain. Periodontal health can be reestablished irrespective of the hormonal challenge that takes place during pregnancy.

  15. A comparative study of the effects of daily minodronate and weekly alendronate on upper gastrointestinal symptoms, bone resorption, and back pain in postmenopausal osteoporosis patients.

    PubMed

    Yoshioka, Toru; Okimoto, Nobukazu; Okamoto, Ken; Sakai, Akinori

    2013-03-01

    The purpose of the present study was to precisely compare both the efficacy and abdominal symptom-related quality of life after treatment with daily minodronate and weekly alendronate in patients with primary postmenopausal osteoporosis. The efficacy of the two drugs was assessed based on improvements in a bone turnover marker, back pain, and gastrointestinal symptoms that impair quality of life, which was assessed using the Izumo scale questionnaire. In the minodronate group, there were no significant changes during the treatment period in the specific scores for heartburn, epigastralgia and epigastric fullness, whereas all of the scores were significantly elevated at some time point after drug administration in the alendronate group. Urinary N-telopeptide of type I collagen (uNTX), a bone resorption marker, and bone-specific alkaline phosphatase, a bone formation marker, significantly decreased in both groups, but decreases in uNTX in the minodronate group was observed significantly earlier compared with those in the alendronate group. The back pain scores, which were obtained using a visual analog scale, were significantly reduced in both groups. However, analgesic effects were detected earlier in the minodronate group. In conclusion, compared with weekly alendronate, daily minodronate improved bone turnover and back pain more promptly without causing upper gastrointestinal symptoms.

  16. Clinical and radiological improvement of periodontal disease in patients with type 2 diabetes mellitus treated with alendronate: a randomized, placebo-controlled trial.

    PubMed

    Rocha, M; Nava, L E; Vázquez de la Torre, C; Sánchez-Márin, F; Garay-Sevilla, M E; Malacara, J M

    2001-02-01

    Alendronate (ALN) is an aminobisphosphonate commonly used for osteoporosis in postmenopausal women. We studied the effect of ALN on bone loss prevention in type 2 diabetes mellitus patients with periodontal disease. In a controlled double-blind, randomized study we evaluated prospectively diabetic patients paired by gender and years since diagnosis for 6 months. The study included 40 patients (20 men and 20 women), 50 to 60 years old, with more than 5 years since diagnosis of diabetes and established periodontitis. They were randomly allocated to alendronate (10 mg/daily) or placebo treatment for 6 months. The endpoints of treatment were: the distance between the alveolar bone border and the cemento-enamel-junction (CEJ) evaluated by means of digital radiographic imaging, a biochemical marker of bone resorption (urine N-telopeptide) (Ntx), and periodontal parameters. Metabolic control was assessed at baseline and after 6 months. Baseline and 6-month glycated hemoglobin levels were similar in both groups. Alendronate induced a significant decrease in NTx at 6 months (P = 0.006). Periodontal parameters improved in both groups. However, they were significantly better for the ALN treated group. Alveolar bone border-CEJ distance increased in the placebo, but decreased in the ALN group (P = 0.0003). In type-2 diabetic patients, alendronate induced more improvement in alveolar bone crest height than control therapy. No differences in urinary N-telopeptide or glycated hemoglobin were observed in this short-term randomized controlled pilot trial.

  17. Estimating the Time to Benefit for Preventive Drugs with the Statistical Process Control Method: An Example with Alendronate.

    PubMed

    van de Glind, Esther M M; Willems, Hanna C; Eslami, Saeid; Abu-Hanna, Ameen; Lems, Willem F; Hooft, Lotty; de Rooij, Sophia E; Black, Dennis M; van Munster, Barbara C

    2016-05-01

    For physicians dealing with patients with a limited life expectancy, knowing the time to benefit (TTB) of preventive medication is essential to support treatment decisions. The aim of this study was to investigate the usefulness of statistical process control (SPC) for determining the TTB in relation to fracture risk with alendronate versus placebo in postmenopausal women. We performed a post hoc analysis of the Fracture Intervention Trial (FIT), a randomized, controlled trial that investigated the effect of alendronate versus placebo on fracture risk in postmenopausal women. We used SPC, a statistical method used for monitoring processes for quality control, to determine if and when the intervention group benefited significantly more than the control group. SPC discriminated between the normal variations over time in the numbers of fractures in both groups and the variations that were attributable to alendronate. The TTB was defined as the time point from which the cumulative difference in the number of clinical fractures remained greater than the upper control limit on the SPC chart. For the total group, the TTB was defined as 11 months. For patients aged ≥70 years, the TTB was 8 months [absolute risk reduction (ARR) = 1.4%]; for patients aged <70 years, it was 19 months (ARR = 0.7%). SPC is a clear and understandable graphical method to determine the TTB. Its main advantage is that there is no need to define a prespecified time point, as is the case in traditional survival analyses. Prescribing alendronate to patients who are aged ≥70 years is useful because the TTB shows that they will benefit after 8 months. Investigators should report the TTB to simplify clinical decision making.

  18. Understanding pharmacokinetics to improve tuberculosis treatment outcome

    PubMed Central

    Reynolds, Jonathan; Heysell, Scott K

    2014-01-01

    Introduction Tuberculosis (TB) remains the leading cause of death from a curable infectious disease; drug-resistant TB threatens to dismantle all prior gains in global control. Suboptimal circulating anti-TB drug concentrations can lead to lack of cure and acquired drug resistance. Areas covered This review will introduce pharmacokinetic parameters for key anti-TB drugs, as well as the indications and limitations of measuring these parameters in clinical practice. Current and novel methodologies for delivering anti-TB pharmacokinetic-pharmacodynamic data are highlighted and gaps in operational research described. Expert opinion Individual pharmacokinetic variability is commonplace, underappreciated and difficult to predict without therapeutic drug monitoring (TDM). Pharmacokinetic thresholds associated with poor TB treatment outcome in drug-susceptible TB have recently been described and may now guide the application of TDM, but require validation in a variety of settings and comorbidities. Dried blood spots for TDM and prepackaged multidrug plates for minimum inhibitory concentration testing will overcome barriers of accessibility and represent areas for innovation. Operationalizing pharmacokinetics has the potential to improve TB outcomes in the most difficult-to-treat forms of the disease such as multidrug resistance. Clinical studies in these areas are eagerly anticipated and we expect will better define the rational introduction of novel therapeutics. PMID:24597717

  19. Protein isoprenylation regulates osteogenic differentiation of mesenchymal stem cells: effect of alendronate, and farnesyl and geranylgeranyl transferase inhibitors

    PubMed Central

    Duque, G; Vidal, C; Rivas, D

    2011-01-01

    BACKGROUND AND PURPOSE Protein isoprenylation is an important step in the intracellular signalling pathway conducting cell growth and differentiation. In bone, protein isoprenylation is required for osteoclast differentiation and activation. However, its role in osteoblast differentiation and function remains unknown. In this study, we assessed the role of protein isoprenylation in osteoblastogenesis in a model of mesenchymal stem cells (MSC) differentiation. EXPERIMENTAL APPROACH We tested the effect of an inhibitor of farnesylation [farnesyl transferase inhibitor-277 (FTI-277)] and one of geranylgeranylation [geranylgeranyltransferase inhibitor-298 (GGTI-298)] on osteoblast differentiating MSC. In addition, we tested the effect of alendronate on protein isoprenylation in this model either alone or in combination with other inhibitors of isoprenylation. KEY RESULTS Initially, we found that levels of unfarnesylated proteins (prelamin A and HDJ-2) increased after treatment with FTI-277 concomitantly affecting osteoblastogenesis and increasing nuclear morphological changes without affecting cell survival. Furthermore, inhibition of geranylgeranylation by GGTI-298 alone increased osteoblastogenesis. This effect was enhanced by the combination of GGTI-298 and alendronate in the osteogenic media. CONCLUSIONS AND IMPLICATIONS Our data indicate that both farnesylation and geranylgeranylation play a role in osteoblastogenesis. In addition, a new mechanism of action for alendronate on protein isoprenylation in osteogenic differentiating MSC in vitro was found. In conclusion, protein isoprenylation is an important component of the osteoblast differentiation process that could constitute a new therapeutic target for osteoporosis in the future. PMID:21077849

  20. Morphological changes induced by advanced glycation endproducts in osteoblastic cells: effects of co-incubation with alendronate.

    PubMed

    Gangoiti, María Virginia; Anbinder, Pablo Sebastián; Cortizo, Ana María; McCarthy, Antonio Desmond

    2013-09-01

    Advanced glycation endproducts (AGEs) accumulate with age in various tissues, and are further increased in patients with Diabetes mellitus, in which they are believed to contribute to the development and progression of chronic complications that include a decrease in bone quality. Bisphosphonates are anti-osteoporotic drugs that have been used for the treatment of patients with diabetic bone alterations, although with contradictory results. In the present study, we have evaluated the in vitro alterations on osteoblastic morphology by environmental scanning electron microscopy, in actin cytoskeleton and apoptosis induced by AGEs, as well as the modulation of these effects by alendronate (an N-containing bisphosphonate). Our present results provide evidence for disruption induced by AGEs of the osteoblastic actin cytoskeleton (geodesic domes) and significant alterations in cell morphology with a decrease in cell-substratum interactions leading to an increase in apoptosis of osteoblasts and a decrease in osteoblastic proliferation. High concentrations of alendronate (10(-5)M, such as could be expected in an osteoclastic lacuna) further increase osteoblastic morphological and cytoskeletal alterations. However, low doses of alendronate (10(-8)M, compatible with extracellular fluid levels to which an osteoblast could be exposed for most of its life cycle) do not affect cell morphology, and in addition are able to prevent AGEs-induced alterations and consequently apoptosis of osteoblasts. Copyright © 2013 Elsevier GmbH. All rights reserved.

  1. Femur bone repair in ovariectomized rats under the local action of alendronate, hydroxyapatite and the association of alendronate and hydroxyapatite

    PubMed Central

    Canettieri, Antonio Carlos Victor; Colombo, Carlos Eduardo Dias; Chin, Chung Man; Faig-Leite, Horácio

    2009-01-01

    An evaluation was made of the local action of alendronate sodium (A), hydroxyapatite (HA) and the association of both substances (A + HA), in different molar concentrations, on the femur bone repair of ovariectomized rats. Ninety-eight animals were divided into seven groups: control (C), starch (S), alendronate 1 mol (A1), alendronate 2 mols (A2), hydroxyapatite 1 mol (HA1), hydroxyapatite 2 mols (HA2) and the association of alendronate + hydroxyapatite (A + HA). Rats weighing about 250 g were ovariectomized and 2.5-mm diameter bone defects were made on the left femur 30 days later. Each experimental group had defects filled with appropriate material, except for group C (control). The animals were killed 7 and 21 days after surgery. Histological, histomorphometric and statistical analyses of bone neoformation in the bone defect site were performed. From the histological standpoint, the major differences occurred after 21 days. All specimens in groups C, S, HA1 and HA2 presented linear closure of the bone defect, and most animals in groups A1, A2 and A + HA showed no bone neoformation in the central area of the defect. No statistically significant difference was found among the experimental groups after 7 days; after 21 days, group HA2 presented the highest amount of neoformed bone. There was no significant difference among groups A1, A2 and A + HA in the two study periods. It was concluded that alendronate, either isolated or in association with hydroxyapatite, had an adverse effect on bone repair in this experimental model. Moreover, the hydroxyapatite used here proved to be biocompatible and osteoconductive, with group HA2 showing the best results. PMID:19765106

  2. Treatment and Outcomes of Primary Urethra Cancer.

    PubMed

    Eng, Tony Y; Chen, Tiffany W; Patel, Abhilasha J; Vincent, Jill N; Ha, Chul S

    2017-05-23

    Urethral cancer is a rare malignancy, representing <1% of all malignancies. Optimal management, due to its rarity, presents as a treatment dilemma for physicians. There is a lack of consensus regarding treatment as large randomized trials cannot be performed; thus, optimal management decisions rely on study of retrospective cases. This is a review of our institutional experience with urethral cancer treated with various treatment modalities. A retrospective chart review was performed on 31 patients treated for primary cancer of the urethra from 1958 to 2008. The patients were stratified by sex, histologic type, stage, date of diagnosis, type of treatment, and last follow-up. Early stage cases were designated as Tis-T2N0M0 and advanced cases were designated as T3-4, N+ or M+. Analysis was performed based on clinical stage, treatment modalities and outcomes. Fourteen early stage cases and 17 advanced stage cases of urethral cancer were analyzed. The majority of early stage cases occurred in men (M:F=8:6) and the majority of advanced stage cases occurred in women (M:F=5:12). The most common histology was squamous cell carcinoma for both early and advanced stage cases. Surgery was the preferred modality of treatment for early stage cases (surgery used in 13 cases vs. chemo/radiotherapy used in 1 case) while for advanced cases, radiation ±chemotherapy was commonly used. Overall survival for this series was 45% at mean follow-up of 7 years. Eight of the 14 cases of early stage cancer remained disease free at last follow-up. Comparatively, only 5 of 17 with advanced cancers had no apparent disease at last follow-up. All but one of those patients were treated with combined modality therapy. Patients with early stage urethral cancers do well with single modality therapy, whereas patients who present with advanced cancers may benefit from combined modality therapy. More extensive study is required to recommend a particular treatment protocol. However, in this rare

  3. A comparative study of zoledronic acid and once weekly Alendronate in the management of acute Charcot arthropathy of foot in patients with diabetes mellitus

    PubMed Central

    Bharath, R.; Bal, Arun; Sundaram, Shanmuga; Unnikrishnan, A. G.; Praveen, V. P.; Bhavani, Nisha; Nair, Vasantha; Jayakumar, R. V.; Kumar, Harish

    2013-01-01

    Aim: The aim of this study was to assess and compare the response to two forms of treatment-immobilization with zoledronic acid injection and immobilization with oral weekly Alendronate, in patients with diabetes mellitus and acute Charcot arthropathy (CA) of foot in terms of clinical and radiological parameters. Material and Methods: Patients attending the endocrinology and podiatry clinic with history of diabetes mellitus and Acute CA were taken for study. The patients were randomized into two treatment groups. Group Z-zoledronic acid injection along with total contact cast (TCC). Group A-Tab. Alendronate 70 mg. once a week till the complete clinical resolution of acute CA along with TCC. Forty-five patients were randomized and 40 of them completed the study. The primary end point was complete clinical resolution of acute CA-defined as temperature difference between normal and affected foot <1°F. Results: Among the 40 patients, 30 (75%) had complete clinical resolution. The mean number of days taken for complete clinical resolution since the initiation of treatment (either Zoledronic acid or Alendronate) was approximately 122 days. There was no significant difference in a number of days required for complete clinical resolution, between the two forms of therapy. There was more than 50% reduction in the visual score between the baseline and the final scan. The target to non-target ratio in the skeletal phase also showed an average of 40% reduction from the baseline to the final skeletal scintigraphy. Conclusion: Both Intravenous Zoledronic acid and oral alendronate had comparable efficacy with respect to the time taken for attaining complete clinical resolution of acute CA of foot. However, Alendronate therapy was cost effective among the two. 99mTc MDP bone scan can be used as an adjuvant to the clinical parameters in assessing the response to therapy. PMID:23776862

  4. [Use of alendronate in osteoporosis--is it cost-effective?].

    PubMed

    Kristiansen, I S; Falch, J A; Andersen, L; Aursnes, I

    1997-08-10

    The objective of the analysis was to establish the cost-effectiveness of five years intervention with alendronate in women aged 65 years with a bone mineral density (BMD) of the femoral neck 2.5 SD below peak bone mass. A cost-utility analysis based on a simulation model was used. The risk of future fractures was estimated on the basis of clinical and epidemiologic data. The costs of intervention and of fracture treatment were based on market prices (measurement of BMD), the Norwegian DRG price list (in-patient hospital care), the pay scale of the Norwegian Medical Association (out-patient care, doctor's visits, laboratory tests, radiographs), public accounts (nursing home care, rehabilitation) and customary charges (transport, physiotherapy etc.). The discounted cost per Quality Adjusted Life Year (QALY) was NOK 528,000, NOK 291,000 and NOK 147,000 when BMD was respectively 1.5, 2.5 and 3.5 SD below peak bone masa at onset of intervention. Sensitivity analyses indicate that the cost per QALY is relatively sensitive to future risk of fracture, cost of intervention, discount rate, and magnitude and duration of the effects of the intervention. The results indicate that the use of alendronate competes favourably with other commonly used preventive programmes when administered to women with high risk of fragility fractures.

  5. Alveolar bone dynamics in osteoporotic rats treated with raloxifene or alendronate: confocal microscopy analysis

    NASA Astrophysics Data System (ADS)

    Ramalho-Ferreira, Gabriel; Faverani, Leonardo Perez; Grossi-Oliveira, Gustavo Augusto; Okamoto, Tetuo; Okamoto, Roberta

    2015-03-01

    In this study, the characteristics of the alveolar bone of rats with induced osteoporosis were examined. Thirty-two rats were divided into four groups according to the induction of osteoporosis and drugs administered: OG, osteoporotic rats without treatment (negative control); SG, rats which underwent sham surgery ovariectomy (SHAM); alendronate (AG), osteoporotic rats treated with alendronate; and RG, osteoporotic rats treated with raloxifene (RG). On the 8th day after ovariectomy and SHAM surgeries, drug therapy was started with AG or RG. On the 52nd day, 20 mg/kg calcein was administered to all of the rats, and on the 80th day, 20 mg/kg alizarin red was administered. Euthanasia was performed on the 98th day. The bone area marked by fluorochromes was calculated and data were subjected to two-way ANOVA test and Tukey's post-hoc test (p<0.05). The comparison of the induced osteoporosis groups showed no statistically significant differences in bone turnover only between RG and SG (p=0.074) and AG and OG (p=0.138). All other comparisons showed significant differences (p<0.001). The largest bone turnover was observed in RG and SG groups. RG was the medication that improved the dynamics of the alveolar bone of rats with induced osteoporosis, resembling that of healthy rats.

  6. Technetium-99m-alendronate: a new radiopharmaceutical for bone scanning.

    PubMed

    Arteaga de Murphy, C; Meléndez-Alafort, L; Montoya-Molina, C; Sepúlveda-Méndez, J

    1996-01-01

    The purpose of this paper is to report the preparation of a new technetium-99m-radiopharmaceutical for bone scanning. The chelating agent for 99mTc is a new bisphosphonate, alendronate, 4-amino-1-hydroxy-butylidene-1, 1-bisphosphonate (ABP) used as a treatment for osteoporosis. ABP, because of its amino group, seems to be better suited to form a strong and stable complex with technetium-99m and therefore might be better than 99mTc-etidronate (HEDP) or 99mTc-medronate (MDP) for bone scanning. A sterile dry kit containing APB, a reducing agent and a stabilizer was prepared. The parameters studied were molar concentrations, pH, shelf life, labeling efficiency and radiochemical purity. The oven dried sterile kit was formulated with 5 mg ABP, 0.25 mg stannous fluoride and 0.025 mg gentisic acid at pH 2.5-3.5. The labeling efficiency with 20-1500 MBq of pertechnetate (99mTcO4-) was over 95% at room temperature and was stable for 5 h. Technetium-99m-alendronate was tested in two rabbits and it proved to be a promising new radiopharmaceutical for bone scanning. Work is underway to study 99mTc-ABP biodistribution in a statistically significant number of laboratory animals and, later on, to determine radiopharmacokinetic parameters in normal volunteers.

  7. Cognitive behavioral treatment outcomes in adolescent ADHD.

    PubMed

    Antshel, Kevin M; Faraone, Stephen V; Gordon, Michael

    2014-08-01

    To assess the efficacy of cognitive behavioral therapy (CBT) for managing adolescent ADHD. A total of 68 adolescents with ADHD and associated psychiatric comorbidities completed a manualized CBT treatment protocol. The intervention used in the study was a downward extension of the Safren et al. program for adults with ADHD who have symptoms unresolved by medication. Outcome variables consisted of narrow band (ADHD) and broadband (e.g., mood, anxiety, conduct) symptom measures (Behavior Assessment System for Children-2nd edition and ADHD-Rating Scales) as well as functioning measures (parent/teacher ratings and several ecologically real-world measures). Treatment effects emerged on the medication dosage, parent rating of pharmacotherapy adherence, adolescent self-report of personal adjustment (e.g., self-esteem), parent and teacher ratings of inattentive symptoms, school attendance, school tardiness, parent report of peer, family and academic functioning and teacher report of adolescent relationship with teacher, academic progress, and adolescent self-esteem. Adolescents with ADHD with oppositional defiant disorder were rated by parents and teachers as benefiting less from the CBT intervention. Adolescents with ADHD and comorbid anxiety/depression were rated by parents and teachers as benefiting more from the CBT intervention. A downward extension of an empirically validated adult ADHD CBT protocol can benefit some adolescents with ADHD. © 2012 SAGE Publications.

  8. Arthroscopic treatment of femoroacetabular impingement: early outcomes.

    PubMed

    Polat, Gökhan; Dikmen, Göksel; Erdil, Mehmet; Aşık, Mehmet

    2013-01-01

    The aim of the study was to assess the early outcomes of the arthroscopic treatment of femoroacetabular impingement. Forty-two femoroacetabular impingement (FAI) patients (mean age: 35.1 years, range: 16 to 52 years) treated arthroscopically between 2006 and 2011 in our clinic were retrospectively analyzed. Twenty-five patients had Cam, 6 Pincer and 11 combined femoroacetabular impingement. Mean follow-up time was 28.2 (range: 10 to 72) months. Patients were assessed clinically and functionally using the Non-Arthritic Hip Score (NAHS), modified Harris Hip Score (mHHS), Oxford Hip Score, WOMAC score, and Visual Analogue Scale (VAS) pain scores preoperatively and at the final follow-up. In clinical and functional assessments, there were increases of 24.8 points in mean NAHS, 23.3 in mHHS, 20.6 in WOMAC score and 9.6 in Oxford Hip Score. VAS pain score decreased by 4.9 points in comparison to the preoperative scores. There were no major complications. However, transient pudendal nerve neuropraxia was present in two patients, transient lateral femoral cutaneous nerve neuropraxia in one and asymptomatic heterotopic ossification in one patient. Short-term clinical results of the arthroscopic treatment of the FAI appear to be satisfactory.

  9. Negative Treatment Outcomes of Behavioral Parent Training Programs.

    ERIC Educational Resources Information Center

    Assemany, Amy E.; McIntosh, David E.

    2002-01-01

    The purposes of this review were to: outline literature on negative treatment outcomes of behavioral parent training programs; detail variables found to be predictive of negative treatment outcomes; and suggest future directions of study. It is suggested that despite studies documenting positive outcomes of behavioral parent training programs,…

  10. The effects of systemic alendronate with or without intraalveolar collagen sponges on postextractive bone resorption: a single masked randomized clinical trial.

    PubMed

    Graziani, Filippo; Rosini, Stefano; Cei, Silvia; La Ferla, Fabio; Gabriele, Mario

    2008-07-01

    Alendronate is a bisphosphonate frequently used to reduce bone resorption. It has been used for osteoporosis, Paget's disease, and also as adjunctive therapy for periodontal disease. The aim of this study was to evaluate the effect of systemic alendronate with or without endoalveolar collagen sponge on vertical bone resorption after lower wisdom tooth extraction. Forty patients referred for wisdom tooth impaction were selected. Before surgery, patients were randomly assigned to receive one of the following pharmacologic treatments: no medication (group 1), postextractive endoalveolar collagen sponge (group 2), systemic alendronate for 4 months starting the day of surgery (group 3), and group 2 + group 3 (group 4). Standardized orthopantomographic evaluation was obtained during recruitment (T1), immediately after surgery (T2), and 4 months (T3) to evaluate crestal and alveolar socket changes. Results indicate that at T2, crest and socket level did not show significant differences between the four groups. At T3, test sites treated showed less bone resorption compared with controls. In particular, higher vertical bone height levels and a faster intraalveolar healing were achieved in groups 3 and 4. Systemically given alendronate may be used successfully to reduce vertical bone resorption after wisdom tooth extraction.

  11. Alendronate as an Effective Countermeasure to Disuse Induced Bone loss

    NASA Technical Reports Server (NTRS)

    LeBlanc, Adrian D.; Driscol, Theda B.; Shackelford, Linda C.; Evans, Harlan J.; Rianon, Nahid J.; Smith, Scott M.; Lai, Dejian

    2002-01-01

    Microgravity, similar to diuse immobilization on earth, causes rapid bone loss. This loss is believed to be an adaptive response to the reduced musculoskelatal forces in space and occurs gradually enough that changes occurring during short duration space flight are not a concern. Bone loss, however, will be a major impediment for long duration missions if effective countermeasures are not developed and implemented. Bed rest is used to simulate the reduced mechanical forces in humans and was used to test the hypothesis that oral alendronate would reduce the effects of long duration (17 weeks) inactivity on bone. Eight male subjects were given daily oral doses of alendronate during 17 weeks of horizontal bed rest and compared with 13 male control subjects not given the drug. Efficacy was evaluated based on measurements of bone markers, calcium balance and bone density performed before, during and after the bed rest. The results show that oral alendronate attenuates most of the characteristic changes associated with long duration bed rest and presumably space flight.

  12. Experimental osteonecrosis: development of a model in rodents administered alendronate.

    PubMed

    Conte, Nicolau; Spolidorio, Luis Carlos; Andrade, Cleverton Roberto de; Esteves, Jônatas Caldeira; Marcantonio, Elcio

    2016-08-22

    The main objective of this study was to cause bisphosphonate-related osteonecrosis of the jaws to develop in a rodent model. Adult male Holtzman rats were assigned to one of two experimental groups to receive alendronate (AL; 1 mg/kg/week; n = 6) or saline solution (CTL; n = 6). After 60 days of drug therapy, all animals were subjected to first lower molar extraction, and 28 days later, animals were euthanized. All rats treated with alendronate developed osteonecrosis, presenting as ulcers and necrotic bone, associated with a significant infection process, especially at the inter-alveolar septum area and crestal regions. The degree of vascularization, the levels of C-telopeptide cross-linked collagen type I and bone-specific alkaline phosphatase, as well as the bone volume were significantly reduced in these animals. Furthermore, on radiographic analysis, animals treated with alendronate presented evident sclerosis of the lamina dura of the lower first molar alveolar socket associated with decreased radiographic density in this area. These findings indicate that the protocol developed in the present study opens new perspectives and could be a good starting model for future property design.

  13. The effect of mandatory generic substitution on the safety of alendronate and patients' adherence.

    PubMed

    Lai, Pauline Siew Mei; Chua, Siew Siang; Chong, Yah Huei; Chan, Siew Pheng

    2012-08-01

    Generic medicines are often used in public hospitals. However, data on the quality of generic alendronate, its efficacy, side-effects and medication adherence in clinical practice is scarce. Therefore, this study aimed to compare the side-effects and medication adherence of generic (apo-alendronate*) and proprietary alendronate (Fosamax†). This prospective study involved two groups of patients: (1) postmenopausal osteoporotic women prescribed once-weekly Fosamax (proprietary group) but were switched to apo-alendronate after 2 years ('switched over' group); and (2) patients initiated with once-weekly apo-alendronate (generic group). Participants were recruited from the Osteoporosis Clinic of a tertiary hospital. Data were collected through interviews. Side-effects and medication adherence. A total of 131 participants were recruited: proprietary group = 64 and generic group = 67. An intergroup and a within-group comparison were made. Side-effects were reported by 6 (9.4%), 30 (44.8%) and 12 (18.8%) participants in the proprietary, generic and 'switched over' groups, respectively. Participants who were on generic alendronate were at a significantly higher risk of experiencing side-effects compared to those who were taking proprietary alendronate [odds ratio (OR):7.84 (95% CI: 2.98-20.65), p < 0.001]. However, no significant statistical difference was found between the 'switched over' and the proprietary group [OR: 2.23 (95% CI: 0.78-6.37), p = 0.127]. Four out of 12 (33.3%) patients who experienced side-effects immediately after switching to generic alendronate discontinued generic alendronate due to intolerable gastrointestinal side-effects. There was no difference in medication adherence to generic or proprietary alendronate. Medication adherence to both generic and proprietary alendronate appeared similar although patients who were taking generic alendronate* were significantly more likely to experience side-effects than those on proprietary

  14. Disease Systems Analysis of Bone Mineral Density and Bone Turnover Markers in Response to Alendronate, Placebo, and Washout in Postmenopausal Women

    PubMed Central

    Stone, JA; Verhamme, KM; Danhof, M; Post, TM

    2016-01-01

    A previously established mechanism‐based disease systems model for osteoporosis that is based on a mathematically reduced version of a model describing the interactions between osteoclast (bone removing) and osteoblast (bone forming) cells in bone remodeling has been applied to clinical data from women (n = 1,379) receiving different doses and treatment regimens of alendronate, placebo, and washout. The changes in the biomarkers, plasma bone‐specific alkaline phosphatase activity (BSAP), urinary N‐telopeptide (NTX), lumbar spine bone mineral density (BMD), and total hip BMD, were linked to the underlying mechanistic core of the model. The final model gave an accurate description of all four biomarkers for the different treatments. Simulations were used to visualize the dynamics of the underlying network and the natural disease progression upon alendronate treatment and discontinuation. These results complement the previous applications of this mechanism‐based disease systems model to data from various treatments for osteoporosis. PMID:27869358

  15. Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial.

    PubMed

    Brown, Jacques P; Prince, Richard L; Deal, Chad; Recker, Robert R; Kiel, Douglas P; de Gregorio, Luiz H; Hadji, Peyman; Hofbauer, Lorenz C; Alvaro-Gracia, Jose M; Wang, Huei; Austin, Matthew; Wagman, Rachel B; Newmark, Richard; Libanati, Cesar; San Martin, Javier; Bone, Henry G

    2009-01-01

    Denosumab is a fully human monoclonal antibody that inhibits bone resorption by neutralizing RANKL, a key mediator of osteoclast formation, function, and survival. This phase 3, multicenter, doubleblind study compared the efficacy and safety of denosumab with alendronate in postmenopausal women with low bone mass. One thousand one hundred eighty-nine postmenopausal women with a T-score alendronate weekly (70 mg) plus subcutaneous placebo injections Q6M (n = 595). Changes in BMD were assessed at the total hip, femoral neck, trochanter, lumbar spine, and one-third radius at 6 and 12 mo and in bone turnover markers at months 1, 3, 6, 9, and 12. Safety was evaluated by monitoring adverse events and laboratory values. At the total hip, denosumab significantly increased BMD compared with alendronate at month 12 (3.5% versus 2.6%; p < 0.0001). Furthermore, significantly greater increases in BMD were observed with denosumab treatment at all measured skeletal sites (12-mo treatment difference: 0.6%, femoral neck; 1.0%, trochanter; 1.1%, lumbar spine; 0.6%, one-third radius; p treatment led to significantly greater reduction of bone turnover markers compared with alendronate therapy. Adverse events and laboratory values were similar for denosumab- and alendronate-treated subjects. Denosumab showed significantly larger gains in BMD and greater reduction in bone turnover markers compared with alendronate. The overall safety profile was similar for both treatments.

  16. Adolescent acromegaly: clinical parameters and treatment outcome.

    PubMed

    Bhansali, A; Upreti, V; Dutta, P; Mukherjee, K K; Nahar, U; Santosh, R; Das, S; Walia, R; Pathak, A

    2010-10-01

    Adolescent acromegaly is a rare disorder and these patients present with tall stature/gigantism, tumor mass effects and menstrual irregularities. 34 consecutive (26 males) patients having onset of disease prior to 21 years of age were included in this retrospective analysis. Their clinical features and treatment outcome were studied. Mean age and lag time at presentation were 21.6 +/- 3.9 years and 5.1 +/- 3.5 years respectively. Common presenting manifestations included acral enlargement, tumor mass effects and menstrual irregularities. Mean height at presentation was 174.6 +/- 13.7 cms (range: 150-210 cm) and one third had gigantism (height > or =97th percentile, WHO growth charts). Hypertension and glucose intolerance were seen in 15% and 23.5% respectively. Mean nadir GH after glucose load was 58.2 +/- 13.7 ng/ml and IGF -1 was 534.8 +/- 132.8 ng/ml. Half of the patients had concomitant hyperprolactinemia. Almost all (97%) had macroadenoma and anterior pituitary hormone deficiencies were frequent (75%). Patients with gigantism were younger (19.6 +/- 4.9 vs. 22.6 +/- 2.9 years; p = 0.001), had higher GH values (66.68 +/- 27.22 vs. 53.98 +/- 15.99 ng/ml; p = 0.04) and hypogonadism was more common (90.9% vs. 56.5%, p = 0.03) than those with normal stature. 32 patients (94.1%) were treated primarily with surgery, 7 (21.9%) received post operative radiotherapy. Mean duration of follow up was 33.1 +/- 10.1 months. Only 30% had nadir GH values of <1 ng/ml. One third of adolescent patients had acrogigantism. These patients were younger, had higher GH levels and concurrent hypogonadism was more common. Cure could be achieved only in about one third of the patients.

  17. Outcome Expectations and Associated Treatment Outcomes in Motivational Enhancement Therapy Delivered in English and Spanish

    PubMed Central

    Serafini, Kelly; Decker, Suzanne; Kiluk, Brian D.; Añez, Luis; Paris, Manuel; Frankforter, Tami; Carroll, Kathleen M.

    2016-01-01

    Background and Objectives The relationship between patients’ baseline expectations regarding treatment outcome and actual outcomes has not been widely studied within the field of substance use disorders. We hypothesized that outcome expectations would be unrelated to outcomes in a study investigating Motivational Enhancement Therapy delivered in English (MET-E) consistent with our earlier work, and conducted exploratory analyses in a separate study that investigated the same treatment delivered in Spanish (MET-S). Methods These secondary analyses compared patient outcome expectations and substance use treatment outcomes in two large, multisite randomized controlled clinical trials that evaluated three sessions of MET-E or MET-S. The MET-E sample included 461 participants and the MET-S sample included 405 participants. Outcome expectations were measured by a single item regarding expectations about abstinence prior to initiating treatment. Results Outcome expectations were strongly associated with most substance use outcomes in the MET-S trial (but not in MET-E), even after controlling for severity of substance use at baseline. In MET-S, those who indicated that they were ‘unsure’ that they would achieve abstinence during treatment submitted a greater percentage of drug-positive urine toxicology screens during the treatment period than those who were ‘sure’ they would achieve abstinence (F = 18.83, p <.001). Discussion and Conclusions Patients’ outcome expectations regarding the likelihood of abstinence may be an important predictor of drug use treatment outcomes among Spanish-speakers, but not necessarily for English-speakers. Scientific Significance Individual differences and cultural factors may play a role in the association between outcome expectations and treatment outcomes. PMID:26541501

  18. Effect of alendronate on bone mineral density in adult patients with Laron syndrome (primary growth hormone insensitivity).

    PubMed

    Eshed, Varda; Benbassat, Carlos A; Laron, Zvi

    2006-04-01

    Severe short stature resulting from a deficiency in insulin-like growth factor-I (IGF-I) is a prominent feature of Laron syndrome (LS). Whether patients with LS are osteopenic or not, and whether they need treatment with bisphosphonates, remains uncertain. The aim of this study was to investigate the action of alendronate on the IGF-I-deficient bones of adult patients with LS and osteoporosis, as determined by dual X-ray absorptiometry . Seven patients (5 women and 2 men) of mean age 40.8+/-7.6 years and mean bone mass density (BMD) 0.843+/-0.06 g/cm2 (T score -2.9+/-0.5) at the lumbar spine and 0.734+/-0.11 g/cm2 (T score -2.2+/-0.9) at the femoral neck were treated with alendronate 70 mg once/weekly over a 12-month period. Treatment led to an increase of 5.3% in BMD (p=0.038) at the femoral neck. There was a similar trend at the lumbar spine, but the difference was not statistically significant (2.3%, p=0.34). Mean total alkaline phosphatase decreased by 14% from normal range at baseline (p=0.007). Urinary deoxypyridinoline levels, which were elevated at baseline (10+/-2.3 nM/mMcre), showed a nonsignificant change during treatment. Our study suggests that treatment with alendronate may have positive effects in patients with LS and low BMD on dual X-ray absorptiometry.

  19. Patient Satisfaction and Sustained Outcomes of Drug Abuse Treatment

    PubMed Central

    ZHANG, ZHIWEI; GERSTEIN, DEAN R.; FRIEDMANN, PETER D.

    2009-01-01

    The authors investigated the relationship between patients’ self-rated satisfaction with treatment services during and shortly after treatment with their drug use outcomes at one year follow-up, using a U.S. national panel survey of patients in 62 methadone, outpatient, short-term residential, and long-term residential programs. A favorable evaluation of treatment near the time of discharge had a significant positive relationship with drug use improvement outcomes approximately one year later, independent of the separately measured effects of treatment duration, counseling intensity, patient adherence to treatment protocols, pre-treatment drug use patterns, and other characteristics of patients and treatment programs. PMID:18420772

  20. Psychometric Validation of the Preschool Outcome Questionnaire: A Preschool Treatment Outcome Instrument

    ERIC Educational Resources Information Center

    Barker, David H.; Lloyd, Thad Q.; Stewart, Peter K.; Wells, M. Gawain

    2010-01-01

    Developing normed treatment outcome measures is important to research addressing treatment effectiveness and to improved clinical care. The Preschool Outcome Questionnaire (POQ) is a new measure designed for use with preschool children aged two to six. Designed in collaboration with parents and clinicians, the POQ is brief, easy to administer,…

  1. Prediction of antiepileptic drug treatment outcomes using machine learning

    NASA Astrophysics Data System (ADS)

    Colic, Sinisa; Wither, Robert G.; Lang, Min; Zhang, Liang; Eubanks, James H.; Bardakjian, Berj L.

    2017-02-01

    Objective. Antiepileptic drug (AED) treatments produce inconsistent outcomes, often necessitating patients to go through several drug trials until a successful treatment can be found. This study proposes the use of machine learning techniques to predict epilepsy treatment outcomes of commonly used AEDs. Approach. Machine learning algorithms were trained and evaluated using features obtained from intracranial electroencephalogram (iEEG) recordings of the epileptiform discharges observed in Mecp2-deficient mouse model of the Rett Syndrome. Previous work have linked the presence of cross-frequency coupling (I CFC) of the delta (2-5 Hz) rhythm with the fast ripple (400-600 Hz) rhythm in epileptiform discharges. Using the I CFC to label post-treatment outcomes we compared support vector machines (SVMs) and random forest (RF) machine learning classifiers for providing likelihood scores of successful treatment outcomes. Main results. (a) There was heterogeneity in AED treatment outcomes, (b) machine learning techniques could be used to rank the efficacy of AEDs by estimating likelihood scores for successful treatment outcome, (c) I CFC features yielded the most effective a priori identification of appropriate AED treatment, and (d) both classifiers performed comparably. Significance. Machine learning approaches yielded predictions of successful drug treatment outcomes which in turn could reduce the burdens of drug trials and lead to substantial improvements in patient quality of life.

  2. Adverse events, bone mineral density and discontinuation associated with generic alendronate among postmenopausal women previously tolerant of brand alendronate: a retrospective cohort study

    PubMed Central

    2010-01-01

    Background A rise in gastrointestinal (GI) adverse events (AEs) and a decline in bone mineral density (BMD) was observed in patients previously tolerant to brand alendronate shortly after generic versions were introduced in July 2005 to the Canadian market. The objective of our study was to quantify changes in AE rates and BMD scores, as well as associated alendronate discontinuation among patients before and after switch from brand to generic alendronate. Methods A chart review of postmenopausal women 50 years of age and older between 2003 and 2007 was conducted in two specialized tertiary care referral centers. Patients on alendronate both before and after July 2005 were included. The change in the number of AEs, changes in BMD and associated alendronate discontinuation was compared before and after the switch from brand to generic alendronate. Results 301 women with an average age of 67.6 years (standard deviation (SD) = 9.5) had a total of 47 AEs between July 2003 and December 2007 that resulted in discontinuation of the medication. There was a significant increase in the rate of AEs per patient-months-at-risk from 0.0001 before to 0.0044 after October 2005 (p < 0.001). The most common AEs were GI in nature (stomach pain, GI upset, nausea, and reflux). In addition, 23 patients discontinued alendronate due to BMD reduction after January 2006. In these patients, BMD scores were significantly reduced from their prior BMD measures (change of -0.0534, p < 0.001 for spine BMD and change of -0.0338, p = 0.01 for femur BMD). Among patients who discontinued due to BMD reduction, BMD was stable in the period prior to January 2006 (change of -0.0066, p = 0.5 for spine BMD and change of 0.0011, p = 0.9 for femur BMD); however, testing for reduction after January 2006 in BMD measures (one-sided T-test) revealed there was a significant reduction in BMD scores for both anatomic sites (change of -0.0321, p = .005 for spine, change of -0.0205, p = 0.05 for femur). Conclusions

  3. Adverse events, bone mineral density and discontinuation associated with generic alendronate among postmenopausal women previously tolerant of brand alendronate: a retrospective cohort study.

    PubMed

    Grima, Daniel T; Papaioannou, Alexandra; Airia, Parisa; Ioannidis, George; Adachi, Jonathan D

    2010-04-14

    A rise in gastrointestinal (GI) adverse events (AEs) and a decline in bone mineral density (BMD) was observed in patients previously tolerant to brand alendronate shortly after generic versions were introduced in July 2005 to the Canadian market. The objective of our study was to quantify changes in AE rates and BMD scores, as well as associated alendronate discontinuation among patients before and after switch from brand to generic alendronate. A chart review of postmenopausal women 50 years of age and older between 2003 and 2007 was conducted in two specialized tertiary care referral centers. Patients on alendronate both before and after July 2005 were included. The change in the number of AEs, changes in BMD and associated alendronate discontinuation was compared before and after the switch from brand to generic alendronate. 301 women with an average age of 67.6 years (standard deviation (SD) = 9.5) had a total of 47 AEs between July 2003 and December 2007 that resulted in discontinuation of the medication. There was a significant increase in the rate of AEs per patient-months-at-risk from 0.0001 before to 0.0044 after October 2005 (p < 0.001). The most common AEs were GI in nature (stomach pain, GI upset, nausea, and reflux). In addition, 23 patients discontinued alendronate due to BMD reduction after January 2006. In these patients, BMD scores were significantly reduced from their prior BMD measures (change of -0.0534, p < 0.001 for spine BMD and change of -0.0338, p = 0.01 for femur BMD). Among patients who discontinued due to BMD reduction, BMD was stable in the period prior to January 2006 (change of -0.0066, p = 0.5 for spine BMD and change of 0.0011, p = 0.9 for femur BMD); however, testing for reduction after January 2006 in BMD measures (one-sided T-test) revealed there was a significant reduction in BMD scores for both anatomic sites (change of -0.0321, p = .005 for spine, change of -0.0205, p = 0.05 for femur). Patients who were previously stable on

  4. Histological comparison of alendronate, calcium hydroxide and formocresol in amputated rat molar.

    PubMed

    Cengiz, S Burcak; Batirbaygil, Yildiz; Onur, Mehmet Ali; Atilla, Pergin; Asan, Esin; Altay, Nil; Cehreli, Zafer C

    2005-10-01

    The purpose of this study was to evaluate the potential of alendronate sodium (ALN), a biphosohonate to stimulate hard tissue formation in pulpotomized (amputated) rat molars. Two commonly used pulpotomy materials, calcium hydroxide (CH) and formocresol (FC) were utilized for comparisons. Histological evaluations were performed by observers blinded to treatment allocation on days 7, 15, 30 and 60, followed by statistical analysis of selected histological criteria. In all evaluation periods, hard tissue deposition was evident along the radicular dentin in ALN and CH groups. In days 30 and 60, the latter two groups showed no differences in inflammatory cell response and hard tissue deposition scores (P > 0.05). ALN appears to be capable of maintaining pulpal vitality, while promoting hard tissue formation, similar to CH.

  5. Tuberculosis treatment outcomes in Europe: a systematic review.

    PubMed

    Faustini, A; Hall, A J; Perucci, C A

    2005-09-01

    In order to facilitate the control of tuberculosis (TB), the World Health Organization (WHO) has defined a standardised short-course chemotherapy and a strategy, directly observed therapy. In 2000, WHO surveillance of TB treatments in Europe recorded a successful outcome rate of 77%. The aim of this report is to estimate treatment outcomes in European countries based on published studies and to identify their determinants. A systematic review was conducted of published reports of TB treatment outcomes in Europe. Meta-analysis, meta-regression and subgrouping were used to pool treatment outcomes and analyse associations with mean age, sex, immigration status and multidrug resistance. Of the 197 articles identified in the search, 26 were eligible for the review; 74.4% of outcomes were successful, 12.3% were unsuccessful and 6.8% of patients died. Heterogeneity was high for all outcomes. National estimates were possible for six countries. Multidrug resistance was inversely associated with successful outcome, which were fewer in populations with >9% multidrug-resistant TB, and in patients aged <44 yrs. Successful tuberculosis treatment outcomes were below the 85% threshold suggested by the World Health Organization. There was an inverse association with levels of multidrug-resistant tuberculosis. The unexplained heterogeneity between the studies for unsuccessful outcomes seems to be due to differing interpretations given to World Health Organization definitions.

  6. Is volume important in aneurysm treatment outcome?

    PubMed

    Katsargyris, Athanasios; Klonaris, Chris; Verhoeven, Eric L

    2017-04-01

    Several studies have suggested that surgical procedures performed at high-volume centers may result in superior outcome. Technically more demanding procedures such as aortic aneurysm repair appear to demonstrate a stronger relationship with volume. The present chapter reviewed the literature using the MEDLINE database to identify studies investigating the effect of volume in aortic aneurysm repair outcomes. The great majority of studies identified shows an advantage for high-volume hospitals with regard to perioperative mortality of abdominal (AAA), thoracic (TAA) and thoracoabdominal (TAAA) aortic aneurysm repair. A similar advantage is shown for high-volume surgeons. The volume advantage appears to be less evident for simple endovascular procedures (EVAR & TEVAR), compared to more complex endovascular (F/BEVAR) and open surgical procedures. Superior outcomes observed in high-volume hospitals are not only explained by increased surgeons' experience, but importantly also by a more effective management of intra- and postoperative complications. Confounding factors to be taken into account are the timing of the studies in relation to positive evolution of outcomes in several high-risk procedures, and patient cohorts selected in regions with very low- and very high-volume hospitals only.

  7. Pilot-testing a statewide outcome monitoring system: overview of the California Treatment Outcome Project (CALTOP).

    PubMed

    Evans, Elizabeth; Hser, Yih-Ing

    2004-05-01

    Timely information provided by an effective outcome monitoring system (OMS) is key to making improvements in treatment program effectiveness, service provision, and client outcomes. The California Treatment Outcome Project (CalTOP) developed and pilot-tested an automated outcome monitoring system for California's alcohol and other drug (AOD) system of care. CalTOP was designed to track client movement through treatment programs, measure standardized assessment of client service needs, record service utilization, assess treatment outcomes and client satisfaction, and determine the extent to which treatment produces cost-offsets in other health and social service systems. Information collected by CalTOP revealed that client problem severity at admission was high, services needed were diverse, and treatment services were generally not well matched to the level of problem severity or needs of clients. Also, client retention and length of stay in treatment were generally insufficient to maximize the potential benefits associated with treatment. This article presents the type of information on client demographics and treatment retention that was provided by CalTOP and outlines recommendations for implementing an AOD outcome monitoring system statewide.

  8. Choice of primary outcomes evaluating treatment for heavy menstrual bleeding.

    PubMed

    Herman, M C; Penninx, Jpm; Geomini, P M; Mol, B W; Bongers, M Y

    2016-09-01

    Heavy menstrual bleeding (HMB) is a common problem with a variety of treatment options and many studies have been performed evaluating treatment effects. Consistency in the choice and definition of primary and secondary outcomes is important for the interpretation of data and for the synthesis of data in systematic reviews or individual patient data meta-analysis (IPDMA). To give insight into the primary endpoints and outcome measures chosen in randomised controlled trials (RCTs) and systematic reviews regarding the treatment of HMB. Published systematic reviews and RCTs. Full reports of RCTs or systematic reviews. For RCTs, we used the primary outcomes, as they were used for the sample size calculation. For systematic reviews, all outcomes listed as primary were included. Four authors selected the studies. Twelve different primary outcomes were reported by 66 RCTs, most blood loss- related (44/66 studies). Amenorrhoea was the most common blood loss primary outcome (16/44 studies) and the Pictorial Blood Loss Assessment Chart (PBAC) was the most used measurement tool (27/44 studies). Satisfaction was the second most prevalent primary outcome measure (13/66 studies). In all, 14/26 (54%) systematic reviews prespecified a single primary outcome, whereas all other reviews used composite primary outcomes. Blood loss was the most studied outcome (12/26 reviews). The most used primary outcomes in HMB studies relate to blood loss but there is no consistency regarding the endpoints chosen or measurement tools used to describe blood loss. Standardising outcomes will aid valid comparison and interpretation of data pertaining to the treatment of HMB. A standardised collection of outcomes in heavy menstrual bleeding research is urgently needed. © 2016 Royal College of Obstetricians and Gynaecologists.

  9. Intensity of language treatment: contribution to children's language outcomes.

    PubMed

    Schmitt, Mary Beth; Justice, Laura M; Logan, Jessica A R

    2017-03-01

    Treatment intensity is an important factor in designing and delivering treatments to children with language impairment (LI). However, to date very little is understood about cumulative intervention intensity for children with LI in the US public school system. To examine treatment intensity (dose: time spent on language; frequency: number of sessions; duration: one academic year) as delivered to children with LI within US public schools and to explore its relation to children's language outcomes. A total of 233 children with LI on the caseloads of 73 speech-language pathologists (SLPs) participated. Direct child measures, weekly treatment logs and videotapes were collected to characterize children's language outcomes and treatment experiences. Children on average received 36 min of treatment during 1.3 treatment sessions per week. Children's language severity did not predict children's treatment intensity. Structural equation modelling indicated a significant interaction between frequency and dose of treatment: children receiving high frequency and low dose, or low frequency and high dose treatment had better outcomes than children receiving high frequency, high dose or low frequency, low dose treatment. Findings suggest that more intensive language treatment, measured as time, is not necessarily associated with better treatment outcomes. © 2016 Royal College of Speech and Language Therapists.

  10. Medial Patellar Instability: Treatment and Outcomes

    PubMed Central

    Moatshe, Gilbert; Cram, Tyler R.; Chahla, Jorge; Cinque, Mark E.; Godin, Jonathan A.; LaPrade, Robert F.

    2017-01-01

    Background: Historically, a lateral retinacular release was one of the primary surgical interventions used to treat lateral patellar instability. However, disruption of the lateral structures during this procedure has been associated with medial instability of the patella. Hypothesis: We hypothesize that good to excellent outcomes can be achieved at midterm follow-up after lateral patellotibial ligament reconstruction. Study Design: Case series; Level of evidence, 4. Methods: Thirteen patients were treated for medial patellar instability with a lateral patellotibial ligament reconstruction between May 2011 and December 2013 by a single surgeon. All patients had previously undergone a lateral release procedure and had symptomatic medial patellar instability. Patients were evaluated using patient-reported outcome scores at a minimum of 2 years postsurgery. Results: The mean Lysholm score improved from 45.6 (range, 11-76) to 71.9 (range, 30-91). The median preoperative Tegner activity scale score was 3 (range, 1-7), while the median postoperative score was 4 (range, 1-9). The median Western Ontario and McMaster Universities Arthritis Index (WOMAC) total score improved from 38 (range, 1-57) preoperatively to 6 postoperatively (range, 0-52). The mean patient satisfaction postoperatively was 8.2 (range, 5-10). Conclusion: Significantly improved outcomes can be achieved at midterm follow-up with a low rate of complications when reconstructing the lateral patellotibial ligament in the setting of iatrogenic medial patellar instability. PMID:28451613

  11. Esthesioneuroblastoma With Poor Outcome Despite Extensive Treatment.

    PubMed

    Niyaz, Leyla; Gunduz, Kaan; Meco, Cem; Kankaya, Duygu

    2015-10-01

    Esthesioneuroblastoma is a rare malignant tumor of neuroectodermal origin. It usually presents with nonspecific symptoms, such as nasal obstruction, epistaxis, and pain, but has an aggressive course if the treatment is delayed. The authors report a case of esthesioneuroblastoma in a 47-year-old woman, treated with extensive surgical resection, radiotherapy, and chemotherapy. Despite intensive treatment, the patient developed a local recurrence with systemic metastasis and succumbed 4 months later.

  12. Visceral leishmaniasis treatment outcome and its determinants in northwest Ethiopia

    PubMed Central

    Welay, Getachew Mebrahtu; Alene, Kefyalew Addis

    2017-01-01

    OBJECTIVES Poor treatment outcomes of visceral leishmaniasis (VL) are responsible for the high mortality rate of this condition in resource-limited settings such as Ethiopia. This study aimed to identify the proportion of poor VL treatment outcomes in northwest Ethiopia and to evaluate the determinants associated with poor outcomes. METHODS A hospital-based retrospective study was conducted among 595 VL patients who were admitted to Kahsay Abera Hospital in northwest Ethiopia from October 2010 to April 2013. Data were entered into Epi Info version 7.0 and exported to SPSS version 20 for analysis. Bivariate and multivariate logistic regression models were fitted to identify the determinants of VL treatment outcomes. Adjusted odds ratio (aORs) with 95% confidence intervals (CIs) were used, and p-values <0.05 were considered to indicate statistical significance. RESULTS The proportion of poor treatment outcomes was 23.7%. Late diagnosis (≥29 days) (aOR, 4.34; 95% CI, 2.22 to 8.46), severe illness at admission (inability to walk) (aOR, 1.63; 95% CI, 1.06 to 2.40) and coinfection with VL and human immunodeficiency virus (HIV) (aOR, 2.72; 95% CI, 1.40 to 5.20) were found to be determinants of poor VL treatment outcomes. CONCLUSIONS Poor treatment outcomes, such as death, treatment failure, and non-adherence, were found to be common. Special attention must be paid to severely ill and VL/HIV-coinfected patients. To improve VL treatment outcomes, the early diagnosis and treatment of VL patients is recommended. PMID:28092934

  13. The role of counselling and other factors in compliance of postmenopausal osteoporotic patients to alendronate 70 therapy

    PubMed Central

    Horst-Sikorska, Hanna; Stępień-Kłos, Wioletta; Antkowiak, Agnieszka; Janik, Małgorzata; Cieślak, Karol; Marcinkowska, Michalina; Cegłowska, Agnieszka; Stuss, Michał

    2013-01-01

    Introduction The aim of the study was to assess the role of patient counselling, nurse assistance and effects of biochemical examinations in adherence of women with postmenopausal osteoporosis to alendronate 70 administration over 12 months of therapy. Material and methods Compliance and persistence to alendronate 70 therapy were assessed in a prospective study of 123 postmenopausal women, followed up for one year. The patients were divided into 4 groups (controls, counselled group, biochemical group and nurse assisted group) with monitoring every 6 months; in the nurse assisted group, additional phone contacts were made after 3 and 9 months of treatment. After 12 months, compliance and persistence were analysed. The medication possession ratio (MPR) was regarded as optimal when its value exceeded 80%. Results The compliance to alendronate 70 therapy was 54.03% in the control group and the mean persistence with medication was 197 days. The MPR above 80% was observed in 37.5%, and, after 1 year, 43.75% of patients were found persistent with the therapy. In the remaining groups, both compliance and persistence were higher but not statistically significantly, compared to the control group. Neither patient's age, education, diet, nor physical activity influenced the compliance with prescribed therapy. The most common reason to discontinue therapy was either its side effects or smoking. Conclusions The obtained results suggest that better adherence with medical recommendations is observed in patients who receive additional attention, e.g. counselling, biochemical tests or nursing care. The critical elements for therapy discontinuation were side effects and smoking. PMID:23671440

  14. Effectiveness of local delivery of alendronate in reducing alveolar bone loss following periodontal surgery in rats.

    PubMed

    Binderman, I; Adut, M; Yaffe, A

    2000-08-01

    Mucoperiosteal flaps are used to access bone and root surfaces for debridement, pocket elimination, management of periodontal defects, and in regenerative procedures, as well as in implant surgery. Many reports show that periodontal surgery stimulates osteoclast activity with varying amounts of alveolar bone loss. Alendronate given intravenously significantly reduced alveolar bone loss in mucoperiosteal flap procedures. In the present study, we explored the effectiveness of different concentrations of alendronate, delivered at the surgical site at the time of surgery, in distant delivery in reducing alveolar bone loss. Following elevation of a mucoperiosteal flap next to molars of the rat mandible, a gelatin sponge soaked with different concentrations of alendronate (0, 1, 5, 20, or 40 mg/ml; experiment A) was applied to exposed bone on the experimental side. In the second group (experiment B), alendronate (0, 50, 200, or 400 microg) was topically delivered in the cheek submucosa on the left side (distant to the surgical site) in a small cut into which the gelatin sponge soaked with the drug was placed. Topical application of 200 microg and 400 microg doses of alendronate at the time of surgery was significantly effective (P <0.001) in reducing bone loss. Generally, the percentage of sections with mild bone loss (V1, V2) increased with an increase in the dose of alendronate, while the percentage of sections with severe bone loss (H1, H2) decreased with an increase in alendronate dose. Topical application of 400 microg of alendronate had a systemic effect. This study implies that topical delivery of alendronate at the time of surgery reduces bone loss in periodontal procedures involving mucoperiosteal flap surgery. The most effective dose is 200 microg for topical delivery at the surgical site and 400 microg for distant sites.

  15. Outcome Studies in the Treatment of Panic Disorder: A Review.

    ERIC Educational Resources Information Center

    Beamish, Patricia M.; And Others

    1996-01-01

    Reviews outcome studies in the treatment of panic disorder without agoraphobia for adults. Presents evidence supporting the efficacy of psychopharmacological and cognitive-behavioral interventions. Addresses the need for standards of care in counseling persons with panic disorder. (RB)

  16. Substance abuse treatment for mothers: treatment outcomes and the impact of length of stay.

    PubMed

    Conners, Nicola A; Grant, April; Crone, Cynthia C; Whiteside-Mansell, Leanne

    2006-12-01

    This article examines the treatment outcomes of 305 women enrolled in a comprehensive, residential substance abuse treatment program for pregnant and parenting women and their children. The women were assessed at intake and three times in the year after discharge. Analyses focused on change in client functioning over time, and investigating the impact of length of stay in treatment on client outcomes. Comparisons of clients' functioning before and after treatment suggest significant improvements in a number of domains, including substance use, employment, legal involvement, mental health, parenting attitudes, and risky behaviors. For most outcome domains, results suggest that longer treatment stays are associated with more positive outcomes.

  17. Efficacy and Safety of Weekly Alendronate Plus Vitamin D3 5600 IU versus Weekly Alendronate Alone in Korean Osteoporotic Women: 16-Week Randomized Trial

    PubMed Central

    Kim, Kwang Joon; Min, Yong-Ki; Koh, Jung-Min; Chung, Yoon-Sok; Kim, Kyoung Min; Byun, Dong-Won; Kim, In Joo; Kim, Mikyung; Kim, Sung-Soo; Min, Kyung Wan; Han, Ki Ok; Park, Hyoung Moo; Shin, Chan Soo; Choi, Sung Hee; Park, Jong Suk; Chung, Dong Jin; Mok, Ji Oh; Baek, Hong Sun; Moon, Seong-Hwan; Kim, Yong Soo

    2014-01-01

    Vitamin D (vit-D) is essential for bone health, although many osteoporosis patients have low levels of 25-hydroxy-vit-D [25(OH)D]. This randomized, open-label study compared the effects of once weekly alendronate 70 mg containing 5600 IU vit-D3 (ALN/D5600) to alendronate 70 mg without additional vit-D (ALN) on the percent of patients with vit-D insufficiency [25(OH)D <15 ng/mL, primary endpoint] and serum parathyroid hormone (PTH, secondary endpoint) levels in postmenopausal, osteoporotic Korean women. Neuromuscular function was also measured. A total of 268 subjects were randomized. Overall, 35% of patients had vit-D insufficiency at baseline. After 16-weeks, there were fewer patients with vit-D insufficiency in the ALN/D5600 group (1.47%) than in the ALN group (41.67%) (p<0.001). Patients receiving ALN/D5600 compared with ALN were at a significantly decreased risk of vit-D insufficiency [odds ratio=0.02, 95% confidence interval (CI) 0.00-0.08]. In the ALN/D5600 group, significant increases in serum 25(OH)D were observed at weeks 8 (9.60 ng/mL) and 16 (11.41 ng/mL), where as a significant decrease was recorded in the ALN group at week 16 (-1.61 ng/mL). By multiple regression analysis, major determinants of increases in serum 25(OH)D were ALN/D5600 administration, seasonal variation, and baseline 25(OH)D. The least squares mean percent change from baseline in serum PTH in the ALN/D5600 group (8.17%) was lower than that in the ALN group (29.98%) (p=0.0091). There was no significant difference between treatment groups in neuromuscular function. Overall safety was similar between groups. In conclusion, the administration of 5600 IU vit-D in the ALN/D5600 group improved vit-D status and reduced the magnitude of PTH increase without significant side-effects after 16 weeks in Korean osteoporotic patients. PMID:24719139

  18. Treatment outcome of otomycosis in Ilorin, Nigeria.

    PubMed

    Ologe, F E; Nwabuisi, C

    2002-01-01

    Among 141 patients suspected of having otomycosis, 76 (53.9%) were mycologically confirmed. The fungi isolated were Aspergillus sp (63.4%), Candida (35.5%) and Mucor (1.3%). Ninety-six per cent were symptom free within 2 weeks of topical application of 1% clotrimazole cream, after thorough failures in the cleaning of debri in the ear canal. Treatment failures were minimal, including recurrence (2.6%), acute otitis externa (1.3%), foreign body in the ear (1.3%) and blocking of ear by therapeutic agent (2.6%). This treatment regimen is simple, efficacious, cost effective and safe; hence it is recommended for adoption in the management of otomycosis.

  19. Childhood tuberculosis in Bhutan: profile and treatment outcomes

    PubMed Central

    Dorji, T.; Edgnton, M. E.; Kumar, A. M. V.; Wangchuk, D.; Dophu, U.; Jamtsho, T.; Rinzin, C.

    2013-01-01

    Setting: All hospitals and health centres under the National Tuberculosis Control Programme (NTCP) in Bhutan. Objective: To describe the number and proportion of childhood tuberculosis (TB) cases registered under the NTCP in 2010, their demographic and clinical characteristics and any associations with treatment outcomes. Design: Retrospective cohort study involving a review of TB treatment cards and registers. Results: Of 1332 TB cases registered, 187 (14%) were children aged <15 years, 75 (40%) were aged <5 years, and 180 (96%) were new cases; nearly half were extra-pulmonary TB, with lymphadenitis being the most common form. The overall treatment success rate was 93%, and none of the demographic and clinical characteristics were associated with treatment outcomes. A few recording deficiencies were identified. Conclusion: TB in children is well recognised in Bhutan, and their treatment outcomes were excellent. PMID:26392988

  20. Evaluation of modal damping factor as a diagnostic tool for osteoporosis and its relation with serum osteocalcin and collagen I N-telopeptide for monitoring the efficacy of alendronate in ovariectomized rats.

    PubMed

    Christopoulou, G E; Stavropoulou, A; Anastassopoulos, G; Panteliou, S D; Papadaki, E; Karamanos, N K; Panagiotopoulos, E

    2006-06-07

    Osteoporosis is a metabolic bone disease characterized by reduced bone mass and deterioration of bone microarchitecture. It results from the shift of the osteoblast-osteoclast activity equilibrium in favor of the later. Although, a number of biochemical markers, such as collagen I N-telopeptide (NTx) and osteocalcin (OC), have been used for monitoring bone remodeling, a new, monitoring, non-invasive method, which is based on the measurement of the dynamic characteristic of bone and is known as modal damping factor (MDF), has not been evaluated as a diagnostic tool for osteoporosis. Bisphosphonates, such as alendronate, have an established role in the treatment of osteoporosis. The aim of the present study was, therefore, to evaluate the effects of alendronate on the levels of MDF, serum NTx and OC on osteoporosis induced by ovariectomy in rats. Furthermore, the effects of alendronate on osteoporosis have been histologically evaluated. Fifteen adult female Wistar rats were bilaterally ovariectomized and osteoporosis was histologically confirmed and by the use of peripheral quantitative computerized tomography (pQCT). MDF was applied to assess the bone structural integrity. The serum levels of NTx (37.4+/-0.5 nM bone collagen equivalents, BCE) and OC (111.0+/-8.2 ng/mL) were found to significantly increase following ovariectomy (72.0+/-2.9 nM BCE and 213.5+/-12.1 ng/mL, respectively, p<0.001). As assessed by histology and the levels of NTx and OC in sera, animals treated with alendronate presented a statistically significant deceleration in the progression of the disease in comparison to the no-therapy control group (alendronate group NTx levels: 146.3+/-8.9 nM BCE versus no-therapy control group NTx levels: 265.3+/-14.0 nM BCE, p<0.001, alendronate group OC levels: 205.6+/-18.2 ng/mL versus no-therapy group OC levels: 353.9+/-26.1 ng/mL, p<0.001). Data obtained from the vibration analysis performed illustrated that the change in damping was equal or greater to the

  1. Modeling longitudinal changes in buprenorphine treatment outcome for opioid dependence.

    PubMed

    Saleh, M I

    2014-11-01

    The present analysis describes the longitudinal change in buprenorphine treatment outcome. It also examines several participant characteristics to predict response to buprenorphine. Participants (n=501, age>15 years) received buprenorphine/naloxone treatment for 4 weeks, and then were randomly assigned to undergo dose tapering over either 7 days or 28 days. An empirical model was developed to describe the longitudinal changes in treatment outcome. Several patient characteristics were also examined as possible factors influencing treatment outcome. We have developed a model that captures the general behavior of the longitudinal change in the probability of having an opioid-negative urine sample following buprenorphine treatment. The model captures both the initial increase (i. e., initial response) and the subsequent decrease (i. e., relapse to opioid) in the likelihood of providing an opioid-negative urine sample. Characteristics associated with successful buprenorphine treatment outcome include: having a negative urine test for drugs, having alcohol problems [assessed using alcohol domain of addiction severity index (ASI-alcohol)] at screening, being older, and receiving low cumulative buprenorphine dose. However, ASI-alcohol values were generally low which make the application of the proposed alcohol effect for patients with more severe alcohol problems questionable. A novel approach for analyzing buprenorphine treatment outcome is presented in this manuscript. This approach describes the longitudinal change in the probability of providing an opioid-free urine sample instead of considering opioid use outcome at a single time point. Additionally, this model successfully describes relapse to opioid. Finally, several patient characteristics are identified as predictors of treatment outcome. © Georg Thieme Verlag KG Stuttgart · New York.

  2. Relationship factors and outcome in child anxiety treatment studies.

    PubMed

    Fjermestad, Krister W; Mowatt Haugland, Bente Storm; Heiervang, Einar; Ost, Lars-Göran

    2009-04-01

    This study reviews 19 randomized controlled trials examining the association between three relationship factors - participation, treatment involvement, and therapeutic relationship - and outcome of cognitive-behavioral anxiety treatments for children and adolescents. In 12 studies, parent participation was considered as an independent variable compared to child-only participation. In three studies, parental involvement was measured. Child involvement was measured in one study. The child's perception of the therapeutic relationship was considered in three studies. Six studies found a significant positive effect of parent participation on diagnostic status, symptom level, or global functioning outcome measures. One study found a significant effect of parental involvement on global outcome measures. Another study found a significant positive association between child involvement and symptom measures and global functioning measures. No association was found between the quality of the child's perception of the therapeutic relationship and treatment outcome. Clinical implications are discussed.

  3. Alendronate improves vitamin D-resistant osteopenia triggered by gastrectomy in patients with gastric cancer followed long term.

    PubMed

    Suzuki, Yutaka; Ishibashi, Yoshio; Omura, Nobuo; Kawasaki, Naruo; Kashiwagi, Hideyuki; Yanaga, Katsuhiko; Abo, Masahiro; Urashima, Mitsuyoshi

    2005-01-01

    Gastrectomy/gastric bypass has been used for patients with gastric cancer, and its application is now expanding to treating patients with morbid obesity, the prevalence of which is increasing worldwide. It is well known that gastrectomy leads to osteopenia, but the underlying pathophysiology and optimum treatments for this disorder have not been delineated. We followed 13 patients who showed progressive osteopenia (bone mineral density T-score<-2.4 SD) after gastrectomy/gastric bypass due to gastric cancer and who were resistant to long-term treatment (mean, 6 years) of active vitamin D3 and prospectively studied the effects of alendronate, a bisphosphonate, on osteopenia-related parameters for 2 years. Oral administration of alendronate in addition to vitamin D3 led to remarkable improvement within 2 years, not only in clinical symptoms, such as radial bone fractures and lumbar pain, but also in parameters for osteopenia, including decreased bone mineral density of the lumbar spine (P<0.01), decreased concentrations of calcium (P<0.05), increased urine levels of deoxypyridinoline (P<0.01), increased serum levels of bone-specific alkaline phosphatase (P<0.01), increased serum levels of osteocalcin (P<0.01), and increased serum levels of intact parathyroid hormone (P<0.05), although body weight did not alter. These results suggest that bisphosphonate may improve osteopenia after gastrectomy/gastric bypass.

  4. Willingness for treatment as a predictor of retention and outcomes.

    PubMed

    Erickson, J R; Stevens, S; McKnight, P; Figueredo, A J

    1995-01-01

    Retention in drug treatment is important to successful outcomes. The purpose of this study was to test assumptions made in the development and implementation of the ASSET project. The three assumptions were that living conditions of the homeless adult drug user influence willingness for treatment; willingness relates to treatment tenure; and, conditions, willingness and time in treatment influence treatment outcomes. Data on alcohol use, drug use, employment and housing as well as motivation, readiness and suitability of treatment were collected from 494 homeless adults at baseline and at follow-up. Data were subjected to multivariate causal analysis using factor analytic structural equations modeling. Practical fit indices were acceptable. The measurement model confirmed a higher order construct labelled willingness encompassing motivation, readiness and suitability. The structural model demonstrated that willingness positively related to treatment tenure; willingness positively influenced change in drug use and housing; and, tenure related positively to change in housing.

  5. [Hyponatremia: effective treatment based on calculated outcomes].

    PubMed

    Vervoort, G; Wetzels, J F M

    2006-09-30

    A 78-year-old man was treated for symptomatic hyponatremia. Despite administration of an isotonic NaCl 0.9% solution, plasma sodium remained unchanged due to high concentrations of sodium and potassium in the urine. After infusion of a hypertonic NaCl solution, a satisfactory increase in plasma sodium was reached and symptoms resolved gradually. The hyponatremia was found to be caused by hypothyroidism, which was treated. A 70-year-old female was admitted to the hospital with loss of consciousness and hyponatremia. She was treated initially with a hypertonic NaCl 2.5% solution, which resulted in a steady increase in plasma sodium and a resolution of symptoms. Treatment was changed to an isotonic NaCl 0.9% infusion to attenuate the rise of serum sodium. Nevertheless plasma sodium increased too rapidly due to increased diuresis and reduced urinary sodium and potassium excretion. A slower increase in plasma sodium was achieved by administering a glucose 5% infusion. Hyponatremia is frequently observed in hospitalised patients. It should be treated effectively, and the rate of correction should be adapted to the clinical situation. Effective treatment is determined by calculating changes in effective osmoles and the resulting changes in the distribution of water over extra- and intracellular spaces. Changes in urine production and urinary excretion of sodium and potassium should be taken into account.

  6. Epilepsy in Qatar: Causes, treatment, and outcome.

    PubMed

    Haddad, Naim; Melikyan, Gayane; Al Hail, Hassan; Al Jurdi, Ayman; Aqeel, Faten; Elzafarany, Abdullah; Abuhadra, Nour; Laswi, Mujahed; Alsamman, Yasser; Uthman, Basim; Deleu, Dirk; Mesraoua, Boulenouar; Alarcon, Gonzalo; Azar, Nabil; Streletz, Leopold; Mahfoud, Ziyad

    2016-10-01

    Qatar is a small country on the Eastern coast of the Arabian Peninsula. Its population is a unique mixture of native citizens and immigrants. We aimed to describe the features of epilepsy in Qatar as such information is virtually lacking from the current literature. We summarized information retrospectively collected from 468 patients with epilepsy seen through the national health system adult neurology clinic. Epilepsy was classified as focal in 65.5% of the cases and generalized in 23%. Common causes of epilepsy were as follows: stroke (9%), hippocampal sclerosis (7%), infections (6%), and trauma (6%). Sixty-six percent of patients were receiving a single antiepileptic drug, with levetiracetam being the most frequently prescribed drug (41% of subjects). When the patients were divided by geographical background, remote infections caused the epilepsy in 15% of Asian patients (with neurocysticercosis accounting for 10%) but only in 1% of Qatari and 3% of Middle East/North African subjects (with no reported neurocysticercosis) (p<0.001). Cerebrovascular and neurodegenerative etiologies were the most prominent in Qataris, accounting for 14% (p=0.005) and 4% (p=0.03) of cases, respectively. The choice of antiepileptic drugs varied also according to the regional background, but the seizure freedom rate did not, averaging at 54% on the last clinic visit. To our knowledge, this is the first detailed information about epilepsy in Qatar. The geographical origin of patients adds to the heterogeneity of this disorder. Neurocysticercosis should be in the etiological differential diagnosis of epilepsy in patients coming from Southeast Asian countries, despite the fact that it is not endemic to Qatar. The choice of antiepileptic drugs is influenced by the availability of individual agents in the patients' native countries but had no bearing on the final seizure outcome. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  7. Overview of 5-year followup outcomes in the drug abuse treatment outcome studies (DATOS).

    PubMed

    Hubbard, Robert L; Craddock, S Gail; Anderson, Jill

    2003-10-01

    Followup results from the Drug Abuse Treatment Outcome Studies (DATOS) 1-year and 5-year followups were used to describe the long-term outcomes of drug treatment and to further clarify the relationship between treatment duration and post-treatment outcomes in four treatment modalities: outpatient methadone, long-term residential (LTR), outpatient drug free (ODF), and short-term inpatient. Methods replicating those used in earlier analyses of the DATOS 1-year followup of 2,966 patients admitted to treatment in 1991-1993 and those of the Treatment Outcome Prospective Study patients admitted in 1979-1981 were employed. DATOS is a non-experimental longitudinal study conducted within the natural settings of 96 treatment programs in the U.S.A. The study followed patients during and after treatment at specified periods of time. Prevalence of drug use and behaviors were evaluated for the year prior to treatment; and the post-treatment time frames defined by the 1- and 5-year followups. In addition, the multivariate analytic technique of generalized estimating equations was used to examine the relationship of treatment duration and outcomes across both followups while also controlling for patient characteristics and pretreatment levels of behaviors. The 5-year stratified followup sample included 1,393 of the same individuals in the 1-year followup sample. Analyses were restricted to patients participating in both followups. Reductions in prevalence of cocaine use in the year after treatment (compared to the preadmission year) by patients were associated with longer treatment durations (particularly 6 months or more in LTR and ODF). In addition, reductions in illegal activity and increases in full-time employment were related to treatment stays of 6 months or longer for patients in LTR. The DATOS results from the 1-year and 5-year post-treatment followup combined suggest the stability of outcomes of substance abuse treatment. While results are generally consistent with the

  8. Client Engagement Characteristics Associated with Problem Gambling Treatment Outcomes

    ERIC Educational Resources Information Center

    Dowling, Nicki A.; Cosic, Sanja

    2011-01-01

    Previous research examining the factors associated with problem gambling treatment outcomes has examined client factors and to date, treatment characteristics, therapist factors, and client-therapist interactions have essentially remained unexplored. This study aimed to investigate how client engagement variables (client-rated therapeutic…

  9. Client Engagement Characteristics Associated with Problem Gambling Treatment Outcomes

    ERIC Educational Resources Information Center

    Dowling, Nicki A.; Cosic, Sanja

    2011-01-01

    Previous research examining the factors associated with problem gambling treatment outcomes has examined client factors and to date, treatment characteristics, therapist factors, and client-therapist interactions have essentially remained unexplored. This study aimed to investigate how client engagement variables (client-rated therapeutic…

  10. Posttreatment Factors Influencing Outcome of Adolescent Chemical Dependency Treatment.

    ERIC Educational Resources Information Center

    Shoemaker, Ruth H.; Sherry, Patrick

    1991-01-01

    Adolescents (n=144) in in-patient chemical dependency treatment completed questionnaires designed to determine pre- and posttreatment environmental, psychological, and problem severity influences on outcome of treatment. Results indicated that posttreatment psychosocial environment measures and pretreatment problem severity indicators consistently…

  11. Differences in Outcome Trajectories of Children in Residential Treatment

    ERIC Educational Resources Information Center

    Helgerson, Jena; Martinovich, Zoran; Durkin, Elizabeth; Lyons, John S.

    2005-01-01

    At least three circumstances have converged to focus attention on the outcomes associated with residential treatment. First, the reduction in lengths of stay in the psychiatric hospital has resulted in residential treatment becoming the most expensive service on a per episode basis. Second, the increasing emphasis on the identification and use of…

  12. Exploring the Relationship between Conduct Disorder and Residential Treatment Outcomes

    ERIC Educational Resources Information Center

    Shabat, Julia Cathcart; Lyons, John S.; Martinovich, Zoran

    2008-01-01

    We examined the differential outcomes in residential treatment for youths with conduct disorder (CD)--with special attention paid to interactions with age and gender--in a sample of children and adolescents in 50 residential treatment centers and group homes across Illinois. Multi-disciplinary teams rated youths ages 6-20 (N = 457) on measures of…

  13. Improving Outcome for Mental Disorders by Enhancing Memory for Treatment

    PubMed Central

    Harvey, Allison G.; Lee, Jason; Smith, Rita L.; Gumport, Nicole B.; Hollon, Steven D.; Rabe-Hesketh, Sophia; Hein, Kerrie; Dolsen, Michael R.; Hamen, Kristen; Kanady, Jennifer C.; Thompson, Monique A.; Abrons, Deidre

    2017-01-01

    Summary Patients exhibit poor memory for treatment. A novel Memory Support Intervention, derived from basic science in cognitive psychology and education, is tested with the goal of improving patient memory for treatment and treatment outcome. Adults with major depressive disorder (MDD) were randomized to 14 sessions of cognitive therapy (CT)+Memory Support (n = 25) or CT-as-usual (CTMS; n = 23). Outcomes were assessed at baseline, post-treatment and 6 months later. Memory support was greater in CT+Memory Support compared to the CT-as-usual. Compared to CT-as-usual, small to medium effect sizes were observed for recall of treatment points at post-treatment. There was no difference between the treatment arms on depression severity (primary outcome). However, the odds of meeting criteria for ‘response’ and ‘remission’ were higher in CT+Memory Support compared with CT-as-usual. CT+Memory Support also showed an advantage on functional impairment. While some decline was observed, the advantage of CT+Memory Support was evident through 6-month follow-up. Patients with less than 16 years of education experience greater benefits from memory support than those with 16 or more years of education. Memory support can be manipulated, may improve patient memory for treatment and may be associated with an improved outcome. PMID:27089159

  14. Exploring the Relationship between Conduct Disorder and Residential Treatment Outcomes

    ERIC Educational Resources Information Center

    Shabat, Julia Cathcart; Lyons, John S.; Martinovich, Zoran

    2008-01-01

    We examined the differential outcomes in residential treatment for youths with conduct disorder (CD)--with special attention paid to interactions with age and gender--in a sample of children and adolescents in 50 residential treatment centers and group homes across Illinois. Multi-disciplinary teams rated youths ages 6-20 (N = 457) on measures of…

  15. Does Smoking Intervention Influence Adolescent Substance Use Disorder Treatment Outcomes?

    ERIC Educational Resources Information Center

    Myers, Mark G.; Prochaska, Judith J.

    2008-01-01

    Although tobacco use is reported by the majority of substance use disordered (SUD) youth, little work has examined tobacco focused interventions with this population. The present study is an initial investigation of the effect of a tobacco use intervention on adolescent SUD treatment outcomes. Participants were adolescents in SUD treatment taking…

  16. Does Smoking Intervention Influence Adolescent Substance Use Disorder Treatment Outcomes?

    ERIC Educational Resources Information Center

    Myers, Mark G.; Prochaska, Judith J.

    2008-01-01

    Although tobacco use is reported by the majority of substance use disordered (SUD) youth, little work has examined tobacco focused interventions with this population. The present study is an initial investigation of the effect of a tobacco use intervention on adolescent SUD treatment outcomes. Participants were adolescents in SUD treatment taking…

  17. Outcomes after treatment of acute aortic occlusion.

    PubMed

    de Varona Frolov, Serguei R; Acosta Silva, Marcela P; Volo Pérez, Guido; Fiuza Pérez, Maria D

    2015-11-01

    Acute aortic occlusion (AAO) is a rare disease with high morbidity and mortality. The aim of this study was to describe the results of surgical treatment of acute aortic occlusion and risk factors for mortality. Retrospective review of the clinical history of 29 patients diagnosed and operated on for AAO during 28 years. The following variables were analysed: age, sex, tabaco use, diabetes, chronic renal insufficiency, chronic heart failure, atrial fibrillation, arterial hypertension, symptoms, diagnosis and treatment, 30-day mortality and long-term survival. A univariant analysis was performed of variables related to mortality. Twenty-nine patients were included (18 male) with a mean age of 66,2 years. The aetiology was: embolism (EM) in 11 cases and Thrombosis (TR) in 18 cases. The surgical procedures performed included bilateral transfemoral thrombectomy (14 cases), aorto-bifemoral by-pass (8 cases), axilo uni/bifemoral by-pass (5 cases) and aortoiliac and renal tromboendarterectomy (2 cases). Morbidity included: renal failure (14 cases), mesenteric ischemia (4 cases), cardiac complications (7 cases), respiratory complications (5 cases) and loss of extremity (2 cases). The in-hospital mortality was 21% (EM 0%, TR 21%). The estimated survival at 1.3 and 5 years was 60, 50 and 44% respectively. Age (p=0.032), arterial hypertension (p=0.039) and aetiology of the AAO (p=0.039) were related to mortality. Acute aortic occlusion is a medical emergency with high mortality rates. Acute renal failure is the most common postoperative complication. Copyright © 2012 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  18. Predictors of substance abuse treatment outcomes in Tennessee.

    PubMed

    Kedia, Satish; Williams, Charles

    2003-01-01

    In planning and implementing programs to treat substance abuse, it is important to understand which factors influence post-treatment abstinence. This article identifies and analyzes several variables important in predicting the likelihood of abstinence among substance abuse clients. The data used in this study was collected from 1,350 clients treated for alcohol or drug abuse in residential, halfway house, or outpatient facilities in Tennessee. We analyzed 22 variables as possible treatment outcome predictors by using two statistical procedures: stepwise logistic regression analysis and Quick, Unbiased, Efficient, Statistical Tree (QUEST) analysis, a tree-structured classification algorithm analysis. We found one pretreatment, five in-treatment, and three post-treatment variables to be significant predictors of treatment outcome: previous treatment history, perceived helpfulness of the treatment, simultaneous treatment for mental health, number of days in treatment,completion of treatment, special skills training during treatment, obtaining healthcare services for major physical health problem after treatment, living with someone using alcohol or drugs post treatment, and arrest record since treatment.

  19. Methodological Challenges in Treatment Outcome Research With Ethnic Minorities

    PubMed Central

    Lau, Anna S.; Chang, Doris F.; Okazaki, Sumie

    2015-01-01

    Treatment outcome research focused on ethnic minorities is critically needed to eliminate mental health disparities. Because the conduct of treatment outcome research with ethnic minorities is difficult and complex, we discuss key challenges and present some methodological options suited to provide answers to specific types of questions. We focus first on the randomized clinical trial (RCT) paradigm, reviewing specific challenges facing investigators conducting ethnically inclusive trials. We then highlight the promise of other methods of inquiry to expand the science on mental health treatment with ethnic minorities. PMID:21058823

  20. Universal bone densitometry screening combined with alendronate therapy for those diagnosed with osteoporosis is highly cost-effective for elderly women.

    PubMed

    Schousboe, John T; Ensrud, Kristine E; Nyman, John A; Melton, L Joseph; Kane, Robert L

    2005-10-01

    To investigate the cost-effectiveness of universal bone densitometry in women aged 65 and older combined with alendronate treatment for those diagnosed with osteoporosis (femoral neck T-score < or = -2.5). A Markov model with a lifetime time horizon and eight health states (no fracture, distal forearm fracture, radiographic (but clinically inapparent) vertebral fracture, clinical vertebral fracture, hip fracture, hip and vertebral fracture, and other fractures), using the societal perspective. Women living independently and those in nursing homes. Caucasian women aged 65, 75, 85, or 95. Bone densitometry of the hip, with 5 years of alendronate therapy for those found to have osteoporosis versus no intervention (densitometry or drug therapy). Lifetime accumulated quality adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios. The cost per QALY gained for the screen-and-treat strategy was 43,000 dollars per QALY gained for 65-year-old women and 5,600 dollars per QALY gained for 75-year-old women. For 85- and 95-year-old women, the screen-and-treat strategy was cost saving. Sensitivity analyses showed that the screen-and-treat strategy was cost-effective even under assumptions of reduced adherence to drug therapy, reduced fracture reduction benefit from alendronate therapy, or reduced QALYs saved by preventing fracture. Universal bone densitometry combined with alendronate therapy for those found to have osteoporosis is highly cost-effective for women aged 65 and older and may be cost saving for ambulatory women aged 85 and older (whether independently living or residing in nursing homes).

  1. Treatment outcome of patients with isoniazid mono-resistant tuberculosis.

    PubMed

    Chien, J-Y; Chen, Y-T; Wu, S-G; Lee, J-J; Wang, J-Y; Yu, C-J

    2015-01-01

    Isoniazid mono-resistance is the most common first-line drug resistance in tuberculosis (TB), but its treatment outcome remains unclear. From January 2004 to October 2011, 425 (5.1%) of 8414 patients with culture-confirmed pulmonary TB from four hospitals in Taiwan were identified as having isoniazid mono-resistant TB. Among them, 395 (92.9%) were included and followed up for 2 years after complete treatment. Although 328 (83.0%) patients were successfully treated, 67 (17.0%) had unfavourable outcomes, including death in 56 (14.2%) and treatment failure in 11 (2.8%). The treatment success rate was similar in patients with high-level and low-level isoniazid-resistant TB (82.2% versus 83.4%, p 0.785) and among those taking anti-TB treatment with and without isoniazid (83.1% versus 83.0%, p 1.000). Patients without rifampicin interruption had lower risk of unfavourable outcome (14.3% versus 37.0%, p <0.001), especially those with low-level isoniazid resistance (11.5% versus 56.5%, p <0.001). Supplementation with a new-generation fluoroquinolone improved treatment success (60.0% versus 12.5%, p 0.003). The presence of cavitary lesions was significantly associated with a higher relapse rate (4.1% versus 0.0%, p 0.006) and extended treatment of 7-9, 10-12 and >12 months had less relapse than 6-month treatment (3.2%, 0%, 3.7% and 25.0%, respectively, p 0.037). Multivariate Cox proportional hazards analysis revealed that co-morbidity with cancer (hazard ratio, 2.43) and rifampicin interruption (hazard ratio 1.91) were independent factors associated with unfavourable outcomes. Treatment throughout with rifampicin and extended treatment for cavitary disease are crucial for improving outcomes in patients with isoniazid mono-resistant TB.

  2. Psychosocial predictors of treatment outcome for trauma-affected refugees

    PubMed Central

    Sonne, Charlotte; Carlsson, Jessica; Bech, Per; Vindbjerg, Erik; Mortensen, Erik Lykke; Elklit, Ask

    2016-01-01

    Background The effects of treatment in trials with trauma-affected refugees vary considerably not only between studies but also between patients within a single study. However, we know little about why some patients benefit more from treatment, as few studies have analysed predictors of treatment outcome. Objective The objective of the study was to examine possible psychosocial predictors of treatment outcome for trauma-affected refugees. Method The participants were 195 adult refugees with posttraumatic stress disorder (PTSD) who were enrolled in a 6- to 7-month treatment programme at the Competence Centre for Transcultural Psychiatry (CTP), Denmark. The CTP Predictor Index used in the study included 15 different possible outcome predictors concerning the patients’ past, chronicity of mental health problems, pain, treatment motivation, prerequisites for engaging in psychotherapy, and social situation. The primary outcome measure was PTSD symptoms measured on the Harvard Trauma Questionnaire (HTQ). Other outcome measures included the Hopkins Symptom Check List-25, the WHO-5 Well-being Index, Sheehan Disability Scale, Hamilton Depression and Anxiety Scales, the somatisation scale of the Symptoms Checklist-90, Global Assessment of Functioning scales, and pain rated on visual analogue scales. The relations between treatment outcomes and the total score as well as subscores of the CTP Predictor Index were analysed. Results Overall, the total score of the CTP Predictor Index was significantly correlated to pre- to post treatment score changes on the majority of the ratings mentioned above. While employment status was the only single item significantly correlated to HTQ-score changes, a number of single items from the CTP Predictor Index correlated significantly with changes in depression and anxiety symptoms, but the size of the correlation coefficients were modest. Conclusions The total score of the CTP Predictor Index correlated significantly with outcomes on most

  3. Prevention of hypercalciuria and stone-forming propensity during prolonged bedrest by alendronate

    NASA Technical Reports Server (NTRS)

    Ruml, L. A.; Dubois, S. K.; Roberts, M. L.; Pak, C. Y.

    1995-01-01

    The bone loss and hypercalciuria induced by immobilization or the decreased gravitational forces of space are well described. Using a model of bedrest immobilization, the ability of a potent aminobisphosphonate, alendronate, to avert hypercalciuria and stone-forming propensity was tested. Sixteen male subjects participated in a randomized, placebo-controlled trial in which they received either 20 mg of alendronate or placebo 2 weeks prior to and during 3 weeks of strict bedrest. Parameters of bone and calcium metabolism and urinary crystallization of stone-forming salts were measured before and at the end of bedrest. In the placebo group, bedrest increased urinary calcium (209 +/- 47 to 267 +/- 60 mg/day, p < 0.01) and the saturation of calcium phosphate. Before bedrest, the alendronate group had a significantly lower serum calcium (8.8 +/- 0.4 vs. 9.6 +/- 0.5 mg/dl, p < 0.01) and higher serum PTH (62.4 +/- 33.1 vs. 23.1 +/- 7.5 pg/ml, p < 0.01) compared with the placebo group. Moreover, the alendronate group had a lower urinary calcium (75 +/- 41 mg/day) and saturation of calcium oxalate and calcium phosphate. These effects of alendronate were sustained during bedrest. Following bedrest in the alendronate group, urinary calcium rose to 121 +/- 50 mg/day, a value less than that in the placebo group before or during bedrest. Similarly, urinary saturation of calcium oxalate and calcium phosphate rose with bedrest in the alendronate-treated patients but remained lower than values obtained in placebo-treated patients before or during bedrest. Alendronate inhibits bone mineral loss and averts the hypercalciuria and increased propensity for the crystallization of stone-forming calcium salts which occurs during 3 weeks of strict bedrest.

  4. Effect of alendronate on endosseous implant integration: an in vivo study in rabbits.

    PubMed

    Chacon, Guillermo E; Stine, Eric A; Larsen, Peter E; Beck, F Michael; McGlumphy, Edwin A

    2006-07-01

    Alendronate sodium (Fosamax; Merck, Whitehouse Station, NJ) is a second-generation bisphosphonate used widely in osteopenic individuals for decreasing bone resorption and increasing bone density. The ability of alendronate to affect systemic bone remodeling raises natural questions about the drug's influence on dental implant osseointegration. Current knowledge regarding the effect of systemic bisphosphonates, specifically alendronate, on all 3 phrases of osseointegration is incomplete and only a few studies have started to investigate peri-implant bone responses to alendronate-coated implants. The purpose of this study was to determine the effect of systemic alendronate therapy on osseointegration of dental implants based on torque-removal values in rabbits. Identical titanium dental implants were placed using a standardized surgical protocol in the bilateral distal femur and proximal tibia of 20 New Zealand white rabbits (79 implants total). One week before implant placement, 10 rabbits were given doses of alendronate and continued on weekly dosing for 5 weeks until euthanized. The other 10 rabbits were untreated controls. Torque-removal values were determined using a Tohinichi 15-BTG torque wrench (Tohinichi Mfg Co, Ltd, Tokyo, Japan) for all implants. Analysis of torque data showed no statistical differences between the alendronate and control groups in both femur and tibia sites. A statistically significant difference, however, was noted in torque removal values between femur and tibia sites regardless of drug or non-drug groups. In summary, orally dosed alendronate administration in rabbits had no significant effect on dental implant torque-removal values 6 weeks after endosseous placement in femur and tibia.

  5. Prevention of hypercalciuria and stone-forming propensity during prolonged bedrest by alendronate

    NASA Technical Reports Server (NTRS)

    Ruml, L. A.; Dubois, S. K.; Roberts, M. L.; Pak, C. Y.

    1995-01-01

    The bone loss and hypercalciuria induced by immobilization or the decreased gravitational forces of space are well described. Using a model of bedrest immobilization, the ability of a potent aminobisphosphonate, alendronate, to avert hypercalciuria and stone-forming propensity was tested. Sixteen male subjects participated in a randomized, placebo-controlled trial in which they received either 20 mg of alendronate or placebo 2 weeks prior to and during 3 weeks of strict bedrest. Parameters of bone and calcium metabolism and urinary crystallization of stone-forming salts were measured before and at the end of bedrest. In the placebo group, bedrest increased urinary calcium (209 +/- 47 to 267 +/- 60 mg/day, p < 0.01) and the saturation of calcium phosphate. Before bedrest, the alendronate group had a significantly lower serum calcium (8.8 +/- 0.4 vs. 9.6 +/- 0.5 mg/dl, p < 0.01) and higher serum PTH (62.4 +/- 33.1 vs. 23.1 +/- 7.5 pg/ml, p < 0.01) compared with the placebo group. Moreover, the alendronate group had a lower urinary calcium (75 +/- 41 mg/day) and saturation of calcium oxalate and calcium phosphate. These effects of alendronate were sustained during bedrest. Following bedrest in the alendronate group, urinary calcium rose to 121 +/- 50 mg/day, a value less than that in the placebo group before or during bedrest. Similarly, urinary saturation of calcium oxalate and calcium phosphate rose with bedrest in the alendronate-treated patients but remained lower than values obtained in placebo-treated patients before or during bedrest. Alendronate inhibits bone mineral loss and averts the hypercalciuria and increased propensity for the crystallization of stone-forming calcium salts which occurs during 3 weeks of strict bedrest.

  6. Cigarette smoking and short-term addiction treatment outcome.

    PubMed

    Harrell, P T; Montoya, I D; Preston, K L; Juliano, L M; Gorelick, D A

    2011-06-01

    Cigarette smoking is common among patients in cocaine and opioid dependence treatment, and may influence treatment outcome. We addressed this issue in a secondary analysis of data from an outpatient clinical trial of buprenorphine treatment for concurrent cocaine and opioid dependence (13 weeks, N=200). The association between cigarette smoking (lifetime cigarette smoking status, number of cigarettes smoked per day prior to study entry) and short-term treatment outcome (% of urine samples positive for cocaine or opioids, treatment retention) was evaluated with analysis of covariance, bivariate correlations, and multivariate linear regression. Nicotine-dependent smokers (66% of participants) had a significantly higher percentage of cocaine-positive urine samples than non-smokers (12% of participants) (76% vs. 62%), but did not differ in percentage of opioid-positive urine samples or treatment retention. Number of cigarettes smoked per day at baseline was positively associated with percentage of cocaine-positive urine samples, even after controlling for baseline sociodemographic and drug use characteristics, but was not significantly associated with percentage of opioid-positive urine samples or treatment retention. These results suggest that cigarette smoking is associated with poorer short-term outcome of outpatient treatment for cocaine dependence, but perhaps not of concurrent opioid dependence, and support the importance of offering smoking cessation treatment to cocaine-dependent patients.

  7. Alendronate adherence and its impact on hip-fracture risk in patients with established osteoporosis in Taiwan.

    PubMed

    Lin, T-C; Yang, C-Y; Yang, Y-H Kao; Lin, S-J

    2011-07-01

    A pharmacoepidemiology study was conducted using the health insurance database in Taiwan to assess compliance with osteoporosis drug regimens and the impact of compliance on the risk for secondary fractures. Patients >50 years of age with vertebral/hip fracture who had been started on alendronate therapy for the first time only after the fracture were included. Compliance was measured using the medication possession ratio (MPR) and was included as a time-dependent covariate in the Cox model to compare the difference between compliant (MPR ≥ 80%) and noncompliant patients (MPR <80%) with respect to risk for subsequent hip fractures. Only 38% of the study population remained compliant during the first year of treatment. Over the 4-year follow-up period, the risk of hip fracture among the compliant patients was 70% lower than that among the noncompliant ones (adjusted hazard ratio (HR) 0.30). Among patients with osteoporosis in Taiwan who had experienced a fracture and had started alendronate therapy, compliance with the dosage regimen was suboptimal. It was also found that compliance significantly reduced the risk of secondary hip fracture up to 4 years.

  8. Feedback from Outcome Measures and Treatment Effectiveness, Treatment Efficiency, and Collaborative Practice: A Systematic Review.

    PubMed

    Gondek, Dawid; Edbrooke-Childs, Julian; Fink, Elian; Deighton, Jessica; Wolpert, Miranda

    2016-05-01

    Due to recent increases in the use of feedback from outcome measures in mental health settings, we systematically reviewed evidence regarding the impact of feedback from outcome measures on treatment effectiveness, treatment efficiency, and collaborative practice. In over half of 32 studies reviewed, the feedback condition had significantly higher levels of treatment effectiveness on at least one treatment outcome variable. Feedback was particularly effective for not-on-track patients or when it was provided to both clinicians and patients. The findings for treatment efficiency and collaborative practice were less consistent. Given the heterogeneity of studies, more research is needed to determine when and for whom feedback is most effective.

  9. Bone density around endosseous implants in patients taking alendronate: a pilot study.

    PubMed

    Griffiths, Garth R

    2012-06-01

    The purpose of this blind, randomized, controlled pilot investigation was to noninvasively determine bone mineral density (BMD) changes around endosseous implants placed in healthy patients who were administered the oral aminobisphosphonate alendronate. BMD was analyzed using computed tomography (CT) and grayscale imaging. Male patients (62 ± 12 years of age) were selected for placement of implants in a two-stage protocol. Patients requiring implants were initially seen for placement of half the total number of implants unilaterally in the maxilla or mandible, and each patient underwent a baseline CT scan. Six months from baseline, contralateral implants were placed with randomization into groups receiving 70 mg of alendronate weekly or a placebo, and a second CT scan was completed. Alendronate/placebo was discontinued after 6 months, and a CT scan was completed at 12 months. Patients returned for an exit evaluation and CT scan at 18 months. Hounsfield units were measured at implant placement and nonsurgical sites in the maxilla and mandible. Within the limitations of this study, results included: a decreasing trend in BMD surrounding an implant when alendronate was administered for 6 months starting at the time of implant placement, a less evident decreasing trend in BMD surrounding an implant when alendronate was administered for 6 months after the implant had successfully undergone osseointegration, and a trend suggesting BMD "rebound" when alendronate was discontinued for 6 months after initial drug administration starting either at the time of implant placement or after the implant had successfully undergone osseointegration for 6 months.

  10. Treatment outcome and its predictors among Asian problem drinkers.

    PubMed

    Manning, Victoria; Gomez, Brenda; Koh, Puay Kee; Ng, Andrew; Guo, Song; Kandasami, Gomathinayagam; Wong, Kim Eng

    2013-03-01

    Evidence of treatment effectiveness for alcohol use disorders (AUD) have emerged predominantly from Western studies, using highly controlled trials that may not reflect real-world settings. This paper examines treatment outcome and its predictors among Asian problem drinkers participating in a treatment outcome monitoring program at an addiction treatment centre in Singapore. Data were collected at intake and 3, 6 and 12 months, although the focus of this paper is on reliable change at 3 months among the 70% who were followed up. Five hundred and forty-one AUD-diagnosed outpatients presenting for treatment, over a 2-year period, were assessed on drinking behaviours and administered the Addiction Severity Index-Lite, Personal Wellbeing Index (PWI) and Treatment Perceptions Questionnaire. At 3 months, drinking days, alcohol units and alcohol use severity had more than halved and 69% were either abstinent or had reliably reduced their drinking days. Baseline drinking days and treatment satisfaction predicted 3-month drinking frequency but not severity. Positive alcohol outcomes observed at 3 months were sustained among those followed up until 12 months. Mean PWI score improved significantly and fell within the 'normal' range. Treatment satisfaction also emerged as the only significant predictor of reliable positive change in both drinking days and PWI score. Significant reductions in drinking frequency and severity are possible for Asian problem drinkers after 12 weeks of outpatient treatment. The identified predictors suggest that more frequent drinkers and patients with past/current psychiatric comorbidities may require a more intensive treatment approach to optimise treatment outcomes. © 2012 Australasian Professional Society on Alcohol and other Drugs.

  11. Treatment process, alliance and outcome in brief versus extended treatments for marijuana dependence

    PubMed Central

    Gibbons, Carly J.; Nich, Charla; Steinberg, Karen; Roffman, Roger A.; Corvino, Joanne; Babor, Thomas F.; Carroll, Kathleen M.

    2012-01-01

    Aims The Marijuana Treatment Project, a large multi-site randomized clinical trial, compared a delayed treatment control condition with a brief (two-session) and extended (nine-session) multi-component treatment among 450 marijuana-dependent participants. In this report we present treatment process data, including the fidelity of treatment delivery in the three community-based treatment settings as well as the relationships between treatment process and outcome. Design Independent evaluations of clinician adherence and competence ratings were made based on 633 videotaped sessions from 163 participants. Relationships between clinician adherence and competence, ratings of the working alliance and marijuana treatment outcomes were evaluated. Findings Protocol treatments were implemented with strong fidelity to manual specifications and with few significant differences in adherence and competence ratings across sites. In the brief two-session treatment condition, only the working alliance was associated significantly with frequency of marijuana use, but in the extended treatment therapist ratings of working alliance predicted outcomes, as did the interaction of alliance and curvilinear adherence. Conclusions Behavioral treatments for marijuana use were delivered in community settings with good fidelity. Participant and therapist working alliance scores were associated significantly with improved marijuana use outcomes in a brief behavioral treatment for adults with marijuana dependence. In extended treatment the therapist ratings of working alliance were associated with more positive outcome. However, in that treatment there was also a significant interaction between alliance and curvilinear adherence. PMID:20840200

  12. Diagnostic PET Imaging of Mammary Microcalcifications Using (64)Cu-DOTA-Alendronate in a Rat Model of Breast Cancer.

    PubMed

    Ahrens, Bradley J; Li, Lin; Ciminera, Alexandra K; Chea, Junie; Poku, Erasmus; Bading, James R; Weist, Michael R; Miller, Marcia M; Colcher, David M; Shively, John E

    2017-09-01

    The development of improved breast cancer screening methods is hindered by a lack of cancer-specific imaging agents and effective small-animal models to test them. The purpose of this study was to evaluate (64)Cu-DOTA-alendronate as a mammary microcalcification-targeting PET imaging agent, using an ideal rat model. Our long-term goal is to develop (64)Cu-DOTA-alendronate for the detection and noninvasive differentiation of malignant versus benign breast tumors with PET. Methods: DOTA-alendronate was synthesized, radiolabeled with (64)Cu, and administered to normal or tumor-bearing aged, female, retired breeder Sprague-Dawley rats for PET imaging. Mammary tissues were subsequently labeled and imaged with light, confocal, and electron microscopy to verify microcalcification targeting specificity of DOTA-alendronate and elucidate the histologic and ultrastructural characteristics of the microcalcifications in different mammary tumor types. Tumor uptake, biodistribution, and dosimetry studies were performed to evaluate the efficacy and safety of (64)Cu-DOTA-alendronate. Results:(64)Cu-DOTA-alendronate was radiolabeled with a 98% yield. PET imaging using aged, female, retired breeder rats showed specific binding of (64)Cu-DOTA-alendronate in mammary glands and mammary tumors. The highest uptake of (64)Cu-DOTA-alendronate was in malignant tumors and the lowest uptake in benign tumors and normal mammary tissue. Confocal analysis with carboxyfluorescein-alendronate confirmed the microcalcification binding specificity of alendronate derivatives. Biodistribution studies revealed tissue alendronate concentrations peaking within the first hour, then decreasing over the next 48 h. Our dosimetric analysis demonstrated a (64)Cu effective dose within the acceptable range for clinical PET imaging agents and the potential for translation into human patients. Conclusion:(64)Cu-DOTA-alendronate is a promising PET imaging agent for the sensitive and specific detection of mammary tumors

  13. Social cognitive predictors of treatment outcome in cannabis dependence.

    PubMed

    Gullo, Matthew J; Matveeva, Marya; Feeney, Gerald F X; Young, Ross McD; Connor, Jason P

    2017-01-01

    Drug-related outcomes expectancies and refusal self-efficacy are core components of Social Cognitive Theory. Both predict treatment outcome in alcohol use disorders. Few studies have reported expectancies and refusal self-efficacy in cannabis dependence. None have examined both, although both constructs are key targets in Cognitive-Behavioural Therapy (CBT). This study tests the predictive role of expectancies and refusal self-efficacy in treatment outcome for cannabis dependence. Outpatients completed a comprehensive assessment when commencing cannabis treatment and predictors of treatment outcome were tested. A university hospital alcohol and drug outpatient clinic. 221 cannabis-dependent patients participated in a 6-week CBT program where the goal was abstinence. Cannabis Expectancy Questionnaire and Cannabis Refusal Self-Efficacy Questionnaire, cannabis dependence severity [Severity of Dependence Scale], psychological distress [General Health Questionnaire] at baseline; the timeline follow-back procedure at baseline and each session. Patients reporting lower confidence in their ability to resist cannabis during high negative affect (emotional relief refusal self-efficacy) had a lower likelihood of abstinence (p=0.004), more days of use (p<0.001), and larger amount used (p<0.001). Negative cannabis expectancies predicted greater likelihood of abstinence (p=0.024). Higher positive expectancies were associated with lower emotional relief self-efficacy, mediating its association with outcome (p<0.001). Emotional relief refusal self-efficacy and negative expectancies are predictive of better treatment outcomes for cannabis dependence. Positive expectancies may indirectly predict poorer outcome because of a negative association with self-efficacy, but this conclusion remains tentative as directionality could not be established. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  14. Juvenile kyphosis: effects of different variables on conservative treatment outcome.

    PubMed

    Platero, D; Luna, J D; Pedraza, V

    1997-09-01

    We reviewed the records of 212 patients with idiopathic or Scheuermann-type juvenile kyphosis (Scheuermann's disease). The 200 patients available for follow-up were divided into three groups depending on the degree of angular deformity, and the influence of different variables on treatment outcome in each group was investigated. A very influential positive variable was combined treatment with a body cast plus brace; exercise treatment also produced acceptable results. Other variables that positively influenced the outcome of treatment were compliance with treatment, and (unexpectedly) elevated initial Risser sign (skeletal maturity). An initial Risser sign of 0 or 1 was, in contrast with other studies, associated with smaller improvement. However, initial maximal wedging, etiology and initial assessment of curve flexibility did not influence the degree of improvement in the initial angular deformity.

  15. Adolescent tobacco use and substance abuse treatment outcomes.

    PubMed

    de Dios, Marcel A; Vaughan, Ellen L; Stanton, Cassandra A; Niaura, Raymond

    2009-07-01

    This study investigated the relationship between cigarette-smoking status and 12-month alcohol and marijuana treatment outcomes in a sample of 1,779 adolescents from the Drug Abuse Treatment Outcomes Study for Adolescents. Participants were classified into four groups based on change in cigarette-smoking status from intake to the 12-month follow-up: persistent smokers, nonsmokers, quitters, and smoking initiators. Logistic regression was used to predict likelihood of relapse to alcohol, marijuana, and other drugs after controlling for intake levels and demographic/treatment characteristics. Results found persistent smokers and smoking initiators to have significantly greater odds of alcohol and marijuana relapse compared with quitters. Furthermore, persistent smokers and smoking initiators were also found to have distinctively shorter periods to marijuana relapse at follow-up. Implications for the implementation of tobacco cessation treatment in the context of substance abuse treatment for adolescents are discussed.

  16. Adolescent Tobacco Use and Substance Abuse Treatment Outcomes

    PubMed Central

    de Dios, Marcel A.; Vaughan, Ellen L.; Stanton, Cassandra A.; Niaura, Raymond

    2009-01-01

    This study investigated the relationship between cigarette smoking status and 12-month alcohol and marijuana treatment outcomes in a sample of 1779 adolescents from the Drug Abuse Treatment Outcomes Study for Adolescence (DATOS-A). Participants were classified into 4 groups based on change in cigarette smoking status from intake to the 12-month follow-up: Persistent Smokers, Non-Smokers, Quitters, and Smoking Initiators. Logistic regression was used to predict likelihood of relapse to alcohol, marijuana, and other drugs after controlling for intake levels and demographic/treatment characteristics. Results found Persistent Smokers and Smoking Initiators to have significantly greater odds of alcohol and marijuana relapse compared to Quitters. Furthermore, Persistent Smokers, and Smoking Initiators were also found to have distinctively shorter periods of time to marijuana relapse at follow-up. Implications for the implementation of tobacco cessation treatment in the context of substance abuse treatment for adolescents are discussed. PMID:19004603

  17. ENGAGEMENT IN OUTPATIENT SUBSTANCE ABUSE TREATMENT AND EMPLOYMENT OUTCOMES

    PubMed Central

    Dunigan, Robert; Acevedo, Andrea; Campbell, Kevin; Garnick, Deborah W.; Horgan, Constance M.; Huber, Alice; Lee, Margaret T.; Panas, Lee; Ritter, Grant A.

    2013-01-01

    This study, a collaboration between an academic research center and Washington State’s health, employment and correction departments, investigates the extent to which treatment engagement, a widely adopted performance measure, is associated with employment, an important outcome for individuals receiving treatment for substance use disorders. Two-stage Heckman probit regressions were conducted using 2008 administrative data for 7,570 adults receiving publicly-funded treatment. The first stage predicted employment in the year following the first treatment visit and three separate second stages models predicted number of quarters employed, wages, and hours worked. Engagement as a main effect was not significant for any of the employment outcomes. However, for clients with prior criminal justice involvement, engagement was associated with both employment and higher wages following treatment. Clients with criminal justice involvement face greater challenge regarding employment, so the identification of any actionable step which increases the likelihood of employment or wages is an important result. PMID:23686216

  18. Disintegration/dissolution profiles of copies of Fosamax (alendronate).

    PubMed

    Epstein, S; Cryer, B; Ragi, S; Zanchetta, J R; Walliser, J; Chow, J; Johnson, M A; Leyes, A E

    2003-01-01

    Poor quality has been reported for some generics and other copies of original products. We performed a pilot study to compare the disintegration/dissolution profiles of FOSAMAX (alendronate) 70 mg tablets with those of copies of FOSAMAX that were manufactured outside the United States. We used the standard United States Pharmacopeia (USP) disintegration method to evaluate FOSAMAX 70 mg tablets and 13 copies. At least 12 (n = 12) dosage units were tested for each product (except Fosmin, n = 10). The dissolution profiles of FOSAMAX and one representative copy were also compared. Nine copies (Osteomax, Defixal, Fosmin, Endronax, Osteomix, Genalmen, Fixopan, Osteoplus, and Fosval) disintegrated two- to ten-fold faster than FOSAMAX. Three other copies (Neobon, Regenesis, and Ostenan) disintegrated at least five-fold slower than FOSAMAX. Neobon is a softgel capsule, so special consideration was given to this different dosage form. One copy (Arendal) did not fall into either category but exhibited potentially large inter- and intra-lot variability. Dissolution of alendronate from Regenesis lagged behind that from FOSAMAX. Slower disintegration may reduce efficacy because bisphosphonates must be taken in the fasting state and contact with food or even certain beverages severely reduces bioavailability. Faster disintegration (or the use of gel-caps or other alterations to the drug formulation) could increase the risk of esophagitis, an adverse event associated with prolonged contact of the esophagus with bisphosphonates. These disintegration and dissolution results suggest that important differences may exist between FOSAMAX and its copies with regard to bioavailability, pharmacokinetics, and clinical efficacy and safety profiles. Additional testing is warranted to evaluate the pharmacokinetics and clinical safety of these copies.

  19. Relationships between Treatment Expectations and Treatment Outcomes among Outpatients with Substance Use Problems

    ERIC Educational Resources Information Center

    Raylu, Namrata; Kaur, Inderjit

    2012-01-01

    Currently, studies exploring the relationship between treatment expectations (TE) and outcome among individuals with substance use problems are significantly lacking. This is important as relapse and attrition rates among this group are greater than those with other psychological problems. Understanding how TE impact treatment outcomes among this…

  20. Relationships between Treatment Expectations and Treatment Outcomes among Outpatients with Substance Use Problems

    ERIC Educational Resources Information Center

    Raylu, Namrata; Kaur, Inderjit

    2012-01-01

    Currently, studies exploring the relationship between treatment expectations (TE) and outcome among individuals with substance use problems are significantly lacking. This is important as relapse and attrition rates among this group are greater than those with other psychological problems. Understanding how TE impact treatment outcomes among this…

  1. Treatment Outcome of Patients with Buruli Ulcer Disease in Togo

    PubMed Central

    Beissner, Marcus; Arens, Nathalie; Wiedemann, Franz; Piten, Ebekalisaï; Kobara, Basile; Bauer, Malkin; Herbinger, Karl-Heinz; Badziklou, Kossi; Banla Kere, Abiba; Löscher, Thomas; Nitschke, Jörg; Bretzel, Gisela

    2015-01-01

    Background Following introduction of antimycobacterial treatment of Buruli ulcer disease (BUD), several clinical studies evaluated treatment outcomes of BUD patients, in particular healing times, secondary lesions and functional limitations. Whereas recurrences were rarely observed, paradoxical reactions and functional limitations frequently occurred. Although systematic BUD control in Togo was established as early as 2007, treatment outcome has not been reviewed to date. Therefore, a pilot project on post-treatment follow-up of BUD patients in Togo aimed to evaluate treatment outcomes and to provide recommendations for optimization of treatment success. Methodology/Principal Findings Out of 199 laboratory confirmed BUD patients, 129 could be enrolled in the study. The lesions of 109 patients (84.5%) were completely healed without any complications, 5 patients (3.9%) had secondary lesions and 15 patients (11.6%) had functional limitations. Edema, category III ulcers >15cm, healing times >180 days and a limitation of movement at time of discharge constituted the main risk factors significantly associated with BUD related functional limitations (P<0.01). Review of all BUD related documentation revealed major shortcomings, in particular concerning medical records on adjuvant surgical and physiotherapeutic treatment. Conclusions/Significance This study presents the first systematic analysis of treatment outcome of BUD patients from Togo. Median times to healing and the absence of recurrences were in line with findings reported by other investigators. The percentage of functional limitations of 11.6% was lower than in other studies, and edema, category III ulcers, healing time >180 days and limitation of movement at discharge constituted the main risk factors for functional limitations in Togolese BUD patients. Standardized treatment plans, patient assessment and follow-up, as well as improved management of medical records are recommended to allow for intensified

  2. Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

    PubMed

    Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf

    2016-07-01

    The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. Barriers to Implementing Treatment Integrity Procedures: Survey of Treatment Outcome Researchers

    ERIC Educational Resources Information Center

    Perepletchikova, Francheska; Hilt, Lori M.; Chereji, Elizabeth; Kazdin, Alan E.

    2009-01-01

    Treatment integrity refers to implementing interventions as intended. Treatment integrity is critically important for experimental validity and for drawing valid inferences regarding the relationship between treatment and outcome. Yet, it is rarely adequately addressed in psychotherapy research. The authors examined barriers to treatment integrity…

  4. Isolated polycystic morphology: Does it affect the IVF treatment outcomes?

    PubMed

    Bezirganoglu, N; Seckin, K D; Baser, E; Karsli, M F; Yeral, M I; Cicek, M N

    2015-04-01

    The aim of the current study was to compare women who have normal ovarian ultrasonographic findings and women with ovulatory polycystic ovary (PCO), in terms of IVF treatment outcome. The study was conducted at a tertiary referral hospital and included 906 women who underwent IVF treatment. Of these, 224 of the women had PCO (24.7%) and 682 of the women had normal ovarian morphology (75.3%) at the time of ultrasonographic examination prior to IVF. The treatment outcomes were compared between the two groups. In the PCO group, the number of oocytes at the size of > 16 mm, the overall number of collected oocytes and the number of fertilised oocytes were found to be significantly higher. Furthermore, the rates of implantation, biochemical pregnancy and clinical pregnancy were significantly higher in the PCO group (p < 0.05). The detection of PCO morphology on baseline ultrasonography in IVF candidates may be associated with higher treatment success.

  5. Suicidality and Its Relationship to Treatment Outcome in Depressed Adolescents

    ERIC Educational Resources Information Center

    Barbe, Remy P.; Bridge, Jeffrey; Birmaher, Boris; Kolko, David; Brent, David A.

    2004-01-01

    This study investigates the impact of suicidality on treatment outcome in 107 depressed adolescents who participated in a clinical trial, and received either cognitive-behavioral (CBT), systemic-behavioral-family (SBFT), or non-directive-supportive therapy (NST). Suicidal depressed adolescents had a higher dropout rate and were more likely to be…

  6. Methodological Considerations in Treatment Outcome Research on Obesity.

    ERIC Educational Resources Information Center

    Wilson, G. Terence

    1978-01-01

    Describes common methodological inadequacies in research on treatment of obesity and suggests alternatives. Importance of multiple measurement of outcome is emphasized. Merits of alternative single-subject and between-groups experimental designs are discussed. Reasons for conspicuous lack of long-term follow-ups are analyzed. Recommendations for…

  7. Alliance, Technology, and Outcome in the Treatment of Anxious Youth

    ERIC Educational Resources Information Center

    Chu, Brian C.; Choudhury, Muniya S.; Shortt, Alison L.; Pincus, Donna B.; Creed, Torrey A.; Kendall, Philip C.

    2004-01-01

    A strong therapeutic alliance is intuitively important in a cognitive-behavioral treatment of anxious youth where the child must confront feared stimuli in numerous exposure tasks. Research examining alliance-outcome relationships and the specific role of the alliance is currently limited. Is the alliance supportive in nature, does it enhance…

  8. The Effects of Drinking Goal on Treatment Outcome for Alcoholism

    ERIC Educational Resources Information Center

    Bujarski, Spencer; O'Malley, Stephanie S.; Lunny, Katy; Ray, Lara A.

    2013-01-01

    Objective: It is well known to clinicians and researchers in the field of alcoholism that patients vary with respect to drinking goal. The objective in this study was to elucidate the contribution of drinking goal to treatment outcome in the context of specific behavioral and pharmacological interventions. Method: Participants were 1,226…

  9. The Effects of Drinking Goal on Treatment Outcome for Alcoholism

    ERIC Educational Resources Information Center

    Bujarski, Spencer; O'Malley, Stephanie S.; Lunny, Katy; Ray, Lara A.

    2013-01-01

    Objective: It is well known to clinicians and researchers in the field of alcoholism that patients vary with respect to drinking goal. The objective in this study was to elucidate the contribution of drinking goal to treatment outcome in the context of specific behavioral and pharmacological interventions. Method: Participants were 1,226…

  10. Functional Outcomes in the Treatment of Adults with ADHD

    ERIC Educational Resources Information Center

    Adler, Lenard A.; Spencer, Thomas J.; Levine, Louise R.; Ramsey, Janet L.; Tamura, Roy; Kelsey, Douglas; Ball, Susan G.; Allen, Albert J.; Biederman, Joseph

    2008-01-01

    Objective: ADHD is associated with significant functional impairment in adults. The present study examined functional outcomes following 6-month double-blind treatment with either atomoxetine or placebo. Method: Patients were 410 adults (58.5% male) with "DSM-IV"--defined ADHD. They were randomly assigned to receive either atomoxetine 40 mg/day to…

  11. Psychophysiological Outcome of Behavioral and Pharmacological Treatments of Agoraphobia.

    ERIC Educational Resources Information Center

    Michelson, Larry; Mavissakalian, Matig

    1985-01-01

    Examined relative and combined effectiveness of behavior therapy and pharmacotherapy in 62 severe, chronic agoraphobics. Identified differential temporal response and treatment patterns across psychophysiological domains. Synchrony/desynchrony phenomena yielded significant findings with regard to process and clinical outcome status. Exploratory…

  12. Functional Outcomes in the Treatment of Adults with ADHD

    ERIC Educational Resources Information Center

    Adler, Lenard A.; Spencer, Thomas J.; Levine, Louise R.; Ramsey, Janet L.; Tamura, Roy; Kelsey, Douglas; Ball, Susan G.; Allen, Albert J.; Biederman, Joseph

    2008-01-01

    Objective: ADHD is associated with significant functional impairment in adults. The present study examined functional outcomes following 6-month double-blind treatment with either atomoxetine or placebo. Method: Patients were 410 adults (58.5% male) with "DSM-IV"--defined ADHD. They were randomly assigned to receive either atomoxetine 40 mg/day to…

  13. Suicidality and Its Relationship to Treatment Outcome in Depressed Adolescents

    ERIC Educational Resources Information Center

    Barbe, Remy P.; Bridge, Jeffrey; Birmaher, Boris; Kolko, David; Brent, David A.

    2004-01-01

    This study investigates the impact of suicidality on treatment outcome in 107 depressed adolescents who participated in a clinical trial, and received either cognitive-behavioral (CBT), systemic-behavioral-family (SBFT), or non-directive-supportive therapy (NST). Suicidal depressed adolescents had a higher dropout rate and were more likely to be…

  14. Predicting Future Clinical Adjustment from Treatment Outcome and Process Variables.

    ERIC Educational Resources Information Center

    Patterson, G. R.; Forgatch, Marion S.

    1995-01-01

    Issues related to the use of outcome and process data from the treatment of antisocial children to predict future childhood adjustment were examined through a study of 69 children. Data supported the hypothesis that measures of processes thought to produce changes in child behavior would serve to predict future adjustment. (SLD)

  15. Duration-dependent effects of clinically relevant oral alendronate doses on cortical bone toughness in beagle dogs

    PubMed Central

    Burr, David B.; Liu, Ziyue; Allen, Matthew R.

    2014-01-01

    Bisphosphonates (BPs) have been shown to significantly reduce bone toughness in vertebrae within one year when given at clinical doses to dogs. Although BPs also reduce toughness in cortical bone when given at high doses, their effect on cortical bone material properties when given at clinical doses is less clear. In part, this may be due to the use of small sample sizes that were powered to demonstrate differences in bone mineral density rather than bone’s material properties. Our lab has conducted several studies in which dogs were treated with alendronate at a clinically relevant dose. The goal of this study was to examine these published and unpublished data collectively to determine whether there is a significant time-dependent effect of alendronate on toughness of cortical bone. This analysis seemed particularly relevant given the recent occurrence of atypical femoral fractures in humans. Differences in the toughness of ribs taken from dogs derived from five separate experiments were measured. The dogs were orally administered saline (CON, 1 ml/kg/day) or alendronate (ALN) at a clinical dose (0.2 mg/kg/day). Treatment duration ranged from 3 months to 3 years. Groups were compared using ANOVA, and time trends analyzed with linear regression analysis. Linear regressions of the percent difference in toughness between CON and ALN at each time point revealed a significant reduction in toughness with longer exposure to ALN. The downward trend was primarily driven by a downward trend in post-yield toughness, whereas toughness in the pre-yield region was not changed relative to CON. These data suggest that a longer duration of treatment with clinical doses of ALN results in deterioration of cortical bone toughness in a time-dependent manner. As the duration of treatment is lengthened, the cortical bone exhibits increasingly brittle behavior. This may be important in assessing the role that long-term BP treatments play in the risk of atypical fractures of femoral

  16. Duration-dependent effects of clinically relevant oral alendronate doses on cortical bone toughness in beagle dogs.

    PubMed

    Burr, David B; Liu, Ziyue; Allen, Matthew R

    2015-02-01

    Bisphosphonates (BPs) have been shown to significantly reduce bone toughness in vertebrae within one year when given at clinical doses to dogs. Although BPs also reduce toughness in the cortical bone when given at high doses, their effect on cortical bone material properties when given at clinical doses is less clear. In part, this may be due to the use of small sample sizes that were powered to demonstrate differences in bone mineral density rather than the bone's material properties. Our lab has conducted several studies in which dogs were treated with alendronate at a clinically relevant dose. The goal of this study was to examine these published and unpublished data collectively to determine whether there is a significant time-dependent effect of alendronate on toughness of the cortical bone. This analysis seemed particularly relevant given the recent occurrence of atypical femoral fractures in humans. Differences in the toughness of ribs taken from dogs derived from five separate experiments were measured. The dogs were orally administered saline (CON, 1ml/kg/day) or alendronate (ALN) at a clinical dose (0.2mg/kg/day). Treatment duration ranged from 3months to 3years. Groups were compared using ANOVA, and time trends analyzed with linear regression analysis. Linear regressions of the percent difference in toughness between CON and ALN at each time point revealed a significant reduction in toughness with longer exposure to ALN. The downward trend was primarily driven by a downward trend in post-yield toughness, whereas toughness in the pre-yield region was not changed relative to CON. These data suggest that a longer duration of treatment with clinical doses of ALN results in deterioration of cortical bone toughness in a time-dependent manner. As the duration of treatment is lengthened, the cortical bone exhibits increasingly brittle behavior. This may be important in assessing the role that long-term BP treatments play in the risk of atypical fractures of the

  17. Cluster analysis and prediction of treatment outcomes for chronic rhinosinusitis.

    PubMed

    Soler, Zachary M; Hyer, J Madison; Rudmik, Luke; Ramakrishnan, Viswanathan; Smith, Timothy L; Schlosser, Rodney J

    2016-04-01

    Current clinical classifications of chronic rhinosinusitis (CRS) have weak prognostic utility regarding treatment outcomes. Simplified discriminant analysis based on unsupervised clustering has identified novel phenotypic subgroups of CRS, but prognostic utility is unknown. We sought to determine whether discriminant analysis allows prognostication in patients choosing surgery versus continued medical management. A multi-institutional prospective study of patients with CRS in whom initial medical therapy failed who then self-selected continued medical management or surgical treatment was used to separate patients into 5 clusters based on a previously described discriminant analysis using total Sino-Nasal Outcome Test-22 (SNOT-22) score, age, and missed productivity. Patients completed the SNOT-22 at baseline and for 18 months of follow-up. Baseline demographic and objective measures included olfactory testing, computed tomography, and endoscopy scoring. SNOT-22 outcomes for surgical versus continued medical treatment were compared across clusters. Data were available on 690 patients. Baseline differences in demographics, comorbidities, objective disease measures, and patient-reported outcomes were similar to previous clustering reports. Three of 5 clusters identified by means of discriminant analysis had improved SNOT-22 outcomes with surgical intervention when compared with continued medical management (surgery was a mean of 21.2 points better across these 3 clusters at 6 months, P < .05). These differences were sustained at 18 months of follow-up. Two of 5 clusters had similar outcomes when comparing surgery with continued medical management. A simplified discriminant analysis based on 3 common clinical variables is able to cluster patients and provide prognostic information regarding surgical treatment versus continued medical management in patients with CRS. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All

  18. Real-Life and RCT Participants: Alendronate Users Versus FITs' Trial Eligibility Criterion.

    PubMed

    Reyes, Carlen; Pottegård, Anton; Schwarz, Peter; Javaid, M Kassim; Van Staa, Tjeerd P; Cooper, Cyrus; Diez-Perez, Adolfo; Abrahamsen, Bo; Prieto-Alhambra, Daniel

    2016-09-01

    We aimed to characterize incident users of alendronate from Denmark and Spain, and investigate their eligibility for participation in the pivotal Fracture Intervention Trial (FIT). This is an international cross-sectional study, where the data were obtained from the SIDIAP database (Sistema d'Informació per al Desenvolupament de l'Investigació en Atenció Primària) from Catalonia (Spain) and the Danish Health Registries (DHR). This study included patients who were incident users of alendronate, ≥40 years old with no history of Paget's disease. Our measurements were the proportion of incident users of alendronate who were not eligible to participate in FIT. 14,316 and 21,221 subjects initiated alendronate in 2006-2007 (SIDIAP) and 2005-2006 (DHR), respectively. SIDIAP and DHR alendronate user cohorts had 2347 (16.4 %) and 5275 (24.9 %) subjects aged >80 years old, reported 9 (0.1 %) and 91 (0.4 %) diagnoses of myocardial infarction, 423 (3 %) and 368 (1.7 %) of erosive gastro-intestinal disease, 200 (1.4 %) and 1109 (5.2 %) of dyspepsia, and 349 (2.4 %) and 149 (0.7 %) of metabolic bone disease, all of which were exclusion criteria in FIT. Men [3818 (26.7 %) in SIDIAP and 3885 (18.3 %) in DHR] and glucocorticoid users [1229 (8.6 %) in SIDIAP and 4716 (22.2 %) in DHR] were also excluded from the FIT trial. Overall, 3447 (35.4 %) SIDIAP and 6228 (44.5 %) (when not considering men and glucocorticoid users) DHR of incident alendronate users would have been excluded from FIT. One in two real-life users of alendronate exhibited one or more clinical characteristics that would have led to them being excluded from the FIT trial.

  19. Bisphosphonate action. Alendronate localization in rat bone and effects on osteoclast ultrastructure.

    PubMed Central

    Sato, M; Grasser, W; Endo, N; Akins, R; Simmons, H; Thompson, D D; Golub, E; Rodan, G A

    1991-01-01

    Studies of the mode of action of the bisphosphonate alendronate showed that 1 d after the injection of 0.4 mg/kg [3H]alendronate to newborn rats, 72% of the osteoclastic surface, 2% of the bone forming, and 13% of all other surfaces were densely labeled. Silver grains were seen above the osteoclasts and no other cells. 6 d later the label was 600-1,000 microns away from the epiphyseal plate and buried inside the bone, indicating normal growth and matrix deposition on top of alendronate-containing bone. Osteoclasts from adult animals, infused with parathyroid hormone-related peptide (1-34) and treated with 0.4 mg/kg alendronate subcutaneously for 2 d, all lacked ruffled border but not clear zone. In vitro alendronate bound to bone particles with a Kd of approximately 1 mM and a capacity of 100 nmol/mg at pH 7. At pH 3.5 binding was reduced by 50%. Alendronate inhibited bone resorption by isolated chicken or rat osteoclasts when the amount on the bone surface was around 1.3 x 10(-3) fmol/microns 2, which would produce a concentration of 0.1-1 mM in the resorption space if 50% were released. At these concentrations membrane leakiness to calcium was observed. These findings suggest that alendronate binds to resorption surfaces, is locally released during acidification, the rise in concentration stops resorption and membrane ruffling, without destroying the osteoclasts. Images PMID:1661297

  20. Raloxifene but not alendronate can compensate the impaired osseointegration in osteoporotic rats.

    PubMed

    Faverani, Leonardo Perez; Polo, Tárik Ocon Braga; Ramalho-Ferreira, Gabriel; Momesso, Gustavo Antonio Correa; Hassumi, Jaqueline Suemi; Rossi, Ana Cláudia; Freire, Alexandre Rodrigues; Prado, Felippe Bevilacqua; Luvizuto, Eloá Rodrigues; Gruber, Reinhard; Okamoto, Roberta

    2017-03-29

    Alendronate and raloxifene, a bisphosphonate and a selective estrogen modulator, respectively, are established osteoporosis therapies. Current evidence suggests that simultaneous application of osteoporosis therapies modulates osseointegration. However, alendronate shows inconsistent findings and raloxifene has not been studied comprehensively. This study aimed to evaluate the bone dynamics and molecular and microstructural features at the peri-implant bone interface in osteoporotic rats. Thirty female rats underwent ovariectomy and were fed a diet low in calcium and phosphate and treated with alendronate or raloxifene for 30 days or underwent fictional ovariectomy surgery (SHAM) prior to implant insertion in the tibia; osteoporosis therapies continued thereafter. After 42 days, peri-implant bone was evaluated by histometric and micro-CT analysis. Fluorochrome incorporation and gene expression was determined to evaluate bone turnover. We report here that alendronate had no impact on bone-to-implant contacts and the mineral apposition rate. The RANKL/OPG ratio and local bone volume, however, were increased compared to the untreated osteoporotic rats. Even though signaling to bone resorption activity through RANKL production was observed in the alendronate group, the blockade of bone resorption activity that occurs in decorrence to alendronate activity took place and resulted in an increase in bone volume. Raloxifene significantly increased osseointegration in osteoporotic rats, as indicated by bone-to-implant contacts, mineral apposition, and local bone volume. Raloxifene, however, had no considerable impact on the RANKL/OPG ratio compared to untreated osteoporotic rats. As expected, the SH group showed higher bone-to-implant contacts and mineral apposition rates than the untreated osteoporotic rats. These findings suggest that raloxifene but not alendronate can compensate for the impaired osseointegration in osteoporotic rats. Regarding the superiority of

  1. Treatment Patterns and Outcomes in Patients with Varicose Veins.

    PubMed

    Mallick, Rajiv; Raju, Aditya; Campbell, Chelsey; Carlton, Rashad; Wright, David; Boswell, Kimberly; Eaddy, Michael

    2016-11-01

    Approximately 24% of adults in the United States have visible varicose veins, and an estimated 6% have evidence of advanced chronic venous disease. The majority of individuals with varicose veins seek treatment because of symptoms, such as aching, throbbing, fatigue, pruritus, ankle swelling, and tenderness, rather than cosmetic reasons. Furthermore, varicose veins are a manifestation of chronic venous insufficiency, which can progress to leg pain, leg edema, chronic skin changes, and nonhealing ulcers. To assess varicose vein treatment patterns and their corresponding outcomes, including additional treatment rates, disease progression to new ulcers, and associated costs from a US perspective. We conducted a retrospective claims database study using data from the Truven Health MarketScan database. Adults who were newly diagnosed with varicose veins between January 1, 2008, and June 30, 2010, and met the study inclusion criteria were eligible to participate and were divided into 6 cohorts based on the type of first or initial therapy they received after the index diagnosis date, including surveillance and compression therapy, surgery, laser ablation, radiofrequency ablation, sclerotherapy, or multiple therapies. The patients were followed for 2 years after the index diagnosis date to assess their treatment patterns and outcomes. A total of 144,098 patients met the study criteria. Of these patients, 100,072 (69.5%) were under surveillance for disease progression and/or received compression therapy; 14,007 (9.7%) received laser ablation; 9125 (6.3%) received radiofrequency ablation; 4778 (3.3%) received sclerotherapy; 4851 (3.4%) had surgery; and 11,265 (7.8%) received multiple therapies. During the 2-year follow-up period, among patients receiving interventional treatment, 54.7% of patients received additional interventional treatment (either with the same mode or a different mode from the initial treatment); 30.1% had >1 postintervention claim for symptomatic

  2. Treatment Patterns and Outcomes in Patients with Varicose Veins

    PubMed Central

    Mallick, Rajiv; Raju, Aditya; Campbell, Chelsey; Carlton, Rashad; Wright, David; Boswell, Kimberly; Eaddy, Michael

    2016-01-01

    Background Approximately 24% of adults in the United States have visible varicose veins, and an estimated 6% have evidence of advanced chronic venous disease. The majority of individuals with varicose veins seek treatment because of symptoms, such as aching, throbbing, fatigue, pruritus, ankle swelling, and tenderness, rather than cosmetic reasons. Furthermore, varicose veins are a manifestation of chronic venous insufficiency, which can progress to leg pain, leg edema, chronic skin changes, and nonhealing ulcers. Objective To assess varicose vein treatment patterns and their corresponding outcomes, including additional treatment rates, disease progression to new ulcers, and associated costs from a US perspective. Methods We conducted a retrospective claims database study using data from the Truven Health MarketScan database. Adults who were newly diagnosed with varicose veins between January 1, 2008, and June 30, 2010, and met the study inclusion criteria were eligible to participate and were divided into 6 cohorts based on the type of first or initial therapy they received after the index diagnosis date, including surveillance and compression therapy, surgery, laser ablation, radiofrequency ablation, sclerotherapy, or multiple therapies. The patients were followed for 2 years after the index diagnosis date to assess their treatment patterns and outcomes. Results A total of 144,098 patients met the study criteria. Of these patients, 100,072 (69.5%) were under surveillance for disease progression and/or received compression therapy; 14,007 (9.7%) received laser ablation; 9125 (6.3%) received radiofrequency ablation; 4778 (3.3%) received sclerotherapy; 4851 (3.4%) had surgery; and 11,265 (7.8%) received multiple therapies. During the 2-year follow-up period, among patients receiving interventional treatment, 54.7% of patients received additional interventional treatment (either with the same mode or a different mode from the initial treatment); 30.1% had >1

  3. Outcome evaluation of the opioid agonist maintenance treatment in Iran.

    PubMed

    Esmaeili, Hamid-Reza; Ziaddinni, Hassan; Nikravesh, Mohammad-Rafee; Baneshi, Mohammad-Reza; Nakhaee, Nouzar

    2014-03-01

    Methadone maintenance treatment and buprenorphine maintenance treatment are the two main therapeutic options considered for opioid replacement therapy. This study was conducted to examine the effectiveness of methadone maintenance treatment and buprenorphine maintenance treatment in Iran under usual clinical conditions. In this outcome research, 311 patients consented to participate in the study (77.8% response rate). The Opioid Treatment Index, General Health Questionnaire and WHOQOL-BREF questionnaire were used to assess the effectiveness of the therapeutic programs. Drop-out rate was calculated after two and six months of treatment. Mean dose of methadone was in an acceptable range; however, doses for buprenorphine maintenance treatment patients seemed low. The rates of attrition after two and six months of treatment were 24.2% and 44.0% in the methadone maintenance treatment group and 41.3% and 65.4% in the buprenorphine maintenance treatment group, respectively (P < 0.001). Drug use, HIV risk-taking behaviour, and mental and physical health improved in both groups at six months of treatment, while quality of life improved only in the methadone maintenance treatment group. The retention seen in the buprenorphine group may in part be related to the low buprenorphine doses used. As a whole, the positive results provide support to continuation of maintenance programs. © 2014 Australasian Professional Society on Alcohol and other Drugs.

  4. Hispanic Subgroups, Acculturation, and Substance Abuse Treatment Outcomes.

    PubMed

    Chartier, Karen G; Carmody, Tom; Akhtar, Maleeha; Stebbins, Mary B; Walters, Scott T; Warden, Diane

    2015-12-01

    This study explored Hispanic subgroup differences in substance use treatment outcomes, and the relationship of acculturation characteristics to these outcomes. Data were from a multisite randomized clinical trial of motivational enhancement therapy versus treatment as usual in a sample of Spanish-speaking substance abusers. Participants were Cuban American (n=34), Mexican American (n=209), Puerto Rican (n=78), and other Hispanic American (n=54). Results suggested that Cuban Americans and individuals with more connection to Hispanic culture had lower treatment retention. Hispanics born in the U.S and those who spoke English at home had a lower percentage of days abstinent during weeks 5-16, although Puerto Ricans born in the U.S. and Cuban Americans living more years in the U.S. had a higher percentage of days abstinent in weeks 1-4 and 5-16, respectively. Results may inform future hypothesis-driven studies in larger Hispanic treatment seeking samples of the relationship between acculturation and treatment outcome. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. Psychosocial stress and treatment outcome following assisted reproductive technology.

    PubMed

    Sanders, K A; Bruce, N W

    1999-06-01

    This study investigated the association between psychosocial stress and outcome of in-vitro fertilization and gamete intra-Fallopian transfer treatment. Ninety women, enrolled for treatment at a private infertility clinic, completed two self-administered psychometric tests (Bi-polar Profile of Mood States, POMS; and State-Trait Anxiety Inventory, STAI) and a questionnaire to ascertain demographic and lifestyle characteristics before the start of treatment. Approximately 12 months later an outcome measure was determined for each participant in terms of whether she was pregnant or not pregnant and the number of treatment cycles undertaken to achieve clinical pregnancy. The women's scores on the psychological tests were similar to published normative scores. On univariate analysis, history of a previous pregnancy was positively related to the probability of pregnancy and full-time employment, a more 'hostile' mood state and higher trait anxiety were associated with a lower cumulative pregnancy rate. A Cox multiple regression model found previous pregnancy history, trait anxiety, and the POMS agreeable-hostile and elated-depressed scales to be the most important lifestyle and stress variables predictive of pregnancy. The results emphasize the importance of psychosocial stress in treatment outcome but indicate that the relationships are complex. Further studies are required to validate whether these findings can be generalized to other populations.

  6. Hispanic Subgroups, Acculturation, and Substance Abuse Treatment Outcomes

    PubMed Central

    Chartier, Karen G.; Carmody, Tom; Akhtar, Maleeha; Stebbins, Mary B.; Walters, Scott T.; Warden, Diane

    2015-01-01

    This study explored Hispanic subgroup differences in substance use treatment outcomes, and the relationship of acculturation characteristics to these outcomes. Data were from a multisite randomized clinical trial of motivational enhancement therapy versus treatment as usual in a sample of Spanish-speaking substance abusers. Participants were Cuban American (n=34), Mexican American (n=209), Puerto Rican (n=78), and other Hispanic American (n=54). Results suggested that Cuban Americans and individuals with more connection to Hispanic culture had lower treatment retention. Hispanics born in the U.S and those who spoke English at home had a lower percentage of days abstinent during weeks 5-16, although Puerto Ricans born in the U.S. and Cuban Americans living more years in the U.S. had a higher percentage of days abstinent in weeks 1-4 and 5-16, respectively. Results may inform future hypothesis-driven studies in larger Hispanic treatment seeking samples of the relationship between acculturation and treatment outcome. PMID:26362001

  7. Alendronate reduces the daily consumption of insulin (DCI) in patients with senile type I diabetes and osteoporosis.

    PubMed

    Maugeri, D; Panebianco, P; Rosso, D; Calanna, A; Speciale, S; Santangelo, A; Rizza, I; Motta, M; Lentini, A; Malaguarnera, M

    2002-01-01

    The use of Alendronate for the treatment of senile diabetes with osteopenia or osteoporosis is a common practice today, although the reasons for the success of this treatment are not completely understood. We investigated 40 elderly female patients, over 70 years of age, divided in two Groups (A and B) 20 cases of each, with insulin-dependent senile diabetes and fair metabolic balance, with an average disease duration of 30 +/- 4 years. They all had osteoporosis shown by the mean T-score of bone mineral densitometry. The Groups were treated as follows, Group A with 10 mg/day of Alendronate per os, with morning fasting plus a supplementation of calcium and vitamin D3, while the Group B received only calcium and vitamin D3 per os. Bone mineral density (BMD) expressed in mg/cm2, and in terms of T-score and Z-score at the spine (L1-L4) was monitored over time after 12 and 24 months, using dexa technique with a Lunar DPX densitometer. Moreover, the variation of daily consumption of insulin (DCI) of all the study population was calculated 12 and 24 months after the start of treatments. The data of Group A showed an improvement of osteoporosis, as evidenced by the increase of BMD at both times of measurement, accompanied by a significant reduction in the DCI (-21.6% by the 12th month, and -36.2% by the end of the observation period). In the Group B only small, statistically insignificant changes were observed in both the BMD and DCI. The most plausible explanation of reduction of DCI in Group A seems to be that Alendronate has improved the clinical symptoms of osteoporosis (pain, rigidity, and reduction of movements) through its action on the bone mass recovery and slowing down the bone turnover and under these conditions the diabetic patients improved their own physical performance. The better and more extensive movements certainly produced a reduction in the DCI, since a correct and adequate physical activity does contribute to an improved glucose metabolism.

  8. Metformin and improved treatment outcomes in radiation therapy - A review.

    PubMed

    Samsuri, Nur Atiqah Binte; Leech, Michelle; Marignol, Laure

    2017-04-01

    Metformin, a primary treatment for diabetes mellitus (DM) patients, is associated with improved outcomes for diabetic cancer patients fuelling further investigation on its mechanisms of action. The radiosensitising properties of metformin are increasingly reported in pre-clinical studies. This review discusses whether metformin should be offered to radiotherapy (RT) cancer patients as a means to improve their treatment outcomes. A database search was conducted for articles published with metformin as the main intervention between 2010 and 2016. Three groups of RT cancer patients were analysed: diabetic patients using metformin, diabetic patients not using metformin and non-diabetic patients not using metformin. Data on survival and recurrence metrics were extracted. Thirteen studies were included. Conflicting evidence exists with regards to the impact of metformin administration on recurrence and survival outcomes following radiotherapy. Three studies reported improved tumour response determined by recurrence rates while five studies did not observe differences or metformin use was not the associated reason. One study revealed inconsistent tumour response results. Metformin was reported as improving survival outcomes in 2 studies and not improving outcomes in 5 studies. 4 studies showed indefinite results. Although metformin may improve tumour response in the non-randomized, retrospective studies analysed, it may not necessarily confer survival benefits. Future prospective and randomised trials are required to translate the positive impact of metformin documented in pre-clinical and retrospective studies into improve management of RT cancer patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. Tooth positioners and their effects on treatment outcome

    PubMed Central

    Pravindevaprasad, A.; Therese, Beena Agnes

    2013-01-01

    Malocclusion can also be corrected by means of clear removable appliances called as “tooth positioners” or “aligners”. A tooth positioner is used to control settling and to minimize or eliminate relapse of the teeth after an orthodontic treatment. In this article, a complete review of the objectives, course of treatment, fabrication, and the materials used for fabrication of tooth positioners along with their importance and disadvantages were discussed. Tooth positioners did improve the overall orthodontic treatment outcome as quantified by the ABO (American Board of orthodontics) objective scoring method. But once the initial occlusal contact was achieved, the vertical movement of teeth was found to be inhibited. PMID:24082720

  10. Registering initial defaulters and reporting on their treatment outcomes.

    PubMed

    Harries, A D; Rusen, I D; Chiang, C-Y; Hinderaker, S G; Enarson, D A

    2009-07-01

    This Unresolved Issues article highlights three original articles that appeared last year in the Journal discussing the phenomenon of initial defaulters. There are three important challenges with patients that appear in the laboratory sputum register but are not recorded in the tuberculosis (TB) patient register: the first is how to identify these patients, trace them and get them on to treatment as soon as possible; the second is how to register and report on these cases as part of the case-finding component of TB control; and the third is whether to include these initial default patients in the cohort analysis of treatment outcomes. We recommend a step-wise approach to these challenges and advocate that these patients be included, wherever possible, in the TB patient register and in the cohort analysis of treatment outcomes.

  11. Stereoacuity Outcomes Following Treatment of Infantile and Accommodative Esotropia

    PubMed Central

    Birch, Eileen E.; Wang, Jingyun

    2009-01-01

    Purpose To review what is known about the normal maturation of stereoacuity, the stereoacuity deficits associated with infantile and accommodative esotropia, the rationale for making improved stereoacuity a goal of treatment, and strategies for improving stereoacuity outcomes. Methods Studies of stereoacuity maturation during normal development, studies of stereoacuity outcomes following treatment for infantile and accommodative esotropia, and studies of primate models of esotropia are reviewed. Results Stereoacuity maturation normally proceeds rapidly during the first year of life. Infantile and accommodative esotropia are associated with profound and permanent disruption of stereopsis. While rehabilitation of stereoacuity following treatment of esotropia remains a challenge, even the achievement of subnormal stereoacuity may have real benefits to the child. Conclusions Some abnormalities in stereoacuity may exist before the onset of esotropia, but others may result directly from abnormal binocular experience. Several strategies for improving stereoacuity outcomes in esotropia are currently under active investigation. Improved stereoacuity outcomes are associated with better long term stability of alignment, reduced risk for and/or severity of amblyopia, improved achievement of sensorimotor developmental milestones, better reading ability, and improved long-term quality of life. PMID:19390468

  12. Predictors of outcome in residential cognitive and interpersonal treatment for social phobia: do cognitive and social dysfunction moderate treatment outcome?

    PubMed

    Borge, Finn-Magnus; Hoffart, Asle; Sexton, Harold

    2010-09-01

    The predictors of residential cognitive (RCT) and residential interpersonal Treatment (RIPT) for social phobia were explored. (1) Sotsky et al. (1991) found differential effects of CT and IPT for depression, suggesting that the level of cognitive or social dysfunction predicted differential outcome. We examined whether an analogous effect could be demonstrated in 10 weeks of residential treatment of 80 social phobia subjects. (2) We also included expectations, age of onset, severity of illness, concurrent anxiety, mood, avoidant personality disorder, and body dysmorphic disorder as predictors in this exploratory study. Main outcome was the social phobia subscale of Social Phobia and Anxiety Inventory (SPAI SP). DSM-IV axis I and II interviews were completed. (1) Sotsky et al. (1991) findings were not reproduced. However, RIPT subjects with poor general functioning were less improved following treatment. Subjects with concurrent agoraphobia responded better with RCT than subjects without agoraphobia. (2) Age of onset and expectations were the most powerful predictors of post treatment outcome. Some patient characteristics appear to impact outcome with RIPT and RCT differentially. The findings are discussed. (c) 2010 Elsevier Ltd. All rights reserved.

  13. Delay Discounting Predicts Adolescent Substance Abuse Treatment Outcome

    PubMed Central

    Stanger, Catherine; Ryan, Stacy R.; Fu, Hongyun; Landes, Reid D.; Jones, Bryan A.; Bickel, Warren K.; Budney, Alan J.

    2014-01-01

    The purpose of the current study was to identify predictors of delay discounting among adolescents receiving treatment for marijuana abuse or dependence, and to test delay discounting as a predictor of treatment outcome. Participants for this study were 165 adolescents (88% male) between the ages of 12 and 18 (M =15.8; SD = 1.3) who enrolled in a clinical trial comparing three behavioral treatments for adolescent marijuana abuse or dependence. Participants completed a delay discounting task at treatment onset for $100 and $1,000 of hypothetical money and marijuana. Overall, smaller magnitude rewards were discounted more than larger magnitude rewards. Delay discounting rates were concurrently related to demographic variables (SES, race). Delay discounting of $1,000 of money predicted during treatment abstinence outcomes among adolescent marijuana abusers, over and above the effects of type of treatment received. Teens who show higher levels of discounting of the future may be an important subgroup to identify at treatment onset. Youth with a greater tendency to discount the future may require different intervention strategies that address their impulsivity (e.g., targeting executive function or inhibitory control) and/or different schedules of reinforcement to address their degree of preference for immediate rewards. PMID:22182419

  14. Marijuana use and treatment outcome among opioid-dependent patients.

    PubMed

    Budney, A J; Bickel, W K; Amass, L

    1998-04-01

    Information concerning the association between marijuana use and opioid dependence and its treatment is needed to determine effective clinical guidelines for addressing marijuana use among opioid abusers. Marijuana use was assessed in 107 people enrolled in treatment for opioid dependence. Univariate comparisons of marijuana users and non-users and multivariate regression analyses were performed to examine associations between marijuana use and socio-demographic, psychosocial, medical and substance-use variables. The relationship between marijuana use and treatment outcome was also explored in a subset of this sample who received treatment that included buprenorphine detoxification and behavior therapy (N = 79). Sixty-six per cent of participants were current marijuana users and almost all (94%) continued to use during treatment. Users were less likely to be married than non-users, and more likely to report financial difficulties, be involved in drug dealing and engage in sharing of needles (p < 0.05). A unique effect of marijuana use on drug dealing and sharing needles was retained after statistically controlling for the influence of heroin and alcohol use and other socio-demographic variables. No significant adverse relations were observed between marijuana use and treatment outcome. Pending a more comprehensive understanding of the function and consequences of marijuana use on psychosocial functioning, it appears that progress in treatment for opioid dependence can be made without mandating that patients abstain from marijuana use.

  15. Barriers to Implementing Treatment Integrity Procedures in School Psychology Research: Survey of Treatment Outcome Researchers

    ERIC Educational Resources Information Center

    Sanetti, Lisa M. Hagermoser; DiGennaro Reed, Florence D.

    2012-01-01

    Treatment integrity data are essential to drawing valid conclusions in treatment outcome studies. Such data, however, are not always included in peer-reviewed research articles in school psychology or related fields. To gain a better understanding of why treatment integrity data are lacking in the school psychology research, we surveyed the…

  16. Barriers to Implementing Treatment Integrity Procedures in School Psychology Research: Survey of Treatment Outcome Researchers

    ERIC Educational Resources Information Center

    Sanetti, Lisa M. Hagermoser; DiGennaro Reed, Florence D.

    2012-01-01

    Treatment integrity data are essential to drawing valid conclusions in treatment outcome studies. Such data, however, are not always included in peer-reviewed research articles in school psychology or related fields. To gain a better understanding of why treatment integrity data are lacking in the school psychology research, we surveyed the…

  17. Comparing Outcomes for Youth Served in Treatment Foster Care and Treatment Group Care

    ERIC Educational Resources Information Center

    Robst, John; Armstrong, Mary; Dollard, Norin

    2011-01-01

    This study compared youth in the Florida Medicaid system prior to entry into treatment foster care or treatment group care, and compared outcomes in the 6 months after treatment. Florida Medicaid data from FY2003/04 through 2006/2007 along with Department of Juvenile Justice, Department of Law Enforcement, and involuntary examination data were…

  18. Comparing Outcomes for Youth Served in Treatment Foster Care and Treatment Group Care

    ERIC Educational Resources Information Center

    Robst, John; Armstrong, Mary; Dollard, Norin

    2011-01-01

    This study compared youth in the Florida Medicaid system prior to entry into treatment foster care or treatment group care, and compared outcomes in the 6 months after treatment. Florida Medicaid data from FY2003/04 through 2006/2007 along with Department of Juvenile Justice, Department of Law Enforcement, and involuntary examination data were…

  19. Effect of alendronate on periodontal disease in postmenopausal women: a randomized placebo-controlled trial.

    PubMed

    Rocha, Miriam L; Malacara, Juan M; Sánchez-Marin, Francisco J; Vazquez de la Torre, Carlos J; Fajardo, Martha E

    2004-12-01

    We investigated the effect of oral alendronate (ALN) treatment on radiological and clinical measurements of periodontal disease in postmenopausal women without hormone replacement therapy. We evaluated the effect of 6 months of ALN treatment in 40 postmenopausal women, 55 to 65 years old with established periodontal disease, in a controlled, double-masked, prospective study. Volunteers were paired by age and randomized to receive ALN (10 mg/day) or placebo for the study period. Periodontal mechanical treatment was carried out in both groups. At baseline and after treatment, clinical evaluation, hormone blood levels, distance from the crestal alveolar bone (CAB) to the cemento-enamel junction (CEJ), calcaneus bone mineral density (BMD), hormone levels, serum N-telopeptide (NTx), and bone-specific alkaline phosphatase (BSAP) were assessed. Periodontal disease conditions improved in both groups, but greater improvement in probing depth (-0.8 +/- 0.3 mm versus -0.4 +/- 0.4 mm, P = 0.02) and gingival bleeding (-0.3% +/- 0.13% versus -0.2% +/- 0.06%, P = 0.006) was found in the ALN treated group. Calcaneus BMD increased in the ALN treated group (68 +/- 47 mm3 versus -26 +/- 81 mm3, P = 0.0006). CAB-CEJ distance diminished in the ALN group (-0.4 +/- 0.40 mm versus 0.60 +/- 0.53 mm, P = 0.00008). Marginal reduction in both NTx and BSAP levels was found in the ALN group (-9.4 +/- 6.6 nmol versus -4.3 +/- 4.7 nmol bone collagen equivalents, P = 0.08, and -7.7 +/- 8.4 versus -1.5 +/- 5.0 U/l, P = 0.1, respectively). Hormone levels were unchanged after treatment. Similar improvement of calcaneus BMD and CAB-CEJ distance with ALN treatment was found in obese and non-obese women. ALN treatment improved periodontal disease and bone turnover in postmenopausal women.

  20. Alendronate increases bone mass and reduces bone markers in postmenopausal African-American women.

    PubMed

    Bell, Norman H; Bilezikian, John P; Bone, Henry G; Kaur, Amarjot; Maragoto, Adele; Santora, Arthur C

    2002-06-01

    Previous studies indicated that aminobisphosphonate alendronate sodium, a potent inhibitor of bone resorption, increases bone mineral density (BMD) at the hip and spine, reduces markers of bone turnover, and reduces the risk of fractures in Caucasian postmenopausal women. The purpose of the present study was to investigate whether alendronate increases BMD and reduces markers of bone turnover in African-American postmenopausal women. In a multicenter, randomized, double-blind, placebo-controlled study, 65 African-American women, aged 45 to 88 yr, were randomly assigned to either placebo (n = 33) or alendronate 10 mg daily (n = 32) for 2 yr. Mean BMD T scores of the lumbar spine at baseline were -3.18 in the placebo-treated group and -3.09 in the alendronate-treated group. All women took 500 mg elemental calcium daily in the form of calcium carbonate and 500 IU vitamin D. Alendronate significantly increased BMD and reduced markers of bone formation and resorption, compared with placebo. At 2 yr, mean changes +/- SE in BMD were 6.5% +/- 0.7% for the lumbar spine (P < 0.001), 4.5% +/- 1.0% for the femoral neck (P < 0.001), 6.4% +/- 0.6% for the femoral trochanter (P < 0.001), 4.1% +/- 0.7% for the total hip (P < 0.001), 0.7% +/- 0.5% for the one third forearm (NS), and 2.0% +/- 0.4% for the total body (P < 0.001) in women treated with alendronate, compared with 0.9% +/- 0.6% (NS), 0.5% +/- 1.1% (NS), -0.2 +/- 0.8 (NS), -1.1 +/- 0.7% (NS), -0.8% +/- 0.6% (NS), and -1.2% +/- 0.6% (P < 0.05) for the lumbar spine, femoral neck, trochanter, total hip, one third forearm, and total body, respectively, in women treated with placebo. At 2 yr, mean serum bone-specific alkaline phosphatase had declined by 46.3% with alendronate (P < 0.001) and 13.6% with placebo (P < 0.01), and mean urinary N-telopeptide of type I collagen/creatinine ratio had declined by 70.5% with alendronate (P < 0.001) and 6.7% with placebo (NS). The incidence of adverse experiences was not different between

  1. Smoking Status and Substance Use Treatment Outcomes Among Spanish Speakers Enrolled in Substance Abuse Treatment.

    PubMed

    de Dios, Marcel A; Cano, Miguel Ángel; Childress, Sarah; Vaughan, Ellen; Cerna, Yohanna; Niaura, Raymond

    2016-10-01

    Smoking is highly prevalent among individuals with drug and alcohol disorders. Concurrent tobacco dependence treatment during substance use disorder (SUD) treatment is supported, yet the association between SUD treatment outcomes and smoking status has been understudied in minorities, including Latinos. Participants were 322 Spanish-speaking Latinos enrolled in a SUD treatment study in 5 U.S. cities. Logistic regression examined associations between baseline smoking status and treatment outcomes for nontobacco substance use at follow-up. Covariates included age, gender, level of education, marital status, treatment group, and mandated treatment status. Results indicated smokers had a reduced likelihood of abstinence for all nontobacco substances (p = .001) and their primary drug of use (p = .007). Findings contribute to the growing literature indicating a possible beneficial effect of smoking cessation services on SUD treatment, specifically among Latinos. Further research is needed to identify ideal smoking cessation treatments for Latinos. © 2016 Wiley Periodicals, Inc.

  2. Treatment compliance and outcome in obsessive-compulsive disorder.

    PubMed

    Abramowitz, Jonathan S; Franklin, Martin E; Zoellner, Lori A; DiBernardo, Corrie L

    2002-09-01

    Exposure and ritual prevention (EX/RP) is an effective treatment for obsessive compulsive-disorder (OCD), although it is neither universally nor completely helpful. Compliance with EX/RP treatment procedures has been linked theoretically to posttreatment outcome, yet empirical exploration of this relationship has been insufficient. In this study, therapists were asked to rate the treatment compliance of 28 consecutive patients who received EX/RP on a fee-for-service basis. Results indicated that understanding the treatment rationale and compliance with in-session and homework exposure instructions, but not with ritual prevention and self-monitoring of rituals, was significantly related to posttreatment OCD symptom severity. Clinical implications of these findings and future directions in treatment compliance research with OCD patients are discussed.

  3. Hospital–Physician Affiliations and Patient Treatments, Expenditures, and Outcomes

    PubMed Central

    Madison, Kristin

    2004-01-01

    Objective To determine the relationship between hospital–physician affiliations and the treatments, expenditures, and outcomes of patients. Data Sources Sources include the Medicare Provider Analysis and Review dataset, the American Hospital Association (AHA) Annual Survey, and the Area Resource File (ARF). Study Design A multivariate regression analysis of the relationship between hospital–physician affiliations (such as physician–hospital organizations [PHOs] or salaried employment) and the treatment of Medicare patients with a diagnosis of acute myocardial infarction admitted to general medical-surgical hospitals between 1994 and 1998. Dependent variables include whether the patient received a catheterization or angioplasty or bypass surgery; whether a patient was readmitted, or died within 90 days of initial admission; and expenditures. Independent variables include patient, admission hospital, and market characteristics, as well as hospital and year fixed effects. Principal Findings The integrated salary model form of hospital–physician affiliation is associated with slightly higher procedure rates, and higher patient expenditures. At the same time, there is little evidence that hospital–physician affiliations in the aggregate have had any measurable impact on patient treatment or outcomes. Conclusions The limited effect of hospital–physician affiliations on patient outcomes is consistent with previous research showing that affiliations have not much changed the nature of health care delivery. However, the finding that the integrated salary model is associated with higher treatment intensity suggests that affiliations may have had some impact on patients, and could have more in the future. PMID:15032954

  4. Family treatment of child anxiety: outcomes, limitations and future directions.

    PubMed

    Creswell, Cathy; Cartwright-Hatton, Sam

    2007-09-01

    Anxiety of childhood is a common and serious condition. The past decade has seen an increase in treatment-focussed research, with recent trials tending to give greater attention to parents in the treatment process. This review examines the efficacy of family-based cognitive behaviour therapy and attempts to delineate some of the factors that might have an impact on its efficacy. The choice and timing of outcome measure, age and gender of the child, level of parental anxiety, severity and type of child anxiety and treatment format and content are scrutinised. The main conclusions are necessarily tentative, but it seems likely that Family Cognitive Behaviour Therapy (FCBT) is superior to no treatment, and, for some outcome measures, also superior to Child Cognitive Behaviour Therapy (CCBT). Where FCBT is successful, the results are consistently maintained at follow-up. It appears that where a parent is anxious, and this is not addressed, outcomes are less good. However, for children of anxious parents, FCBT is probably more effective than CCBT. What is most clear is that large, well-designed studies, examining these factors alone and in combination, are now needed.

  5. Speech outcomes of a prolonged-speech treatment for stuttering.

    PubMed

    Onslow, M; Costa, L; Andrews, C; Harrison, E; Packman, A

    1996-08-01

    It has been shown that people who stutter can speak with greatly reduced stuttering after treatments that use variations of Goldiamond's (1965) prolonged-speech (PS). However, outcome research to date has not taken account of several important issues. In particular, speech outcome measures in that research have been insufficient to show that lasting relief from stuttering has been achieved by clients outside the clinic for meaningful periods. The present study used extensive speech outcome measures across a variety of situations in evaluating the outcome of an intensive PS treatment (Ingham, 1987). The speech of 12 clients in this treatment was assessed on three occasions prior to treatment and frequently-on eight occasions-after discharge from the residential setting. For 7 clients, a further assessment occurred at 3 years posttreatment. Concurrent dependent measures were percent syllables stuttered, syllables per minute, and speech naturalness. The dependent measures were collected in many speaking situations within and beyond the clinic. Dependent measures were based on speech samples of substantive duration, and covert assessments were included in the study. Detailed data were presented for individual subjects. Results showed that 12 subjects who remained with the entire 2-3-year program achieved zero or near-zero stuttering. The majority of subjects did not show a regression trend in %SS or speech naturalness scores during the posttreatment period, either within or beyond the clinic. Some subjects showed higher posttreatment %SS scores during covert assessment than during overt assessment. Results also showed that stuttering was eliminated without using unusually slow and unnatural speech patterns. This treatment program does not specify a target speech rate range, and many clients maintained stutter-free speech using speech rates that were higher than the range typically specified in intensive PS programs. A significant correlation was found between speech

  6. Apically Extruded Sealers: Fate and Influence on Treatment Outcome.

    PubMed

    Ricucci, Domenico; Rôças, Isabela N; Alves, Flávio R F; Loghin, Simona; Siqueira, José F

    2016-02-01

    This retrospective study evaluated cases of unintentional overfillings for the fate of the extruded sealers and their influence on treatment outcome. One hundred five teeth treated by a single operator and exhibiting overfillings in the postobturation radiograph were included in the study. Seventy-five teeth exhibited apical periodontitis lesions at the time of treatment. Sealers included Pulp Canal Sealer (Sybron Dental, Orange, CA), PCS Extended Working Time-EWT (Sybron Dental), Tubli-Seal (Sybron Endo), Endomethasone (Septodont, Saint-Maur-des-Fossés, France), AH Plus (DeTrey GmbH, Konstanz, Germany), and Apexit (Ivoclar Vivadent, Schaan, Lichtenstein). Recall radiographs were compared with immediate postobturation films for removal of the extruded material and status of the periradicular tissues. Data were grouped as 1-, 2- and >4-year recall and statistically analyzed using the chi-square and Fisher exact tests. As for the sealers' fate, the only statistically significant differences at the 1-year recall were observed when comparing Tubli-Seal with AH Plus, Apexit, and Endomethasone (P < .05). At both the 2- and 4-year recalls, frequency of complete removal of AH Plus and Apexit was significantly lower when compared with all the other sealers (P < .05). No other significant differences were observed between groups. As for the influence on treatment outcome, there were no statistically significant differences between sealers at all follow-up periods (P > .05). Data from the >4-year recall revealed that 79% of the teeth with apical periodontitis lesions at the time of treatment had healed in comparison with 100% of the teeth with no apical periodontitis (P < .01). Not all extruded sealers were predictably removed from the periradicular tissues. Treatment outcome was not significantly affected by the type of extruded sealer. A significantly better outcome was observed for teeth with no lesion in comparison with teeth with apical periodontitis. Copyright © 2016

  7. In vitro disintegration studies of weekly generic alendronate sodium tablets (70 mg) available in the US.

    PubMed

    Dansereau, Richard J; Crail, Debbie J; Perkins, Alan C

    2009-02-01

    Bisphosphonates as a class have the potential to cause upper gastrointestinal irritation. Although the generic alendronate sodium tablets are bioequivalent to the branded product, a potential concern is that the pharmaceutical attributes of the various generic formulations my affect the potential for local irritation and tolerability. The in vitro disintegration times were determined using the method described in the US Pharmacopeia 30 (USP 30). The disintegration of three generic alendronate sodium tablets 70 mg available in the United States was compared to that of the branded product. The mean disintegration times of the generic alendronate sodium tablets ranged from 9 to 10 s for the Barr lots to 108 s for the Watson lot. The disintegration time of the branded product (Fosamax) was 53 s. The three Barr lots and one Teva lot had rapid disintegration times which were similar to the disintegration standards (< 30 s) for orally disintegrating tablets. Since there is no established disintegration time for alendronate sodium tablets there can be no assurance that the generic tablets are equivalent to the branded product in terms of esophageal exposure. However, the in vitro disintegration times have not been correlated with in vivo disintegration performance. Copies of generic alendronate sodium tablets are approved based on the results of single-dose bioavailability studies in healthy subjects and this is not considered adequate to establish similar disintegration characteristics.

  8. Biodistribution and Pharmacokinetic Studies of Bone-Targeting N-(2-Hydroxypropyl)methacrylamide Copolymer–Alendronate Conjugates

    PubMed Central

    Pan, Huaizhong; Sima, Monika; Kopečková, Pavla; Wu, Kuangshi; Gao, Songqi; Liu, Jihua; Wang, Dong; Miller, Scott C.; Kopeček, Jindřich

    2015-01-01

    The biodistribution and pharmacokinetics of bone-targeting N-(2-hydroxypropyl)-methacrylamide (HPMA) copolymer–alendronate conjugates were evaluated following intravenous administration of radioiodinated conjugates to young healthy BALB/c mice. The synthesis of a polymerizable and cathepsin K cleavable alendronate derivative, N-methacryloylglycylglycylprolylnorleucylalendronate, enabled the preparation of HPMA copolymer–alendronate conjugates with varying composition. Using the RAFT (reversible addition–fragmentation chain transfer) polymerization technique, four conjugates with different molecular weight and alendronate content and two control HPMA copolymers (without alendronate) with different molecular weight were prepared. The results of biodistribution studies in mice demonstrated a strong binding capacity of alendronate-targeted HPMA copolymer conjugates to bone. Conjugates with low (1.5 mol%) alendronate content exhibited a similar bone deposition capacity as conjugates containing 8.5 mol % of alendronate. The molecular weight was an important factor in the biodistribution of the HPMA copolymer conjugates. More conjugate structures need to be evaluated, but the data suggest that medium molecular weights (50–100 kDa) might be effective drug carriers for bone delivery. PMID:18505266

  9. Biodistribution and pharmacokinetic studies of bone-targeting N-(2-hydroxypropyl)methacrylamide copolymer-alendronate conjugates.

    PubMed

    Pan, Huaizhong; Sima, Monika; Kopecková, Pavla; Wu, Kuangshi; Gao, Songqi; Liu, Jihua; Wang, Dong; Miller, Scott C; Kopecek, Jindrich

    2008-01-01

    The biodistribution and pharmacokinetics of bone-targeting N-(2-hydroxypropyl)methacrylamide (HPMA) copolymer-alendronate conjugates were evaluated following intravenous administration of radioiodinated conjugates to young healthy BALB/c mice. The synthesis of a polymerizable and cathepsin K cleavable alendronate derivative, N-methacryloylglycylglycylprolylnorleucylalendronate, enabled the preparation of HPMA copolymer-alendronate conjugates with varying composition. Using the RAFT (reversible addition-fragmentation chain transfer) polymerization technique, four conjugates with different molecular weight and alendronate content and two control HPMA copolymers (without alendronate) with different molecular weight were prepared. The results of biodistribution studies in mice demonstrated a strong binding capacity of alendronate-targeted HPMA copolymer conjugates to bone. Conjugates with low (1.5 mol%) alendronate content exhibited a similar bone deposition capacity as conjugates containing 8.5 mol % of alendronate. The molecular weight was an important factor in the biodistribution of the HPMA copolymer conjugates. More conjugate structures need to be evaluated, but the data suggest that medium molecular weights (50-100 kDa) might be effective drug carriers for bone delivery.

  10. Contralateral Vocal Fold Reactive Lesions: Nomenclature, Treatment Choice, and Outcome.

    PubMed

    Koss, Shira L; Kidwai, Sarah M; Pitman, Michael J

    2016-06-01

    Contralateral reactive lesions (RLs) represent a distinct entity among benign bilateral vocal fold (VF) lesions. Lack of uniform nomenclature and a myriad of surgical options have hampered attempts to develop treatment guidelines. The objective of this study is to better define RLs and their prognosis, through the development of a standard nomenclature, with an aim to guide treatment and delineate the role of phonosurgery. Case series with chart review. Tertiary care center. Analysis was performed on patients with Current Procedural Terminology code 31545. Operative reports with a primary lesion and contralateral RL were included. Outcomes included the Voice Handicap Index-10 (VHI-10) and GRBAS (grade, roughness, breathiness, asthenia, and strain) scale, lesion persistence/recurrence, mucosal wave, and edge character based on blinded videostroboscopy review. A nomenclature was developed based on intraoperative RLs (n = 30), defined by lesion consistency (fibrous or polypoid) and relationship to normal VF edge (gradual or steep). Reactive lesion treatment included no intervention, excision, potassium titanyl phosphate laser, steroid injection, or a combination thereof. Observations included the following: inconsistent treatment modalities were employed, excision of RLs did not yield better outcomes, fibrous RLs were more likely to persist and polypoid lesions more likely to recur, gradual lesions were more likely to remain disease free, and most treatments showed improved mucosal wave, VHI-10, and GRBAS. Reactive lesions have not been well classified, and treatments are based on subjective intraoperative decision making with unpredictable outcomes. The nomenclature proposed will allow for a better definition of the RL and provide a framework for future research to identify optimal treatment. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.

  11. ADHD, Multimodal Treatment, and Longitudinal Outcome: Evidence, Paradox, and Challenge

    PubMed Central

    Arnold, L. Eugene

    2014-01-01

    Given major increases in the diagnosis of attention-deficit hyperactivity disorder (ADHD) and in rates of medication for this condition, we carefully examine evidence for effects of single versus multimodal (i.e., combined medication and psychosocial/behavioral) interventions for ADHD. Our primary data source is the Multimodal Treatment Study of Children with ADHD (MTA), a 14-month, randomized clinical trial in which intensive behavioral, medication, and multimodal treatment arms were contrasted with one another and with community intervention (treatment-as-usual), regarding outcome domains of ADHD symptoms, comorbidities, and core functional impairments. Although initial reports emphasized the superiority of well-monitored medication for symptomatic improvement, reanalyses and reappraisals have highlighted (a) the superiority of combination treatment for composite outcomes and for domains of functional impairment (e.g., academic achievement, social skills, parenting practices); (b) the importance of considering moderator and mediator processes underlying differential patterns of outcome, including comorbid subgroups and improvements in family discipline style during the intervention period; (c) the emergence of side effects (e.g., mild growth suppression) in youth treated with long-term medication; and (d) the diminution of medication’s initial superiority once the randomly assigned treatment phase turned into naturalistic follow-up. The key paradox is that whereas ADHD clearly responds to medication and behavioral treatment in the short term, evidence for long-term effectiveness remains elusive. We close with discussion of future directions and a call for greater understanding of relevant developmental processes in the attempt to promote optimal, generalized, and lasting treatments for this important and impairing neurodevelopmental disorder. PMID:25558298

  12. Repression predicts outcome following multidisciplinary treatment of chronic pain.

    PubMed

    Burns, J W

    2000-01-01

    This study examined whether repression predicts outcome following multidisciplinary treatment for chronic pain and whether links between anxiety and outcome are obscured by repressors. Ninety-three chronic pain patients completed a 4-week pain program. Lifting capacity, walking endurance, depression, pain severity, and activity were measured at pre- and posttreatment. Low-anxious, repressor, high-anxious, and defensive/high-anxious groups were formed from median splits of Anxiety Content (ACS) and Lie scales of the Minnesota Multiphasic Personality Inventory-2 (MMPI-2; Butcher, Dahlstrom, Graham, Tellegen, & Kaemmer, 1989). Significant ACS x Lie interactions were found for lifting capacity, depression, and pain severity changes. Planned comparisons showed that both repressors and high-anxious patients performed poorly on lifting capacity; repressors alone recovered poorly on depression and pain severity. Results imply that repression may interfere with the process and outcome of pain programs.

  13. Methadone maintenance treatment: outcomes from the Otago methadone programme.

    PubMed

    Dore, G M; Walker, J D; Paice, J R; Clarkson, S

    1999-11-26

    To provide information on methadone treatment outcomes for opiate-dependent individuals. Questionnaires and random urine tests were completed for 112 Otago clients comparing outcomes before and during methadone maintenance treatment. Treatment retention rates were high, with 86% of clients remaining on the programme six months or more. The number of clients on benefits reduced by almost 30% during treatment, with employment rates doubling from 19% to 40% (including attendance at educational programmes). For the 89 clients injecting opiates daily at initial presentation, 64% reported no opiate use in the three months prior to review. Of the remaining 36%, opiate use reduced significantly. Rates of sharing injecting equipment reduced by almost 90%. Almost 50% of cannabis users reduced their use from daily to less than daily use. Clients reporting no current use of illicit benzodiazepines increased by 85%. Heavy binge drinking weekly or more reduced by almost 75%. Use of other illicit drugs reduced by almost 90%. Drug-related convictions reduced by almost 60%, while accidental drug overdoses reduced by over 90%. The widespread benefits of methadone maintenance treatment demonstrated underline the importance of making quality methadone programmes readily accessible within the health system. Currently, there are long waiting lists and many individuals cannot gain access to active treatment. We believe the health system urgently needs to look at expanding existing services and/or establishing private methadone clinics similar to those in New South Wales.

  14. Directly Observed Therapy and Improved Tuberculosis Treatment Outcomes in Thailand

    PubMed Central

    Anuwatnonthakate, Amornrat; Limsomboon, Pranom; Nateniyom, Sriprapa; Wattanaamornkiat, Wanpen; Komsakorn, Sittijate; Moolphate, Saiyud; Chiengsorn, Navarat; Kaewsa-ard, Samroui; Sombat, Potjaman; Siangphoe, Umaporn; Mock, Philip A.; Varma, Jay K.

    2008-01-01

    Background The World Health Organization (WHO) recommends that tuberculosis (TB) patients receive directly observed therapy (DOT). Randomized controlled trials have not consistently shown that this practice improves TB treatment success rates. In Thailand, one of 22 WHO-designated high burden TB countries, patients may have TB treatment observed by a health care worker (HCW), family member, or no one. We studied whether DOT improved TB treatment outcomes in a prospective, observational cohort. Methods and Findings We prospectively collected epidemiologic data about TB patients treated at public and private facilities in four provinces in Thailand and the national infectious diseases hospital from 2004–2006. Public health staff recorded the type of observed therapy that patients received during the first two months of TB treatment. We limited our analysis to pulmonary TB patients never previously treated for TB and not known to have multidrug-resistant TB. We analyzed the proportion of patients still on treatment at the end of two months and with treatment success at the end of treatment according to DOT type. We used propensity score analysis to control for factors associated with DOT and treatment outcome. Of 8,031 patients eligible for analysis, 24% received HCW DOT, 59% family DOT, and 18% self-administered therapy (SAT). Smear-positive TB was diagnosed in 63%, and 21% were HIV-infected. Of patients either on treatment or that defaulted at two months, 1601/1636 (98%) patients that received HCW DOT remained on treatment at two months compared with 1096/1268 (86%) patients that received SAT (adjusted OR [aOR] 3.8; 95% confidence interval [CI] 2.4–6.0) and 3782/3987 (95%) patients that received family DOT (aOR 2.1; CI, 1.4–3.1). Of patients that had treatment success or that defaulted at the end of treatment, 1369/1477 (93%) patients that received HCW DOT completed treatment compared with 744/1074 (69%) patients that received SAT (aOR 3.3; CI, 2.4–4.5) and

  15. Protein-tyrosine phosphatase activity regulates osteoclast formation and function: inhibition by alendronate.

    PubMed Central

    Schmidt, A; Rutledge, S J; Endo, N; Opas, E E; Tanaka, H; Wesolowski, G; Leu, C T; Huang, Z; Ramachandaran, C; Rodan, S B; Rodan, G A

    1996-01-01

    Alendronate (ALN), an aminobisphosphonate used in the treatment of osteoporosis, is a potent inhibitor of bone resorption. Its molecular target is still unknown. This study examines the effects of ALN on the activity of osteoclast protein-tyrosine phosphatase (PTP; protein-tyrosine-phosphate phosphohydrolase, EC 3.1.3.48), called PTPepsilon. Using osteoclast-like cells generated by coculturing mouse bone marrow cells with mouse calvaria osteoblasts, we found by molecular cloning and RNA blot hybridization that PTPepsilon is highly expressed in osteoclastic cells. A purified fusion protein of PTPepsilon expressed in bacteria was inhibited by ALN with an IC50 of 2 microM. Other PTP inhibitors--orthovanadate and phenylarsine oxide (PAO)-inhibited PTPepsilon with IC50 values of 0.3 microM and 18 microM, respectively. ALN and another bisphosphonate, etidronate, also inhibited the activities of other bacterially expressed PTPs such as PTPsigma and CD45 (also called leukocyte common antigen). The PTP inhibitors ALN, orthovanadate, and PAO suppressed in vitro formation of multinucleated osteoclasts from osteoclast precursors and in vitro bone resorption by isolated rat osteoclasts (pit formation) with estimated IC50 values of 10 microM, 3 microM, and 0.05 microM, respectively. These findings suggest that tyrosine phosphatase activity plays an important role in osteoclast formation and function and is a putative molecular target of bisphosphonate action. Images Fig. 2 Fig. 3 PMID:8610169

  16. Targeted depletion of tumour-associated macrophages by an alendronate-glucomannan conjugate for cancer immunotherapy.

    PubMed

    Zhan, Xiudan; Jia, Lixin; Niu, Yiming; Qi, Haixia; Chen, Xiuping; Zhang, Qingwen; Zhang, Junfeng; Wang, Yitao; Dong, Lei; Wang, Chunming

    2014-12-01

    Tumour-associated macrophages (TAMs) are a set of macrophages residing in the tumour microenvironment. They play essential roles in mediating tumour angiogenesis, metastasis and immune evasion. Delivery of therapeutic agents to eliminate TAMs can be a promising strategy for cancer immunotherapy but an efficient vehicle to target these cells is still in pressing need. In this study, we developed a bisphosphonate-glucomannan conjugate that could efficiently target and specifically eliminate TAMs in the tumour microenvironment. We employed the polysaccharide from Bletilla striata (BSP), a glucomannan affinitive for macrophages that express abundant mannose receptors, to conjugate alendronate (ALN), a bisphosphonate compound with in vitro macrophage-inhibiting activities. In both in vitro and in vivo tests, the prepared ALN-BSP conjugate could preferentially accumulate in macrophages and induced them into apoptosis. In the subcutaneous S180 tumour-bearing mice model, the treatment using ALN-BSP effectively eliminated TAMs, remarkably inhibited angiogenesis, recovered local immune surveillance, and eventually suppressed tumour progression, without eliciting any unwanted effect such as systematic immune response. Interestingly, ALN alone failed to exhibit any anti-TAM activity in vivo, probably because this compound was susceptible to the mildly acidic tumour microenvironment. Taken together, these results demonstrate the potential of ALN-BSP as a safe and efficient tool targeted at direct depletion of TAMs for cancer immunotherapy.

  17. Brainstem encephalitis: etiologies, treatment, and predictors of outcome

    PubMed Central

    Tan, Ik Lin; Mowry, Ellen M.; Steele, Sonya U.; Pardo, Carlos A.; McArthur, Justin C.; Nath, Avindra

    2016-01-01

    Brainstem encephalitis (BE) is an uncommon condition. We sought to characterize clinical presentations, etiologies, response to treatment, and predictors of outcome. We performed a retrospective review of non–HIV infected patients diagnosed with BE at Johns Hopkins Hospital (January 1997–April 2010). We characterized clinical and paraclinical features, and used regression models to assess associations with poor outcome. BE was diagnosed in 81 patients. An etiology was identified in 58 of 81 (71.6 %) of cases, most of which were confirmed or probable inflammatory/autoimmune conditions. Of the remaining 23 cases in which a specific diagnosis remained undefined, clinical presentation, CSF, neuroimaging studies, and outcomes were similar to the inflammatory/autoimmune group. Brain biopsy identified a specific diagnosis in 7 of 14 patients (50 %). Fifteen patients (18.5 %) either died or had a poor outcome. In multivariate logistic regression models, a higher CSF protein (per 5 mg/dl, OR = 1.11, 95 % CI: 1.03–1.20), a higher CSF glucose (per 5 mg/dl, OR = 1.36, 95 % CI: 1.09–1.70), and higher serum glucose (per 5 mg/dl, OR = 1.27, 95 % CI: 1.06–1.52) were independently associated with increased odds of poor outcome. Inflammatory and non-infectious conditions accounted for most cases of BE. Higher CSF protein and glucose were independently associated with poor outcome. In immunocompetent patients with BE of undefined etiology despite extensive investigation, a trial of immunosuppressive treatment may be warranted, though deterioration clinically or on magnetic resonance imaging should prompt a brain biopsy. PMID:23749332

  18. The Australian Treatment Outcome Study (ATOS): what have we learnt about treatment for heroin dependence?

    PubMed

    Darke, Shane; Ross, Joanne; Teesson, Maree

    2007-01-01

    Opioids make the single largest contribution to illicit drug-related mortality and morbidity worldwide In this paper we reflect upon what has been learnt regarding treatment outcome and the natural history of heroin use from the Australian Treatment Outcome Study (ATOS). We focus on what we knew prior to ATOS, what ATOS revealed that is novel, and the implications for research, practice and policy. ATOS provided strong evidence for sustained improvement attributable to treatment across the three years of the study. It is argued that treatment for heroin dependence is money well spent, and leads to clear and sustained benefits to both heroin users and society.

  19. Acute Coronary Syndromes in Women: Recent Treatment Trends and Outcomes

    PubMed Central

    Graham, Garth

    2016-01-01

    In the USA and internationally, women experience farranging differences with respect to acute coronary syndrome (ACS) and myocardial infarction (MI). Women suffer from more comorbidities than men, such as smoking, obesity, hypertension, diabetes, and poor mental health. They some-times exhibit atypical MI presentation symptoms and are overall less likely to present with chest pain. Women are more likely than men to encounter delays between the onset of symptoms and arrival at the hospital or to guideline treatment. The use of various surgical and pharmacological treatments, including revascularization approaches, also differs. Women, on average, have worse outcomes than men following MI, with more complications, higher mortality rates, and poorer recovery. Internationally, outcomes are similar despite various differences in health care and culture in non-US countries. In this review, we detail differences regarding ACS and MI in women, describing their complex correlations and discussing their possible causes. Educational approaches that are tailored to women might help to reduce the incidence of ACS and MI, as well as outcomes following hospitalization. Although outcomes following acute MI have been improving over the years, women may require special consideration in order to see continued improvement. PMID:26884685

  20. The effect of alendronate (Fosamax) and implant surface on bone integration and remodeling in a canine model.

    PubMed

    Frenkel, S R; Jaffe, W L; Valle, C D; Jazrawi, L; Maurer, S; Baitner, A; Wright, K; Sala, D; Hawkins, M; Di Cesare, P E

    2001-01-01

    Patients at high risk for osteoporosis and its associated morbidity, including postmenopausal women, are being pharmacologically managed to stabilize and improve bone mass. Alendronate sodium (Fosamax) is a commonly used antiresorptive agent effective in osteopenic women for reducing bone resorption, increasing bone density, and decreasing fracture incidence. With the increased incidence of alendronate-treated women who are undergoing hip replacement or fracture repair by prosthesis placement, data are needed to predict how alendronate affects host bone integration with uncemented surfaces. The aim of this study was to determine the effect of alendronate on new bone formation and attachment to implant surfaces in a normal and simulated estrogen-deficient, calcium-deficient canine model, using an implantable bone growth chamber. Alendronate did not affect host bone integration to surfaces commonly used in uncemented total joint arthroplasty, but there were significant differences dependent solely on the type of surface.

  1. Treatment outcomes in 4 modes of orthodontic practice.

    PubMed

    Poulton, Donald; Vlaskalic, Vicki; Baumrind, Sheldon

    2005-03-01

    This study is a continuation of a previously published report on the outcome of orthodontic treatment provided in offices representing different modes of practice. The sample consisted of duplicate pretreatment (T1) and posttreatment (T2) dental casts of 348 patients from traditional private orthodontic practices (5 offices, 134 patients), company-owned practices (5 offices, 107 patients), offices associated with practice-management organizations (2 offices, 60 patients), and general dental practices (2 offices, 47 patients). Methods were used to obtain random, representative samples from each office, starting with lists of patients who were treated consecutively with full fixed orthodontic appliances. The dental casts were measured by 2 independent judges who used the unweighted PAR score. Good interjudge agreement was shown on the initial casts, but the agreement was not as strong on the final casts. The measurements showed that treatment outcomes were generally satisfactory, although some significant differences between offices and management modes were shown.

  2. Treatment outcome and prognostic indices in patients with hyperglycemic emergencies

    PubMed Central

    Ezeani, IU; Eregie, A; Ogedengbe, OS

    2013-01-01

    Objective The objective of this study is to assess the treatment outcomes in patients with hyperglycemic emergencies and to ascertain the factors associated with outcome, with emphasis on the determinants of outcome. Method A total of 105 patients admitted to the Accident and Emergency unit, who fulfilled the criteria for hyperglycemic emergencies, were selected. The information extracted included sociodemographic, clinical, and laboratory data, as well as hospitalization outcome. Results Of the 105 subjects that participated in the study, hyperosmolar hyperglycemic nonketotic state (HHNK) was seen in 50% (53) of the subjects, while diabetic ketoacidosis (DKA) was seen in 31% (29), normo-osmolar nonketotic hyperglycemic state (NNHS) in 12% (13), and mixed hyperglycemic emergency in 7% (10) of the subjects. The overall mortality rate in this study was 4.8%. Three deaths were recorded in patients with HHNK, while DKA and NNHS each had one death. Three of the deaths occurred within the first 24 hours of admission while the other two were more than 24 hours after admission. The mean (standard deviation) total duration of hospital stay was 24.2 days (SD), and the range of stay was 0.5–88 days. Conclusion The most common type of hyperglycemic emergency seen in this study was HHNK. Also, the presence of infection, and sex of the study subject, were significant determinants of outcome in this study. PMID:23983480

  3. Genetics of long-term treatment outcome in bipolar disorder.

    PubMed

    Fabbri, Chiara; Serretti, Alessandro

    2016-02-04

    Bipolar disorder (BD) shows one of the strongest genetic predispositions among psychiatric disorders and the identification of reliable genetic predictors of treatment response could significantly improve the prognosis of the disease. The present study investigated genetic predictors of long-term treatment-outcome in 723 patients with BD type I from the STEP-BD (Systematic Treatment Enhancement Program for Bipolar Disorder) genome-wide dataset. BD I patients with >6months of follow-up and without any treatment restriction (reflecting a natural setting scenario) were included. Phenotypes were the total and depressive episode rates and the occurrence of one or more (hypo)manic/mixed episodes during follow-up. Quality control of genome-wide data was performed according to standard criteria and linear/logistic regression models were used as appropriate under an additive hypothesis. Top genes were further analyzed through a pathway analysis. Genes previously involved in the susceptibility to BD (DFNB31, SORCS2, NRXN1, CNTNAP2, GRIN2A, GRM4, GRIN2B), antidepressant action (DEPTOR, CHRNA7, NRXN1), and mood stabilizer or antipsychotic action (NTRK2, CHRNA7, NRXN1) may affect long-term treatment outcome of BD. Promising findings without previous strong evidence were TRAF3IP2-AS1, NFYC, RNLS, KCNJ2, RASGRF1, NTF3 genes. Pathway analysis supported particularly the involvement of molecules mediating the positive regulation of MAPK cascade and learning/memory processes. Further studies focused on the outlined genes may be helpful to provide validated markers of BD treatment outcome.

  4. Outcomes of Treatment of Nonagenarians With Severe Aortic Stenosis.

    PubMed

    Mack, Molly Claire; Szerlip, Molly; Herbert, Morley A; Akram, Siddique; Worley, Christina; Kim, Rebeca J; Prince, Brandon A; Harrington, Katherine B; Mack, Michael J; Holper, Elizabeth M

    2015-07-01

    Because nonagenarians with aortic stenosis (AS) often present as frail with more comorbid conditions, long-term outcomes and quality of life are important treatment considerations. The aim of this report is to describe survival and functional outcomes of nonagenarians undergoing treatment for AS by surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). This is a retrospective analysis of all patients aged 90 years or more undergoing treatment for AS between 2007 and 2013 at two centers. Outcomes were compared between SAVR and TAVR. Long-term survival was compared with an age- and sex-matched population from the Social Security Actuarial Life Table. In all, 110 patients underwent treatment for isolated AS (20 SAVR and 90 TAVR). Mean age was 91.85 ± 1.80 years, and 50.9% were female. The Society of Thoracic Surgeons mean predicted risk of mortality was 11.11% ± 5.74%. Operative mortality was 10.9% (10.0% SAVR; 11.1% TAVR); 2.7% of patients had a stroke. The TAVR patients were more likely to be discharged home (75.9% versus 55.6% for SAVR, p = 0.032). Mean follow-up was 1.8 ± 1.5 years, with a 1-year and 5-year survival of 78.7% and 45.3%, respectively, which approximated the US actuarial survival. There was a significant improvement in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire at 1 year compared with baseline. Treatment of AS approximates natural life expectancy in select nonagenarians, with no significant difference in long-term survival between SAVR and TAVR. Importantly, patient quality of life improved at 1 year. With appropriate selection, nonagenarians with severe AS can benefit from treatment. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  5. The Tennessee study: factors affecting treatment outcome and healing time following nonsurgical root canal treatment.

    PubMed

    Azim, A A; Griggs, J A; Huang, G T-J

    2016-01-01

    To determine factors that may influence treatment outcome and healing time following root canal treatment. Root filled and restored teeth by pre-doctoral students were included in this study. Teeth/roots were followed-up regularly, and treatment outcome was evaluated at every follow-up appointment (healed, healing, uncertain or unsatisfactory). Host (age, immune condition, pulp/periapical diagnosis, tooth/root type, location and anatomy) and treatment factors (master apical file size, apical extension, voids and density of root filling) were recorded from patient dental records. Univariate, bivariate and multivariate analyses were performed to determine the impact of the factors on treatment outcomes and healing times. A total of 422 roots from 291 teeth met the inclusion criteria with a mean follow-up period of 2 years. The preoperative pulp condition, procedural errors during treatment, apical extension and density of root fillings significantly affected the treatment outcome. The average time required for a periapical lesion to heal was 11.78 months. The healing time increased in patients with compromised healing, patients older than 40 years, roots with Weine type II root canal systems, root canal systems prepared to a master apical file size <35, and roots with overextended fillings (P < 0.1). Multiple host and treatment factors affected the healing time and outcome of root canal treatment. Follow-up protocols should consider these factors before concluding the treatment outcome: patient's age, immune condition, as well as roots with overextended fillings, root canal systems with smaller apical preparations (size <35) or roots with complex canal systems. Intervention may be recommended if the treatment quality was inadequate or if patients became symptomatic. © 2015 International Endodontic Journal. Published by John Wiley & Sons Ltd.

  6. Does treatment of SDB in children improve cardiovascular outcome?

    PubMed

    Vlahandonis, Anna; Walter, Lisa M; Horne, Rosemary S C

    2013-02-01

    Sleep disordered breathing (SDB) is a common disorder in both adults and children and is caused by the obstruction of the upper airway during sleep. Unlike adults, most cases of paediatric SDB are due to the presence of enlarged tonsils and adenoids, thus the main treatment option is adenotonsillectomy (T&A). It is well known that obstructive sleep apnoea in adults increases the risk for hypertension, coronary artery disease and stroke, and there is now mounting evidence that SDB also has a significant impact on the cardiovascular system in children with reports of elevated blood pressure, endothelial dysfunction and altered autonomic cardiovascular control. As there is now substantial evidence that elevated blood pressure in childhood is carried on to adulthood it is important to know if treatment of SDB improves cardiovascular outcomes. Studies in adults have shown that treatment of SDB leads to improvements in cardiovascular function, including a reduction in pulmonary artery pressure, systemic blood pressure and endothelial dysfunction. However, studies exploring the outcomes of treatment of SDB in children on the cardiovascular system are limited and varied in their methodology and outcome measures. As a number of cardiovascular disturbances are sequelae of SDB, early detection and management could result in the reduction of elevated blood pressure in children, and consequently a reduction in cardiovascular morbidity in adulthood. The aim of this review is to summarise the findings of studies to date which have investigated the cardiovascular outcomes in children treated for SDB and to make recommendations for future management of this very common disease.

  7. Preparation and Biological Study of 68Ga-DOTA-alendronate

    PubMed Central

    Fakhari, Ashraf; Jalilian, Amir R.; Johari-Daha, Fariba; Shafiee-Ardestani, Mehdi; Khalaj, Ali

    2016-01-01

    Objective(s): In line with previous research on the development of conjugated bisphosphonate ligands as new bone-avid agents, in this study, DOTA-conjugated alendronate (DOTA-ALN) was synthesized and evaluated after labeling with gallium-68 (68Ga). Methods: DOTA-ALN was synthesized and characterized, followed by 68Ga-DOTA-ALN preparation, using DOTA-ALN and 68GaCl3 (pH: 4-5) at 92-95° C for 10 min. Stability tests, hydroxyapatite assay, partition coefficient calculation, biodistribution studies, and imaging were performed on the developed agent in normal rats. Results: The complex was prepared with high radiochemical purity (>99% as depicted by radio thin-layer chromatography; specific activity: 310-320 GBq/mmol) after solid phase purification and was stabilized for up to 90 min with a log P value of -2.91. Maximum ligand binding (65%) was observed in the presence of 50 mg of hydroxyapatite; a major portion of the activity was excreted through the kidneys. With the exception of excretory organs, gastrointestinal tract organs, including the liver, intestine, and colon, showed significant uptake; however, the bone uptake was low (<1%) at 30 min after the injection. The data were also confirmed by sequential imaging at 30-90 min following the intravenous injection. Conclusion: The high solubility and anionic properties of the complex led to major renal excretion and low hydroxyapatite uptake; therefore, the complex failed to demonstrate bone imaging behaviors. PMID:27408898

  8. Alendronate functionalized mesoporous hydroxyapatite nanoparticles for drug delivery

    SciTech Connect

    Li, Dongdong; Zhu, Yuntao; Liang, Zhiqiang

    2013-06-01

    Highlights: ► The synthesized mesoporous hydroxyapatite has nanostructure and bioactivity. ► The materials have high surface area and amino group. ► The materials show higher drug loading and slower release rate than pure HAP. - Abstract: Mesoporous nanosized hydroxyapatite (HAP) functionalized by alendronate (ALN) was synthesized using cationic surfactant CTAB as template. The structural, morphological and textural properties were fully characterized by X-ray diffraction (XRD), transmission electron microscopy (TEM), Fourier transform infrared spectroscopy (FT-IR) and N{sub 2} adsorption/desorption. Then the obtained materials were performed as drug delivery carriers using ibuprofen (IBU) as a model drug to investigate their drug storage/release properties in simulated body fluid (SBF). The materials showed relatively slower release rate compared with HAP due to the ionic interaction between -NH{sub 3}{sup +} on the matrix and -COO{sup −}belongs to IBU. The system provides a new concept for improving the drug loading or slowing down the release rate.

  9. Identifying predictors of treatment outcome in a drug court program.

    PubMed

    Roll, John M; Prendergast, Michael; Richardson, Kimberly; Burdon, William; Ramirez, Anthony

    2005-01-01

    Drug courts are popular for dealing with drug-abusing offenders. However, relatively little is known about participant characteristics that reliably predict either success or failure in these treatment settings. In this article, we report on 99 individuals who were enrolled in a drug court program (approximately one-half of whom successfully completed the program). Using, logistic regression techniques we identified 2 significant predictors of outcome. First, individuals who were employed at the time of their enrollment into the drug court program were more likely to successfully complete the treatment program. Second, individuals with a history of illicit intravenous drug use were less likely to complete the program.

  10. Cryotherapy in Treatment of Keloids: Evaluation of Factors Affecting Treatment Outcome

    PubMed Central

    Barara, Meenu; Mendiratta, Vibhu; Chander, Ram

    2012-01-01

    Background: Keloids are cosmetically disfiguring benign fibrous outgrowths, which present as a major therapeutic dilemma due to their frequent recurrence. Despite a wide therapeutic armamentarium available for these scars, none has been found to be completely effective and satisfactory. Cryosurgery has offered some promise in the treatment of keloids.We conducted this study to evaluate the effect of cryotherapy in treatment of keloids and to relate the treatment outcome with the clinico-etiological factors. Materials and Methods: A hospital-based interventional study was conducted in 30 patients of keloids. Patients received two freeze thaw cycles of 15 seconds each at four weekly intervals for six sessions or flattening greater than 75%; whichever occurred earlier. Patients were assessed after three treatment sessions and at treatment completion regarding thickness and firmness of lesions. Patient satisfaction scale was used to evaluate the treatment outcome at completion of six treatment sessions. Paired Students t-test and Analysis of variance (ANOVA) were used for statistical analysis. Results: Average flattening noted after 3 and 6 sessions of cryotherapy was 30.76% and 58.13%, respectively. The duration of lesions and thickness of keloids correlated significantly with the result of treatment. The site and aetiology did not influence the outcome of cryosurgical treatment. Conclusion: Cryotherapy seems to be an effective treatment modality for keloids of recent onset, particularly smaller lesions. Duration and thickness of the keloids were found to be the most important factors in determining treatment outcome with cryotherapy in our study. Larger studies are, however, required to confirm the efficacy of this treatment modality and to validate our findings of the factors affecting treatment outcome. PMID:23112514

  11. Multihospital System Membership and Patient Treatments, Expenditures, and Outcomes

    PubMed Central

    Madison, Kristin

    2004-01-01

    Objective To determine the relationship between hospital membership in systems and the treatments, expenditures, and outcomes of patients. Data Sources The Medicare Provider Analysis and Review dataset, for data on Medicare patients admitted to general medical-surgical hospitals between 1985 and 1998 with a diagnosis of acute myocardial infarction (AMI); the American Hospital Association Annual Survey, for data on hospitals. Study Design A multivariate regression analysis. An observation is a fee-for-service Medicare AMI patient admitted to a study hospital. Dependent variables include patient transfers, catheterizations, angioplasties or bypass surgeries, 90-day mortality, and Medicare expenditures. Independent variables include system participation, other admission hospital and patient traits, and hospital and year fixed effects. The five-part system definition incorporates the size and location of the index admission hospital and the size and distance of its partners. Principal Findings While the effects of multihospital system membership on patients are in general limited, patients initially admitted to small rural system hospitals that have big partners within 100 miles experience lower mortality rates than patients initially admitted to independent hospitals. Regression results show that to the extent system hospital patients experience differences in treatments and outcomes relative to patients of independent hospitals, these differences remain even after controlling for the admission hospital's capacity to provide cardiac services. Conclusions Multihospital system participation may affect AMI patient treatment and outcomes through factors other than cardiac service offerings. Additional investigation into the nature of these factors is warranted. PMID:15230926

  12. Treatment effectiveness outcome research in adult partial hospitalization.

    PubMed

    Gantner, R K; Burton, D; Story, L

    1992-06-01

    The pilot study at Charter Kingwood was designed as an integral part of continuous quality improvement. Research focused on patient appropriateness and outcome treatment results. The Day Therapy Appropriateness Scale was administered along with pre and post tests of the Index of Self Esteem (ISE) and General Contentment Scale (GCS). Other instruments included a Patient Satisfaction Survey and alumni quarterly follow-up checklist letter. The outcome study demonstrates that patients were appropriately placed in treatment and improved with treatment. Results showed that patients improved 20% after 2 weeks of intensive group therapies. The Patient Satisfaction Survey had 17 items and 4 categories to select degrees of satisfaction or dissatisfaction with the overall program, staff, therapy groups, and individualized treatment goals. Results supported a 90% overall satisfaction with services provided. An alumni quarterly follow-up emphasizing postdischarge planning and aftercare verified that 96.3% of participants benefited from the program, 82% participated in aftercare, and 98.3% would recommend significant others for treatment.

  13. Topical Treatment of Onychomycosis and Clinically Meaningful Outcomes.

    PubMed

    Gupta, Aditya K; Korotzer, Andrew

    2016-10-01

    Although a completely normal nail would be the ideal outcome when treating onychomycosis, this is not always achievable and long treatment courses or patient expectations can impact patient adherence. We analyzed cure rates from a number of subpopulations derived from the two pivotal phase III studies with efinaconazole topical solution (10%) to provide some insights into clinically meaningful treatment outcomes and support for effective long-term management programs. Efinaconazole affords greater efficacy in milder disease, female patients, and those patients whose disease is relatively recent and confined to the great toenail, following 48 weeks' treatment. With longer treatment courses, similar results may be achieved in other subpopulations. Clinically meaningful results (a 40% improvement in the involvement of the diseased nail) were achieved with efinaconazole within six months in half the patients treated, and in over 90% of patients by study end. A greater proportion of female patients achieved clinically meaningful results at six months, although treatment success did not seem to be influenced by baseline disease severity. The majority of patients treated with efinaconazole could expect to see clinically meaningful results within six months.

    J Drugs Dermatol. 2016;15(10):1260-1266.

  14. Clinical symptoms and microbiological outcomes in tuberculosis treatment trials.

    PubMed

    Bark, C M; Dietze, R; Okwera, A; Quelapio, M I; Thiel, B A; Johnson, J L

    2011-11-01

    During a recent Food and Drug Administration workshop on clinical trials to evaluate new TB drugs, questions were raised regarding the use of bacteriologic endpoints such as treatment failure and relapse as measures of improvement in health status and long term outcome after treatment. FDA scientists asked how patients' clinical signs and symptoms changed during therapy, noting that while such information is usually collected during clinical trials, it is not often reported. We analyzed data from an international phase 3 TB treatment trial that included systematic assessments of symptoms. The percentage of subjects with self-reported symptoms at baseline ranged from 30% for dyspnea to 81% for cough, with 51% reporting fever. During therapy, fever, sweats, and dyspnea decreased most rapidly, with near resolution by the end of therapy. Chest pain and cough resolved more slowly; 13% of subjects reported cough at six months. Symptom resolution during treatment did not differ between those who relapsed and those who did not. Among those with microbiological relapse, symptoms returned with significant increases in the proportion with fever, cough, and chest pain. At the time of relapse, cough was the most frequent symptom, occurring in 75% of subjects who relapsed but only 12% of those who did not. Our data support the continued use of bacteriologic endpoints based on sputum culture as surrogate measures of the relief of symptoms, improvement in health status and favorable long term treatment outcome in TB drug trials. Copyright © 2011 Elsevier Ltd. All rights reserved.

  15. Treatment of substance abuse during pregnancy and infant outcome.

    PubMed

    Little, Bertis B; Snell, Laura M; Van Beveren, Toosje T; Crowell, R Becca; Trayler, Stacey; Johnston, Walter L

    2003-07-01

    The objective of this study is to analyze the effects of residential substance abuse treatment on pregnancy outcome among gravidas in a gender-specific program. All clients (cases) who entered a residential substance abuse program for pregnant and postpartum women were eligible for inclusion in the study (n=95). Only those who were in treatment at the time of delivery were included in the present analysis (n=57). Two comparison groups were used: (1) substance abusers who received no treatment during pregnancy (positive control group) and (2) pregnant women who were not substance abusers (negative control group). Cases were matched to controls on ethnicity (negative and positive controls) and drug of choice (positive controls only). Medical records were reviewed and abstracted for cases and controls. The primary drug of choice was cocaine for 56% of clients in the study, heroin 15.8%, and alcohol 10.8%. Average length of time in treatment before delivery was 11.7 weeks. The frequency of pregnancy complications allowing treatment and position controls was significantly higher than the negative control group (p<0.0001). The frequency of perinatal infant complications was increased among treatment group infants (p<0.0001). Two infants in the treatment group were positive for a substance of abuse at birth. In the treatment versus positive control group, mean birth weight (BW) was 3227 versus 2800 g (p<0.01), estimated gestational age (EGA) was 38.9 versus 39 weeks, average head circumference (FOC) was 33.8 versus 32.5 cm (p<0.05), and mean birth length (BLT) was 48.7 cm versus 46.9 (p<0.05). No significant differences were found between treatment and negative control groups. Maternal syphilis was increased in frequency in the positive control group compared with the negative control group (p<0.07). Thirty-percent of mothers had sexually transmitted diseases (STDs) for which infants were at risk and treated prophylactically; no infant in the treatment group contracted a

  16. Acupuncture fails to improve treatment outcome in alcoholics.

    PubMed

    Worner, T M; Zeller, B; Schwarz, H; Zwas, F; Lyon, D

    1992-06-01

    Fifty-six alcoholics (49 male, 7 female) of lower socioeconomic class attending an outpatient treatment program in Brooklyn, New York were prospectively randomized to one of three treatment group: point-specific acupuncture, sham transdermal stimulation or standard care (control). One third of the subjects reported a history of drug use in addition to alcohol. Results in this small sample showed no significant differences in attendance at Alcoholics Anonymous meetings, number of outpatients sessions attended, number of weeks in either the study or in the outpatient program, number of persons completing treatment or in the number of relapses. It is therefore concluded that in this small racially mixed sample of urban outpatient alcoholics, fixed point-specific standardized acupuncture did not improve outcome. We caution against the routine use of this treatment until more randomized controlled trials demonstrate a beneficial effect.

  17. [Personality changes of neurotic patients as outcome of the treatment].

    PubMed

    Jodzio, K

    1993-01-01

    The present article attempted to assess the importance of outcomes which appeared during the treatment of 30 neurotic patients. This study specially concentrates on measures of emotional empathy, self-confidence and introspection. There were two surveys in the clinical group: before and after the treatment was completed. Data were compared with a control group, also consisting of 30 persons (15 male and 15 female) matched for age and education. All patients attending group psychotherapy were also treated by pharmacotherapy. As it appeared from the analysis before treatment high empathy in patients was found, but this declined after therapy, however it was still significantly higher than in the control group. The first survey revealed also that patients demonstrated lower levels of self-confidence and introspection. After treatment there were no important differences between the groups. Relationships between the studied qualities were not statistically significant.

  18. Effect of heparin and alendronate coating on titanium surfaces on inhibition of osteoclast and enhancement of osteoblast function

    SciTech Connect

    Moon, Ho-Jin; Yun, Young-Pil; Han, Choong-Wan; Kim, Min Sung; Kim, Sung Eun; Bae, Min Soo; Kim, Gyu-Tae; Choi, Yong-Suk; Hwang, Eui-Hwan; Lee, Joon Woo; Lee, Jin-Moo; Lee, Chang-Hoon; Kim, Duck-Su; Kwon, Il Keun

    2011-09-23

    Highlights: {yields} We examine bone metabolism of engineered alendronate attached to Ti surfaces. {yields} Alendronate-immobilized Ti enhances activation of osteoblast differentiation. {yields} Alendronate-immobilized Ti inhibits osteoclast differentiation. {yields} Alendronate-immobilized Ti may be a bioactive implant with dual functions. -- Abstract: The failure of orthopedic and dental implants has been attributed mainly to loosening of the implant from host bone, which may be due to weak bonding of the implant material to bone tissue. Titanium (Ti) is used in the field of orthopedic and dental implants because of its excellent biocompatibility and outstanding mechanical properties. Therefore, in the field of materials science and tissue engineering, there has been extensive research to immobilize bioactive molecules on the surface of implant materials in order to provide the implants with improved adhesion to the host bone tissue. In this study, chemically active functional groups were introduced on the surface of Ti by a grafting reaction with heparin and then the Ti was functionalized by immobilizing alendronate onto the heparin-grafted surface. In the MC3T3-E1 cell osteogenic differentiation study, the alendronate-immobilized Ti substrates significantly enhanced alkaline phosphatase activity (ALP) and calcium content. Additionally, nuclear factor kappa B ligand (RANKL)-induced osteoclast differentiation of RAW264.7 cells was inhibited with the alendronate-immobilized Ti as confirmed by TRAP analysis. Real time PCR analysis showed that mRNA expressions of osteocalcin and osteopontin, which are markers for osteogenesis, were upregulated in MC3T3-E1 cells cultured on alendronate-immobilized Ti. The mRNA expressions of TRAP and Cathepsin K, markers for osteoclastogenesis, in RAW264.7 cells cultured on alendronate-immobilized Ti were down-regulated. Our study suggests that alendronate-immobilized Ti may be a bioactive implant with dual functions to enhance

  19. Predicting the Probable Outcome of Treatment in HCV Patients

    PubMed Central

    Navaneethan, Udayakumar; Kemmer, Nyingi

    2009-01-01

    Hepatitis C virus (HCV) is a major cause of chronic liver disease infecting more than 170 million people worldwide. HCV produces a wide gamut of manifestations varying from mild self-limiting disease to cirrhosis and hepatocellular carcinoma. A variety of viral, environmental and host genetic factors contribute to the clinical spectrum of patients infected with HCV and influence response to interferon (IFN) therapy. Predicting the probable outcome of treatment in patients with HCV infection has always been a challenging task. Treatment of HCV by pegylated interferon (peg-IFN) plus ribavirin eradicates the virus in approximately 60% of patients — HCV genotype 1 (42—51% response rates) and genotypes 2 and 3 (76—84% response rates); however, a significant number of patients do not respond to therapy or relapse following discontinuation of treatment or have significant side effects that preclude further treatment. Accurately predicting the patients who will respond to therapy is becoming increasingly important, both from the point of patient care and also with respect to the healthcare cost as clinicians need to continue treatment in patients who will respond and stop treatment in patients who are unlikely to respond. Viral RNA measurements and genotyping are used to optimize treatment as a low viral load and nongenotype 1 is more likely to be associated with sustained virological response (SVR). Rapid virological response (RVR) defined by undetectable HCV RNA at 4 weeks of treatment is increasingly being recognized as a powerful tool for predicting treatment response. A variety of host factors including single nuclear polymorphisms (SNPs) of IFN response genes, insulin resistance, obesity, ethnicity, human leukocyte antigens and difference in T-cell immune response has been found to modulate the response to antiviral treatment. The presence of severe fibrosis/cirrhosis on pretreatment liver biopsy predicts a poor response to treatment. Recent studies on gene

  20. The Treatment and Outcomes of Medial Malleolar Stress Fractures

    PubMed Central

    Irion, Val; Miller, Timothy L.; Kaeding, Christopher C.

    2014-01-01

    Context: The medial malleolus is considered a high-risk stress fracture and can be debilitating to the highly active or athletic populations. A range of treatment methods have been described with varying outcomes. Currently, there is no gold standard treatment option with optimal results described. Objective: A systematic search of the literature to determine treatment options and outcomes in medial malleolus stress fractures. Data Sources: OVID/Medline, EMBASE, and the Cochrane Library from 1950 to September 2013. Study Selection: Included studies mentioned treatment and outcomes of medial malleolus stress fractures. Study Design: Systematic review. Level of Evidence: Level 4. Data Extraction: The searches used combinations of the terms stress fracture, medial malleolus, management, and treatment. Two authors independently reviewed the selected articles and created individual tables, which were later compiled into a master table for final analysis. Results: Six retrospective case series were identified (n = 31 patients). Eighty percent (25/31) of patients were men, with an average age of 24.5 years. Ninety percent (28/31) of patients were at least involved in recreational athletics. All patients were able to return to sport. Complications were seen in both groups ranging from minor stiffness to nonunion requiring open reduction internal fixation. Conclusion: Nonoperative and operative interventions have proven to be successful with regard to healing and return to play for medial malleolar stress fractures in the recreational and competitive athlete. However, early operative intervention can possibly create a higher likelihood of early healing, decrease in symptoms, and return to play. PMID:25364485

  1. Intracranial pediatric aneurysms: endovascular treatment and its outcome.

    PubMed

    Saraf, Rashmi; Shrivastava, Manish; Siddhartha, Wuppalapati; Limaye, Uday

    2012-09-01

    The aim of this study was to analyze the location, clinical presentation, and morphological characteristics of pediatric aneurysms and the safety, feasibility, and durability of endovascular treatment. The authors conducted a retrospective study of all cases involving patients 18 years old or younger who underwent endovascular treatment for pediatric aneurysms at their institution between July 1998 and July 2010. The clinical presentation, aneurysm location, endovascular management, and treatment outcome were studied. During the study period, 23 pediatric patients (mean age 13 years, range 2 months-18 years) were referred to the authors' department and underwent endovascular treatment for aneurysms. The aneurysms were saccular in 6 cases, dissecting in 4, infectious in 5, and giant partially thrombosed lesions in 8. Fourteen of the aneurysms were ruptured, and 9 were unruptured. Thirteen were in the anterior circulation and 10 in the posterior circulation. The most common location in the anterior circulation was the anterior communicating artery; in the posterior circulation, the most common location was the basilar artery. Saccular aneurysms were the most common type in the anterior circulation; and giant partially thrombosed and dissecting aneurysms were the most common types in the posterior circulation. Coil embolization was performed in 7 cases, parent vessel sacrifice in 10, flow reversal in 3, glue embolization in 2, and stent placement in 1. Immediate angiographic cure was seen in 21 (91%) of 23 patients. Complications occurred in 4 patients, 3 of whom eventually had a good outcome. No patient died. Overall, a favorable outcome was seen in 22 (96%) of 23 patients. Follow-up showed stable occlusion of aneurysms in 96% of the patients. Pediatric aneurysms are rare. Their clinical presentation varies from intracranial hemorrhage to mass effect. They may also be found incidentally. Among pediatric patients with aneurysms, giant aneurysms are relatively common

  2. Outcome of surgical treatment of arthrofibrosis following ligament reconstruction.

    PubMed

    Said, Sinan; Christainsen, Svend Erik; Faunoe, Peter; Lund, Bent; Lind, Martin

    2011-10-01

    Clinical outcome following surgical treatment and intensive physiotherapy was evaluated in patients with arthrofibrosis as a complication to varying knee-ligament reconstructions. From 2003 to 2007, 31 patients underwent surgery for arthrofibrosis as a postoperative complication following knee-ligament reconstruction. Treatment for reduced range of motion consisted of forced manipulation or arthroscopic arthrolysis followed by intensive physiotherapy. Twenty-seven patients (12 men and 15 women; median age 35(12-70) years) were followed up. Objective examination, Pain, KOOS and Tegner scores were used to evaluate the clinical outcome at follow-up. Fourteen patients were treated with forced manipulation alone, and the remaining thirteen were treated with forced manipulation and arthroscopic arthrolysis. The patients' median follow-up was 51 months (19-73 months). Median interval between primary surgery and surgical release was 4 (1-32) months. Median range of motion (ROM) improved from -0°(0 to 20) to 0°(+2-9) in extension deficit and from 90°(40-145) to 130°(90-155) in flexion. Mean KOOS score were symptoms 63, pain 72, ADL 77, sport 42, QOL 45. Median Tegner score was 4 (2-9). Surgical arthrolysis combined with intensive physiotherapy improved range of motion to nearly normal values. Subjective outcome scores revealed relatively poor outcome levels compared to uncomplicated knee-ligament reconstruction. Predictors of poor outcome were global arthrofibrosis and greater than 6-month time interval from primary reconstruction and surgical release. Retrospective clinical case series, Level IV.

  3. Microarchitectural Deterioration of Cortical and Trabecular Bone: Differing Effects of Denosumab and Alendronate

    PubMed Central

    Seeman, Ego; Delmas, Pierre D; Hanley, David A; Sellmeyer, Deborah; Cheung, Angela M; Shane, Elizabeth; Kearns, Ann; Thomas, Thierry; Boyd, Steven K; Boutroy, Stephanie; Bogado, Cesar; Majumdar, Sharmila; Fan, Michelle; Libanati, Cesar; Zanchetta, Jose

    2015-01-01

    The intensity of bone remodeling is a critical determinant of the decay of cortical and trabecular microstructure after menopause. Denosumab suppresses remodeling more than alendronate, leading to greater gains in areal bone mineral density (aBMD). These greater gains may reflect differing effects of each drug on bone microarchitecture and strength. In a phase 2 double-blind pilot study, 247 postmenopausal women were randomized to denosumab (60mg subcutaneous 6 monthly), alendronate (70mg oral weekly), or placebo for 12 months. All received daily calcium and vitamin D. Morphologic changes were assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT) at the distal radius and distal tibia and QCT at the distal radius. Denosumab decreased serum C-telopeptide more rapidly and markedly than alendronate. In the placebo arm, total, cortical, and trabecular BMD and cortical thickness decreased (−2.1% to −0.8%) at the distal radius after 12 months. Alendronate prevented the decline (−0.6% to 2.4%, p = .051 to < .001 versus placebo), whereas denosumab prevented the decline or improved these variables (0.3% to 3.4%, p < .001 versus placebo). Changes in total and cortical BMD were greater with denosumab than with alendronate (p ≤ .024). Similar changes in these parameters were observed at the tibia. The polar moment of inertia also increased more in the denosumab than alendronate or placebo groups (p < .001). Adverse events did not differ by group. These data suggest that structural decay owing to bone remodeling and progression of bone fragility may be prevented more effectively with denosumab. PMID:20222106

  4. Treatment of chronic stuttering: outcomes from a student training clinic.

    PubMed

    Block, Susan; Onslow, Mark; Packman, Ann; Gray, Belinda; Dacakis, Georgia

    2005-01-01

    It has been suggested that one way to increase speech pathologists' confidence in working with people who stutter is to provide them with relevant and stimulating clinical experiences during their professional preparation. This paper describes a treatment programme for adults who stutter that is conducted by speech pathology students, under supervision, in an Australian university setting. The aim of the research presented here was to establish speech outcomes for this programme, and to determine whether the programme meets benchmarks set by reports of similar programmes, in addition to providing mentorship for student clinicians. Participants were 78 adults who were treated in one of five consecutive treatment programmes during a 3-year period. The treatment was a traditional intensive speech restructuring treatment known as Smooth Speech, conducted over a 5-day period. Speech assessments were conducted 1 week and 1 day before the start of the treatment programme. Post-treatment assessments were conducted immediately following the intensive component of the programme, and 3 months, 12 months and 3.5-5 years post-treatment. The student clinic treatment model in this report produced objective speech data for more subjects in one outcome study than has ever been reported before. Data for 87% (68/78) of participants were available at 3.5-5-year follow-up. Results showed that outcomes for stuttering, speech naturalness, and client self-reports were all comparable with existing reports of similar programmes. The present results were attained with a student/supervisor ratio of around 8:1. We conclude that a clinician-supervised student clinic has the potential to supply services for those with chronic stuttering, as well as providing effective clinical education for student clinicians during their professional preparation. The student clinic treatment model produced varied, objective speech data for more subjects than has ever been reported before in one study. The

  5. Outcome following treatment of feline gastrointestinal mast cell tumours.

    PubMed

    Barrett, L E; Skorupski, K; Brown, D C; Weinstein, N; Clifford, C; Szivek, A; Haney, S; Kraiza, S; Krick, E L

    2017-05-31

    Prognosis of feline gastrointestinal mast cell tumours (FGIMCT), based on limited available literature, is described as guarded to poor, which may influence treatment recommendations and patient outcome. The purpose of this study is to describe the clinical findings, treatment response, and outcome of FGIMCT. Medical records of 31 cats diagnosed with and treated for FGIMCT were retrospectively reviewed. Data collected included signalment, method of diagnosis, tumour location (including metastatic sites), treatment type, cause of death and survival time. Mean age was 12.9 y. Diagnosis was made via cytology (n = 15), histopathology (n = 13) or both (n = 3). Metastatic sites included abdominal lymph node (n = 10), abdominal viscera (n = 4) and both (n = 2). Therapeutic approaches included chemotherapy alone (n = 15), surgery and chemotherapy (n = 7), glucocorticoid only (n = 6) and surgery and glucocorticoid (n = 3). Lomustine (n = 15) and chlorambucil (n = 12) were the most commonly used chemotherapy drugs. Overall median survival time was 531 d (95% confidence interval 334, 982). Gastrointestinal location, diagnosis of additional cancers, and treatment type did not significantly affect survival time. Cause of death was tumour-related or unknown (n = 12) and unrelated (n = 8) in the 20 cats dead at the time of analysis. The prognosis for cats with FGIMCT may be better than previously reported, with 26% of cats deceased from an unrelated cause. Surgical and medical treatments (including prednisolone alone) were both associated with prolonged survival times. Treatment other than prednisolone may not be necessary in some cats. Continued research into prognostic factors and most effective treatment strategies are needed. © 2017 John Wiley & Sons Ltd.

  6. Smoking Outcome by Psychiatric History after Behavioral and Varenicline Treatment

    PubMed Central

    McClure, Jennifer B.; Swan, Gary E.; Catz, Sheryl L.; Jack, Lisa; Javitz, Harold; McAfee, Tim; Deprey, Mona; Richards, Julie; Zbikowski, Susan M.

    2010-01-01

    Treatment outcomes were compared across smokers enrolled in the COMPASS cessation trial with (PH+, n = 271) and without (PH-, n = 271) a diagnosis of psychiatric history based on medical record evidence of anxiety, depression, psychotic disorder, or bipolar disorder Everyone received behavioral counseling plus varenicline and was followed for 6 months post-quit date. PH+ smokers took varenicline for fewer days on average (59.4 vs. 68.5, P ≤ .01), but did not differ in their use of behavioral treatment. PH+ smokers were more likely to report anxiety and depression, but side-effect intensity ratings did not differ after adjusting for multiple comparisons. Overall, all side-effects were rated as moderate intensity or less. Groups had similar 30 day abstinence rates at 6 months (31.5% PH+ vs. 35.4% PH-, P = .35). In sum, having a psychiatric diagnosis in this trial did not predict worse treatment outcome or worse treatment side-effects. PMID:20363092

  7. Smoking outcome by psychiatric history after behavioral and varenicline treatment.

    PubMed

    McClure, Jennifer B; Swan, Gary E; Catz, Sheryl L; Jack, Lisa; Javitz, Harold; McAfee, Tim; Deprey, Mona; Richards, Julie; Zbikowski, Susan M

    2010-06-01

    Treatment outcomes were compared across smokers enrolled in the COMPASS cessation trial with (positive psychiatric history [PH+], n = 271) and without (PH-, n = 271) a diagnosis of PH based on medical record evidence of anxiety, depression, psychotic disorder, or bipolar disorder. Everyone received behavioral counseling plus varenicline and was followed for 6 months post quit date. PH+ smokers took varenicline for fewer days on average (59.4 vs. 68.5, p < or = .01) but did not differ in their use of behavioral treatment. PH+ smokers were more likely to report anxiety and depression, but side-effect intensity ratings did not differ after adjusting for multiple comparisons. Overall, all side effects were rated as moderate intensity or less. Groups had similar 30-day abstinence rates at 6 months (31.5% PH+ vs. 35.4% PH-, p = .35). In sum, having a psychiatric diagnosis in this trial did not predict worse treatment outcome or worse treatment side effects. Copyright 2010 Elsevier Inc. All rights reserved.

  8. Predicting Social Anxiety Treatment Outcome Based on Therapeutic Email Conversations.

    PubMed

    Hoogendoorn, Mark; Berger, Thomas; Schulz, Ava; Stolz, Timo; Szolovits, Peter

    2017-09-01

    Predicting therapeutic outcome in the mental health domain is of utmost importance to enable therapists to provide the most effective treatment to a patient. Using information from the writings of a patient can potentially be a valuable source of information, especially now that more and more treatments involve computer-based exercises or electronic conversations between patient and therapist. In this paper, we study predictive modeling using writings of patients under treatment for a social anxiety disorder. We extract a wealth of information from the text written by patients including their usage of words, the topics they talk about, the sentiment of the messages, and the style of writing. In addition, we study trends over time with respect to those measures. We then apply machine learning algorithms to generate the predictive models. Based on a dataset of 69 patients, we are able to show that we can predict therapy outcome with an area under the curve of 0.83 halfway through the therapy and with a precision of 0.78 when using the full data (i.e., the entire treatment period). Due to the limited number of participants, it is hard to generalize the results, but they do show great potential in this type of information.

  9. The impact of global budgeting on treatment intensity and outcomes.

    PubMed

    Kan, Kamhon; Li, Shu-Fen; Tsai, Wei-Der

    2014-12-01

    This paper investigates the effects of global budgets on the amount of resources devoted to cardio-cerebrovascular disease patients by hospitals of different ownership types and these patients' outcomes. Theoretical models predict that hospitals have financial incentives to increase the quantity of treatments applied to patients. This is especially true for for-profit hospitals. If that's the case, it is important to examine whether the increase in treatment quantity is translated into better treatment outcomes. Our analyses take advantage of the National Health Insurance of Taiwan's implementation of global budgets for hospitals in 2002. Our data come from the National Health Insurance's claim records, covering the universe of hospitalized patients suffering acute myocardial infarction, ischemic heart disease, hemorrhagic stroke, and ischemic stroke. Regression analyses are carried out separately for government, private not-for-profit and for-profit hospitals. We find that for-profit hospitals and private not-for-profit hospitals did increase their treatment intensity for cardio-cerebrovascular disease patients after the 2002 implementation of global budgets. However, this was not accompanied by an improvement in these patients' mortality rates. This reveals a waste of medical resources and implies that aggregate expenditure caps should be supplemented by other designs to prevent resources misallocation.

  10. Reproductive Outcome Following Hysteroscopic Treatment of Uterine Septum

    PubMed Central

    Esmaeilzadeh, Seddigheh; Delavar, Mouloud Agajani; Andarieh, Maryam Ghanbari

    2014-01-01

    Background: Septate uterus is the most common uterine anomaly and a cause for miscarriage and infertility. Existing data suggested a better reproductive outcome of uterine septum following hysteroscopic septum resection. Objective: Current study was administered to share our experience in hystroscopic septum resection for reproductive outcome following hysteroscopic treatment of uterine septum and specifically focusing on different treatment protocols after hysteroscopic septum resection. Methods& materials: This study was a cross-sectional study based on secondary data that was obtained from medical records of infertile women who had undergone transvaginal hysteroscopy and used different treatment protocols after hysteroscopic correction of uterine septum in Infertility and Reproductive Health Research Center between April 2005 and February 2014. Results: The total number of infertile women underwent hysteroscopy uterine septoplasty was 106. The hysteroscopy septoplasty resulted in an overall pregnancy rate of 67% and a live birth 57.5%. Pregnancy rate for patients who had not male infertility was 92.1%. The chi-square test did not reveal any statistically significant difference in side affect, pregnancy, live birth, abortion, preterm deliveries, and term deliveries rate between these patients either with consistent hormone therapy plus IUD insertion or with alternate hormone therapy plus IUD after hysteroscopic metroplasty. Conclusion: The findings of the present study indicated hysteroscopic septum resection to remove a uterine septum in women with infertility is safe and may be an efficacious procedure. Treatment following hysteroscopic septum resection, either the consistent or the alternate protocol is both beneficial to improve pregnancy rate. PMID:25685079

  11. Similarity of Outcome Predictors across Opiate, Cocaine, and Alcohol Treatments: Role of Treatment Services.

    ERIC Educational Resources Information Center

    McLellan, A. Thomas; And Others

    1994-01-01

    Outcomes were predicted by similar factors, regardless of drug problem or type of treatment. Greater substance use at follow-up was predicted by greater severity of use at admission, not number of services during treatment. Social adjustment was negatively predicted by more severe psychiatric problems at admission and positively predicted by more…

  12. Effects of Comorbidity on Treatment Processes and Outcomes among Adolescents in Drug Treatment Programs

    ERIC Educational Resources Information Center

    Grella, Christine E.; Joshi, Vandana; Hser, Yih-Ing

    2004-01-01

    This study examined the relationship between treatment processes and posttreatment abstinence using data from the Drug Abuse Treatment Outcomes Studies for Adolescents (N = 810), with a focus on differences between adolescents with and without a comorbid mental disorder. The majority of the sample (62%) was diagnosed with at least one co-occurring…

  13. The Antidepressant Treatment Response Index as a Predictor of Reboxetine Treatment Outcome in Major Depressive Disorder.

    PubMed

    Caudill, Marissa M; Hunter, Aimee M; Cook, Ian A; Leuchter, Andrew F

    2015-10-01

    Biomarkers to predict clinical outcomes early during the treatment of major depressive disorder (MDD) could reduce suffering and improve outcomes. A quantitative electroencephalogram (qEEG) biomarker, the Antidepressant Treatment Response (ATR) index, has been associated with outcomes of treatment with selective serotonin reuptake inhibitor antidepressants in patients with MDD. Here, we report the results of a post hoc analysis initiated to evaluate whether the ATR index may also be associated with reboxetine treatment outcome, given that its putative mechanism of action is via norepinephrine reuptake inhibition (NRI). Twenty-five adults with MDD underwent qEEG studies during open-label treatment with reboxetine at doses of 8 to 10 mg daily for 8 weeks. The ATR index calculated after 1 week of reboxetine treatment was significantly associated with overall Hamilton Depression Rating Scale (HAM-D) improvement at week 8 (r=0.605, P=.001), even after controlling for baseline depression severity (P=.002). The ATR index predicted response (≥50% reduction in HAM-D) with 70.6% sensitivity and 87.5% specificity, and remission (final HAM-D≤7) with 87.5% sensitivity and 64.7% specificity. These results suggest that the ATR index may be a useful biomarker of clinical response during NRI treatment of adults with MDD. Future studies are warranted to investigate further the potential utility of the ATR index as a predictor of noradrenergic antidepressant treatment response.

  14. Effects of Comorbidity on Treatment Processes and Outcomes among Adolescents in Drug Treatment Programs

    ERIC Educational Resources Information Center

    Grella, Christine E.; Joshi, Vandana; Hser, Yih-Ing

    2004-01-01

    This study examined the relationship between treatment processes and posttreatment abstinence using data from the Drug Abuse Treatment Outcomes Studies for Adolescents (N = 810), with a focus on differences between adolescents with and without a comorbid mental disorder. The majority of the sample (62%) was diagnosed with at least one co-occurring…

  15. The Effects of Drinking Goal on Treatment Outcome for Alcoholism

    PubMed Central

    Bujarski, Spencer; O'Malley, Stephanie S.; Lunny, Katy; Ray, Lara A.

    2014-01-01

    Objective It is well known to clinicians and researchers in the field of alcoholism that patients vary with respect to drinking goal. The objective of this study is to elucidate the contribution of drinking goal to treatment outcome in the context of specific behavioral and pharmacological interventions. Method Participants were 1226 alcohol dependent individuals enrolled in a large, multi-site trial of Combined Behavioral Intervention (CBI), acamprosate, and naltrexone. Drinking goal was coded as follows: (a) controlled drinking, (b) conditional abstinence, and (c) complete abstinence. Results Analysis revealed a main effect of drinking goal on percent days abstinent (p < .0001), days to relapse to heavy drinking (p < 0.0001), and global clinical outcome (p < .001). These results were such that a goal of complete abstinence was associated with the best outcomes, followed by conditional abstinence; controlled drinking was associated with the poorest outcomes. Conversely, a main effect of drinking goal was observed on drinks per drinking day (p < .01), such that controlled drinking was associated with fewer drinks per drinking day whereas complete abstinence was associated with the highest drinks per drinking day. CBI performed better than medical management alone for participants whose drinking goal was not complete abstinence. Conclusion These results suggest that drinking goal represents a highly predictive clinical variable and should be an integral part of the clinical assessment of patients with alcohol dependence. Assessment of patients' drinking goals may also help match patients to interventions best suited to address their goals and clinical needs. PMID:23231573

  16. Temporal bone verrucous carcinoma: outcomes and treatment controversy

    PubMed Central

    Martin, Neil; Juillard, Guy F.; Bhuta, Sunita; Ishiyama, Akira

    2010-01-01

    Verrucous carcinoma is a rare tumor that presents in the head and neck with the most common sites being the oral cavity and larynx. Fourteen cases of verrucous carcinoma of the temporal bone have been described in literature; this study aims to examine treatment outcomes and discuss the controversy surrounding postoperative radiation. The study design included a literature review along with individual case report in the setting of a tertiary care medical center. Outcome analysis of all cases of verrucous carcinoma of the temporal bone, which are documented in the English literature, and presentation of a single patient report including gross, histologic and radiologic analyses were performed. The longest recorded survival for verrucous carcinoma of the temporal bone occurs in patients treated with surgery alone. Poorer outcomes for patients treated with adjuvant (chemo)radiation may be due to more advanced stage of disease at the time of treatment. Early reports of radiation leading to tumor dedifferentiation or early recurrence are not supported by more recent studies. Whether adjuvant radiation therapy is indicated in verrucous carcinoma of the temporal bone remains controversial. PMID:20502907

  17. Infertility treatment outcome in sub groups of obese population

    PubMed Central

    Awartani, Khalid A; Nahas, Samar; Al Hassan, Saad H; Al Deery, Mashael A; Coskun, Serdar

    2009-01-01

    Background Obesity is a common disorder with a negative impact on IVF treatment outcome. It is not clear whether morbidly obese women (BMI >= 35 kg/m2) respond to treatment differently as compared to obese women (BMI = 30–34.9 kg/m2) in IVF. Our aim was to compare the outcome of IVF or ICSI treatments in obese patients to that in morbidly obese patients. Methods This retrospective cohort study was conducted in a tertiary care centre. Patients inclusion criteria were as follows; BMI ≥ 30, age 20–40 years old, first cycle IVF/ICSI treatment with primary infertility and long follicular pituitary down regulation protocol. Results A total of 406 obese patients (group A) and 141 morbidly obese patients (group B) satisfied the inclusion criteria. Average BMI was 32.1 ± 1.38 kg/m2 for group A versus 37.7 ± 2.99 kg/m2 for group B. Patient age, cause of infertility, duration of stimulation, fertilization rate, and number of transferred embryos were similar in both groups. Compared to group A, group B had fewer medium size and mature follicles (14 vs. 16), fewer oocytes collected (7 vs. 9) and required higher doses of HMG (46.2 vs. 38.5 amps). There was also a higher cancellation rate in group B (28.3% vs. 19%) and lower clinical pregnancy rate per started cycle (19.9% vs. 28.6%). Conclusion In a homogenous infertile and obese patient population stratified according to their BMI, morbid obesity is associated with unfavorable IVF/ICSI cycle outcome as evidenced by lower pregnancy rates. It is recommended that morbidly obese patients undergo appropriate counseling before the initiation of this expensive and invasive therapy. PMID:19473499

  18. Cognitive behavior therapy with Internet addicts: treatment outcomes and implications.

    PubMed

    Young, Kimberly S

    2007-10-01

    Research over the last decade has identified Internet addiction as a new and often unrecognized clinical disorder that impact a user's ability to control online use to the extent that it can cause relational, occupational, and social problems. While much of the literature explores the psychological and social factors underlying Internet addiction, little if any empirical evidence exists that examines specific treatment outcomes to deal with this new client population. Researchers have suggested using cognitive behavioral therapy (CBT) as the treatment of choice for Internet addiction, and addiction recovery in general has utilized CBT as part of treatment planning. To investigate the efficacy of using CBT with Internet addicts, this study investigated 114 clients who suffered from Internet addiction and received CBT at the Center for Online Addiction. This study employed a survey research design, and outcome variables such as client motivation, online time management, improved social relationships, improved sexual functioning, engagement in offline activities, and ability to abstain from problematic applications were evaluated on the 3rd, 8th, and 12th sessions and over a 6-month follow-up. Results suggested that Caucasian, middle-aged males with at least a 4-year degree were most likely to suffer from some form of Internet addiction. Preliminary analyses indicated that most clients were able to manage their presenting complaints by the eighth session, and symptom management was sustained upon a 6-month follow-up. As the field of Internet addiction continues to grow, such outcome data will be useful in treatment planning with evidenced-based protocols unique to this emergent client population.

  19. Robust feature selection to predict tumor treatment outcome.

    PubMed

    Mi, Hongmei; Petitjean, Caroline; Dubray, Bernard; Vera, Pierre; Ruan, Su

    2015-07-01

    Recurrence of cancer after treatment increases the risk of death. The ability to predict the treatment outcome can help to design the treatment planning and can thus be beneficial to the patient. We aim to select predictive features from clinical and PET (positron emission tomography) based features, in order to provide doctors with informative factors so as to anticipate the outcome of the patient treatment. In order to overcome the small sample size problem of datasets usually met in the medical domain, we propose a novel wrapper feature selection algorithm, named HFS (hierarchical forward selection), which searches forward in a hierarchical feature subset space. Feature subsets are iteratively evaluated with the prediction performance using SVM (support vector machine). All feature subsets performing better than those at the preceding iteration are retained. Moreover, as SUV (standardized uptake value) based features have been recognized as significant predictive factors for a patient outcome, we propose to incorporate this prior knowledge into the selection procedure to improve its robustness and reduce its computational cost. Two real-world datasets from cancer patients are included in the evaluation. We extract dozens of clinical and PET-based features to characterize the patient's state, including SUV parameters and texture features. We use leave-one-out cross-validation to evaluate the prediction performance, in terms of prediction accuracy and robustness. Using SVM as the classifier, our HFS method produces accuracy values of 100% and 94% on the two datasets, respectively, and robustness values of 89% and 96%. Without accuracy loss, the prior-based version (pHFS) improves the robustness up to 100% and 98% on the two datasets, respectively. Compared with other feature selection methods, the proposed HFS and pHFS provide the most promising results. For our HFS method, we have empirically shown that the addition of prior knowledge improves the robustness and

  20. Treatment outcomes of chemical castration on Korean sex offenders.

    PubMed

    Koo, Kyo Chul; Shim, Geum Sook; Park, Hyoun Hee; Rha, Koon Ho; Choi, Young Deuk; Chung, Byung Ha; Hong, Sung Joon; Lee, Jae Woo

    2013-08-01

    After the recent enactment of the chemical castration legislation for sex offenders in Korea, we sought to report primary treatment outcomes for 38 patients at the National Forensic Hospital since 2011. After chemical castration, these patients experienced reductions in frequency and intensity of sexual drive, frequency of masturbation and sexual fantasies. The incidence of adverse effects was similar to that of previous reports. Serial hormonal evaluations showed an association between testosterone level and degree of paraphilic and non-paraphilic sexual thoughts. A notable finding was an unexpected upsurge of testosterone levels with intense sexual drive and fantasy observed during the first 2 months after cessation of treatment. This suggested the need for a temporary anti-androgen therapy or close surveillance during this period. When proper precautions are taken, chemical castration may be an effective treatment strategy for paraphilic and non-paraphilic sex offenders. Copyright © 2013 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

  1. Strategies for managing aortoiliac occlusions: access, treatment and outcomes

    PubMed Central

    Clair, Daniel G; Beach, Jocelyn M

    2015-01-01

    Treatment of severe aortoiliac disease has dramatically evolved from a dependence on open aortobifemoral grafting to hybrid and endovascular only approaches. Open surgery has been the gold standard treatment of severe aortoiliac disease with excellent patency rates, but with increased length of stay and major complications. In contrast, endovascular interventions can successfully treat almost any lesion with decreased risk, compared to open surgery. Although primary patency rates remain inferior, secondary endovascular interventions are often minor procedures resulting in comparable long-term outcomes. The risks of renal insufficiency, embolization and access complications are not insignificant; however, most can be prevented or managed without significant clinical consequence. Endovascular therapies should be considered a first-line treatment option for all patients with aortoiliac disease, especially those with high-risk cardiovascular comorbidities. PMID:25907618

  2. Effect of Low-Magnitude Whole-Body Vibration Combined with Alendronate in Ovariectomized Rats: A Random Controlled Osteoporosis Prevention Study

    PubMed Central

    Zhong, Zhao-Ming; Wu, Xiu-Hua; Huang, Zhi-Ping; Li, Wei; Ding, Ruo-Ting; Yu, Hui; Chen, Jian-Ting

    2014-01-01

    Background Alendronate (ALE) is a conventional drug used to treat osteoporosis. Low-magnitude whole-body vibration (WBV) exercise has been developed as a potential treatment for osteoporosis. The aim of this study was to investigate whether low-magnitude WBV could enhance the protective effect of ALE on bone properties in ovariectomized rats. Methods A total of 128 Sprague-Dawley rats were randomly divided into five groups (SHAM, OVX+VEH, OVX+WBV, OVX + ALE, OVX+WBV+ALE). The level of WBV applied was 0.3 g at 45–55 Hz for 20 min/day, 5 day/week and for 3 months. ALE was administered in dose of 1 mg/Kg once a week. Every four weeks eight rats from each group were sacrificed and their blood and both tibiae were harvested. The expression of osteocalcin and CTX in serum was measured by enzyme-linked immunosorbent assay (ELISA) and the tibiae were subjected to metaphyseal three-point bending and μCT analysis. Results Osteocalcin rose after ovariectomy and was not appreciably changed by either alendronate or WBV alone or in combination. Alendronate treatment significantly prevented an increase in CTX. WBV alone treatment did not alter this effect. Compared with the OVX+WBV group, nearly all tested indices such as the BV/TV, TV apparent, Tb.N, Tb.Th, and Conn.D were higher in the OVX+ALE group at week 12.Compared with the OVX+WBV group, certain tested indices such as BV/TV, TV apparent, Tb.N, and Con.D, were higher in the OVX+WBV+ALE group at week 12. At week 12, tibiae treated with WBV+ALE exhibited a significantly higher Fmax compared to the OVX+VEH group, and a significant difference was also found in energy absorption between the OVX+WBV+ALE and OVX+VEH groups. Conclusions Compared with the WBV, ALE was more effective at preventing bone loss and improved the trabecular architecture. However, WBV enhanced the effect of alendronate in ovariectomized rats by inducing further improvements in trabecular architecture. PMID:24796785

  3. Traumatized refugees: morbidity, treatment and predictors of outcome.

    PubMed

    Buhmann, Caecilie Böck

    2014-08-01

    Despite large numbers of traumatized refugees, little is known about effective treatment of war trauma in refugees and immigrants. Few studies evaluating treatment have been published and most studies are follow-up studies with methodological limitations and little comparability across studies. The purpose of the PhD is to characterize transcultural trauma patients in Denmark needing psychiatric treatment with regards to psychopathology and predictors of mental health and to evaluate the effects of the treatment. Two studies reported in 4 papers form the basis of the thesis. FORLOB (Paper 1-3) was a follow-up study that included all patients receiving treatment at the Competence Center for Transcultural Psychiatry in Copenhagen from April 2008 to February 2010. Patients completed self-ratings of symptoms of PTSD, depression and anxiety as well as level of functioning and quality of life (HTQ, HSCL-25, SDS & WHO-5) before treatment and after treatment. Associations of co-morbid diagnoses and predictors of the patients' health condition were examined with linear and logistic regression and Pearson's correlation coefficients. Treatment in FORLOB consisted of a combination of Sertraline, Mianserin, psycho-education and Trauma-Focused Cognitive Behavioral Therapy (TFCBT). The treatment administered to each patient was monitored in detail and changes in outcome and predictors of change were analyzed. PTF1 (Paper 4) was a randomized controlled clinical trial with 2x2 factorial design (antidepressants, TFCBT, antidepressants & TFCBT, waiting list). Potential participants were screened amongst adult patients referred to the Competence Center for Transcultural Psychiatry in the period June 2009-2011. Patients with PTSD, war trauma and without a psychotic disorder were included. The manualized treatment consisted of weekly sessions with a physician and/or psychologist over a period of 6 months. The treatment effect was evaluated with a combination of self-ratings and blinded

  4. Factors related to treatment and outcomes of avulsed teeth.

    PubMed

    Petrovic, Bojan; Marković, Dejan; Peric, Tamara; Blagojevic, Duska

    2010-02-01

    The aim of this study was to examine factors associated with avulsion injury and to specify the association between these factors and the treatment, as well as the outcomes of avulsed permanent incisors in children. The sample consisted of 51 children with 62 avulsed permanent incisors, whose injuries had been managed in the period 1998-2006. The study was prospective, recording the history of the accident, concomitant injuries, age, gender, apical maturity of the root, replantation rate, storage media, extra-alveolar duration, endodontic treatment, compliance and recall appointments response. Factors were analysed in relation to postoperative outcomes, classified as functional healing (FH), infection-related (inflammatory) resorption (IRR) and replacement resorption (RR). The average age of patients was 10.7 years (range 7-19). In 16/51 patients, tooth avulsion was caused by a road traffic accident. Avulsion was accompanied by concomitant injuries in all cases. Thirty of 62 avulsed teeth were not replanted and 32 incisors were replanted after dry storage. Time until replantation ranged between 15 min and 9 h (median 60 min). The observation period ranged from 1 to 6 years (median 2 years). FH was observed in 5/32, IRR in 20/32 and RR in 7/32 incisors. Ten teeth were extracted during 5-years of observation. Immature incisors exhibited significantly more complications compared with mature teeth (P = 0.04). Storage media and extra-alveolar duration did not significantly affect the survival of replanted teeth (P = 0.253, P = 0.350). Teeth in which endodontic treatment was in temporary phase exhibited significantly more complications in comparison with teeth with completed endodontic treatment (P = 0.0l6). The combination of delayed replantation and unphysiological storage is followed by low survival. Incisors with open apices exhibited lower survival compared with incisors with closed apices. Replanted incisors that required prolonged treatment with calcium hydroxide

  5. Clubfoot: the treatment outcome using quantitative assessment of deformity.

    PubMed

    Rasit, Ah; Rasit, Ah; Azani, H; Zabidah, Pa; Merikan, A; Nur Alyana, Ba

    2012-06-01

    The recent trend in management of congenital idiopathic clubfoot tends towards conservative treatment. This study reviews the outcomes of treatment in our practice using the quantitative clubfoot assessment of the deformity (QCAD). Thirty patients (38 cases of clubfoot) with congenital idiopathic clubfoot treated at Sarawak General Hospital were followed-up for a mean of 3.6 years. The quantitative assessment consists of limb anthropometric measurement and the Pirani deformity severity score. There were 15 boys and 15 girls, with a mean age of 4.4 years (range, 13m - 8y). Most patients were of the Malay race (67%), followed by Chinese (23%) and others (10%). Eight patients suffered from bilateral congenital idiopathic clubfoot (33%), 12 were left unilateral (40%) and 10 were right unilateral (27%). Out of the total of 30 patients, 12 were treated conservatively with serial casting and 18 patients were treated surgically after resistance to serial casting at the age of nine months. At follow-up, there were significant differences between the surgical group (2.57 ± 1.45); (0.86 ± 0.36) and conservative group (0.7 ± 0.81); (0.34 ± 0.35) respectively (p < 0.05) regarding the mean difference in mid-leg circumference and foot length discrepancy in patients with unilateral clubfoot. There were no significant difference noted between groups with regards to results of the Pirani score, leg length discrepancy and mean difference of mid-foot circumference. There were significant differences in calf atrophy and foot length discrepancy when comparing surgically treated clubfoot patient compared to conservatively treated patients. Conservative treatment of clubfoot is the preferred method of treatment while surgical treatment may be necessary in more resistant cases. Clubfoot, outcome, treatment, quantitative assessment, deformity.

  6. Inherited and acquired thrombophilia: pregnancy outcome and treatment.

    PubMed

    De Santis, Marco; Cavaliere, A F; Straface, G; Di Gianantonio, E; Caruso, A

    2006-08-01

    Maternal thrombophilias increases the risk of an adverse pregnancy outcome. An extensive literature review highlights the role of inherited and acquired thrombophilic disorders in spontaneous abortion, both early and late, recurrent or isolate, in intrauterine growth retardation, in placenta abruption, in pre-eclampsia and in venous thromboembolism. We have particularly focused attention on the following factors: antithrombin III (ATIII), proteins C (PC) and S (PS) deficiencies, genetic mutations particularly factor V Leiden (FVL), prothrombin gene G20210A (PTM) and the thermolabile variant of the methylene tetrahydrofolate reductase C677T (MTHFR) gene, lupus anticoagulant (LAC) and anticardiolipin antibodies, VIIIc factor, hyperhomocysteinemia and acquired activated protein C resistance. Appropriate treatment can improve pregnancy outcome without teratogenic effects.

  7. Compensation and treatment: disability benefits and outcomes of U.S. veterans receiving residential PTSD treatment.

    PubMed

    Belsher, Bradley E; Tiet, Quyen Q; Garvert, Donn W; Rosen, Craig S

    2012-10-01

    The U.S. Department of Veterans Affairs (VA) provides specialized intensive posttraumatic stress disorder (PTSD) programs to treat trauma-related symptoms in addition to providing service-connected disability to compensate veterans for injury sustained while serving in the military. Given the percentage of veterans who are receiving treatment for PTSD, in addition to seeking compensation for PTSD, a debate has emerged about the impact of compensation on symptom recovery. This study examined the associations among status of compensation, treatment expectations, military cohort, length of stay, and outcomes for 776 veterans who were enrolled in 5 VA residential PTSD programs between the years of 2005 and 2010. Mixed model longitudinal analyses, with age, gender, and baseline symptoms nested within treatment site in the model, found that treatment expectations were modestly predictive of treatment outcomes. Veterans seeking increased compensation reported marginally lower treatment expectations (d = .008), and did not experience poorer outcomes compared to veterans not seeking increased compensation with the effect of baseline symptoms partialled out. Veterans from the era of the Iraq and Afghanistan conflicts reported lower treatment expectations (d = .020) and slightly higher symptoms at intake (d = .021), but had outcomes at discharge equivalent to veterans from other eras with baseline symptoms partialled out. These findings help further inform the debate concerning disability benefits and symptom changes across time. Published 2012. This article is a US Government work and is in the public domain in the USA.

  8. Treatment outcome of tuberculosis patients under directly observed treatment in Addis Ababa, Ethiopia.

    PubMed

    Getahun, Belete; Ameni, Gobena; Medhin, Girmay; Biadgilign, Sibhatu

    2013-01-01

    Tuberculosis is one of the leading causes of mortality among infectious diseases worldwide. For effective tuberculosis control, it is a pre-requisite to detect the cases as early as possible, and to ensure that the tuberculosis patients complete their treatment and get cured. However, in many resource-constrained settings treatment outcome for tuberculosis has not been satisfactory. The aim of the study was to assess the treatment outcome of tuberculosis patients and investigate the association of demographic and clinical factors with treatment success of patients enrolled in Directly Observed Treatment Short Course program in government owned health centers over the course of five consecutive years in Addis Ababa, Ethiopia. A register based historical cohort study covering the period of July 2004 to June 2009 was conducted to determine the treatment outcome of Directly Observed Treatment Short Course in government owned health centers in Addis Ababa. Sex and age of tuberculosis patients, health center at which the patient was treated, year of treatment, type of tuberculosis for which the patient was treated, type of treatment offered to the patient, follow-up status and documented treatment outcome were extracted from the Directly Observed Treatment Short Course clinics of three randomly selected health centers. Records of 6450 registered tuberculosis patients (n=3147 males and 3433 females) were included in this document review. Of these patients 18.1% were reported as being cured, 64.6% were documented as treatment completed, 3.7% died during follow-up, 5.1% were reported as defaulters, 0.4% were documented as treatment failure and 8.2% were transferred out to another health institution. Treatment center and year of enrollment were significantly associated with treatment success. Year of enrollment and treatment center were significantly associated with treatment success. Although the overall treatment success obtained in this study is in line with the World

  9. Effect of Alendronate on Bone Formation during Tooth Extraction Wound Healing

    PubMed Central

    Tanoue, R.; Koi, K.

    2015-01-01

    Alendronate (ALN) is an antiresorptive agent widely used for the treatment of osteoporosis. Its suppressive effect on osteoclasts has been extensively studied. However, the effect of ALN on bone formation is not as clear as its effect on resorption. The objective was to determine the effect of short-term ALN on bone formation and tooth extraction wound healing. Molar tooth extractions were performed in mice. ALN, parathyroid hormone (PTH), or saline (vehicle control) was administered. PTH was used as the bone anabolic control. Mice were euthanized at 3, 5, 7, 10, and 21 d after extractions. Hard tissue healing was determined histomorphometrically. Neutrophils and lymphatic and blood vessels were quantified to evaluate soft tissue healing. Gene expression in the wounds was assessed at the RNA level. Furthermore, the vossicle bone transplant system was used to verify findings from extraction wound analysis. Alkaline phosphatase (ALP) was visualized in the vossicles to assess osteoblast activity. ALN exhibited no negative effect on bone formation. In intact tibiae, ALN increased bone mass significantly more than PTH did. Consistently, significantly elevated osteoblast numbers were noted. In the extraction sockets, bone fill in the ALN-treated mice was equivalent to the control. Genes associated with bone morphogenetic protein signaling, such as bmp2, nog, and dlx5, were activated in the extraction wounds of the ALN-treated animals. Bone formation in vossicles was significantly enhanced in the ALN versus PTH group. In agreement with this, ALN upregulated ALP activity considerably in vossicles. Neutrophil aggregation and suppressed lymphangiogenesis were evident in the soft tissue at 21 d after extraction, although gross healing of extraction wounds was uneventful. Bone formation was not impeded by short-term ALN treatment. Rather, short-term ALN treatment enhanced bone formation. ALN did not alter bone fill in extraction sockets. PMID:26124220

  10. Effect of Alendronate on Bone Formation during Tooth Extraction Wound Healing.

    PubMed

    Tanoue, R; Koi, K; Yamashita, J

    2015-09-01

    Alendronate (ALN) is an antiresorptive agent widely used for the treatment of osteoporosis. Its suppressive effect on osteoclasts has been extensively studied. However, the effect of ALN on bone formation is not as clear as its effect on resorption. The objective was to determine the effect of short-term ALN on bone formation and tooth extraction wound healing. Molar tooth extractions were performed in mice. ALN, parathyroid hormone (PTH), or saline (vehicle control) was administered. PTH was used as the bone anabolic control. Mice were euthanized at 3, 5, 7, 10, and 21 d after extractions. Hard tissue healing was determined histomorphometrically. Neutrophils and lymphatic and blood vessels were quantified to evaluate soft tissue healing. Gene expression in the wounds was assessed at the RNA level. Furthermore, the vossicle bone transplant system was used to verify findings from extraction wound analysis. Alkaline phosphatase (ALP) was visualized in the vossicles to assess osteoblast activity. ALN exhibited no negative effect on bone formation. In intact tibiae, ALN increased bone mass significantly more than PTH did. Consistently, significantly elevated osteoblast numbers were noted. In the extraction sockets, bone fill in the ALN-treated mice was equivalent to the control. Genes associated with bone morphogenetic protein signaling, such as bmp2, nog, and dlx5, were activated in the extraction wounds of the ALN-treated animals. Bone formation in vossicles was significantly enhanced in the ALN versus PTH group. In agreement with this, ALN upregulated ALP activity considerably in vossicles. Neutrophil aggregation and suppressed lymphangiogenesis were evident in the soft tissue at 21 d after extraction, although gross healing of extraction wounds was uneventful. Bone formation was not impeded by short-term ALN treatment. Rather, short-term ALN treatment enhanced bone formation. ALN did not alter bone fill in extraction sockets.

  11. Functional network connectivity predicts treatment outcome during treatment of nicotine use disorder.

    PubMed

    Wilcox, Claire E; Calhoun, Vince D; Rachakonda, Srinivas; Claus, Eric D; Littlewood, Rae A; Mickey, Jessica; Arenella, Pamela B; Hutchison, Kent E

    2017-07-30

    Altered resting state functional connectivity (rsFC) and functional network connectivity (FNC), which is a measure of coherence between brain networks, may be associated with nicotine use disorder (NUD). We hypothesized that higher connectivity between insula and 1) dorsal anterior cingulate cortex (dACC) and 2) dorsolateral prefrontal cortex (dlPFC) would predict better treatment outcomes. We also performed an exploratory analysis of the associations between FNC values between additional key frontal and striatal regions and treatment outcomes. One hundred and forty four individuals with NUD underwent a resting state session during functional MRI prior to randomization to treatment with varenicline (n=82) or placebo. Group independent component analysis (ICA) was utilized to extract individual subject components and time series from intrinsic connectivity networks in aforementioned regions, and FNC between all possible pairs were calculated. Higher FNC between insula and dACC (rho=0.21) was significantly correlated with lower levels of baseline smoking quantity but did not predict treatment outcome upon controlling for baseline smoking. Higher FNC between putamen and dACC, caudate and dACC, and caudate and dlPFC significantly predicted worse treatment outcome in participants reporting high subjective withdrawal before the scan. FNC between key regions hold promise as biomarkers to predict outcome in NUD. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  12. Can anesthetic treatment worsen outcome in status epilepticus?

    PubMed

    Sutter, Raoul; Kaplan, Peter W

    2015-08-01

    Status epilepticus refractory to first-line and second-line antiepileptic treatments challenges neurologists and intensivists as mortality increases with treatment refractoriness and seizure duration. International guidelines advocate anesthetic drugs, such as continuously administered high-dose midazolam, propofol, and barbiturates, for the induction of therapeutic coma in patients with treatment-refractory status epilepticus. The seizure-suppressing effect of anesthetic drugs is believed to be so strong that some experts recommend using them after benzodiazepines have failed. Although the rationale for the use of anesthetic drugs in patients with treatment-refractory status epilepticus seems clear, the recommendation of their use in treating status epilepticus is based on expert opinions rather than on strong evidence. Randomized trials in this context are lacking, and recent studies provide disturbing results, as the administration of anesthetics was associated with poor outcome independent of possible confounders. This calls for caution in the straightforward use of anesthetics in treating status epilepticus. However, there are still more questions than answers, and current evidence for the adverse effects of anesthetic drugs in patients with status epilepticus remains too limited to advocate a change of treatment algorithms. In this overview, the rationale and the conflicting clinical implications of anesthetic drugs in patients with treatment-refractory status epilepticus are discussed, and remaining questions are elaborated. This article is part of a Special Issue entitled "Status Epilepticus". Copyright © 2015 Elsevier Inc. All rights reserved.

  13. Intralesional Bleomycin for Warts: Patient Satisfaction and Treatment Outcomes.

    PubMed

    Kruter, Laura; Saggar, Vishal; Akhavan, Alaleh; Patel, Parth; Umanoff, Nicole; Viola, Kate V; Stebbins, William; Smith, Elizabeth; Akhavan, Arash; Cohen, Justine V; Cohen, Steven R

    2015-01-01

    The treatment of warts is challenging with regards to both tolerability and efficacy. Ascertain the efficacy, tolerability, and patient satisfaction of intralesional bleomycin in the treatment of warts. Retrospective chart review followed by telephone interviews with patients from university-based dermatology referral centers. Seventy-four percent (34/46) of patients had complete resolution (CR) of all warts. Of 34 patients who experienced CR, an average of 1.7 treatments were required. Pain experienced during the procedure and recovery, irrespective of outcome, was rated 5.8 out of 10 (range, 1-10; SD, 2.72; SEM, 0.40). Approximately 70% of patients had pain that lasted less than 2 days after treatment. Seventy-eight percent (36/46) of patients in the study were satisfied with treatment and would recommend it to others. Patients felt bleomycin to be an effective treatment modality for warts, offering high rates of CR in lesions resistant to more traditional therapies. © The Author(s) 2015.

  14. Treatment outcomes of the intraoral approach for a simple ranula.

    PubMed

    Lee, Dong Hoon; Yoon, Tae Mi; Lee, Joon Kyoo; Lim, Sang Chul

    2015-04-01

    The study sought to determine the optimal surgical treatment of a simple ranula and analyzed the clinical characteristics and treatment outcomes of a simple ranula in our hospital. A retrospective review was performed to evaluate patients with a diagnosis of a simple ranula at Chonnam National University Hwasun Hospital from November 2007 to August 2013. Clinical data on simple ranulas that were reviewed included gender, age, symptoms, duration of symptoms, location and size of lesion, surgical procedures, complications, recurrence, and follow-up. The 24 patients included in the study comprised 10 males and 14 females. Sixteen patients (66.7%) did not have a prior treatment history. Eight patients had undergone previous treatment, which included Picibanil injection sclerotherapy, incision and drainage, and micromarsupialization. The simple ranula recurred after excision of the ranula and the sublingual gland in only one (4.2%) of 24 cases. In eight patients who had undergone previous treatment, there was no recurrence after excision of the ranula and sublingual gland. There were no major complications and recurrences in the patients with recurrent simple ranulas. Excision of the ranula and the sublingual gland via intraoral approach is the optimal treatment for a simple ranula, even in the case of a recurrent simple ranula. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. [Predictors of outcome of a smoking cessation treatment by gender].

    PubMed

    Marqueta, Adriana; Nerín, Isabel; Jiménez-Muro, Adriana; Gargallo, Pilar; Beamonte, Asunción

    2013-01-01

    To identify factors predictive of the outcome of a smoking cessation program by gender. A cross-sectional study of smokers starting treatment in a smoking cessation clinic from 2002 to 2007 was conducted. The variables consisted of data on sociodemographic factors, smoking habits, the social context of smoking and psychiatric comorbidity prior to or during the smoking cessation process. All patients received multicomponent treatment consisting of psychological and pharmacological interventions. Success was defined as self-reported continuous abstinence confirmed by cooximetry (CO ≤10 ppm). Logistic regression was used to analyze the factors predictive of success. A total of 1302 persons (52.1% men and 47.9% women), with a mean age of 43.4 (10.2) years, were included. The mean number of cigarettes smoked per day was 25.3 (10.4) and the mean Fagerström test score was 6.2 (2.2) points. The success rate was 41.3% (538) with no differences by gender. Positive predictors were lower nicotine dependence and having a non-smoking partner in men and older age, smoking fewer cigarettes per day, having fewer smoking friends and not experiencing depression or anxiety during the treatment in women. Men and women have similar tobacco abstinence outcomes although gender factors play a role in determining abstinence. The gender perspective should be incorporated in smoking prevention and cessation programs. Copyright © 2011 SESPAS. Published by Elsevier Espana. All rights reserved.

  16. Patient characteristics, treatment patterns, and health outcomes among COPD phenotypes

    PubMed Central

    Allen-Ramey, Felicia C; Gupta, Shaloo; DiBonaventura, Marco daCosta

    2012-01-01

    Background: Recent literature has suggested that emphysema and chronic bronchitis, traditionally considered to be entities overlapping within chronic obstructive pulmonary disease (COPD), may be distinct disorders. Few studies have examined the differences in patient characteristics and health outcomes between these conditions. This study examined whether COPD phenotypes represent distinct patient populations, in a large nationally representative US sample. Methods: Data were obtained from the 2010 US National Health and Wellness Survey (NHWS). NHWS respondents (n = 75,000) were categorized as a COPD phenotype based on their self-reported diagnosis of COPD only (n = 970), emphysema only (n = 399), or chronic bronchitis only (n = 2071). Phenotypes were compared on demographics, health characteristics, treatment patterns, health outcomes, work productivity, and resource use. Variables were compared using Chi-square and analysis of variance tests for categorical and continuous outcomes, respectively. Health outcomes were also examined using regression modeling, controlling for demographic and health characteristic covariates. Results: Patients with chronic bronchitis were significantly younger (51.38 years versus 63.24 years for COPD versus 63.30 years for emphysema, P < 0.05) and more likely to be employed (46.98% versus 23.81% for COPD versus 28.33% for emphysema, P < 0.05). Relative to the other phenotypes, patients with chronic bronchitis were also significantly more likely to be female, nonwhite, and to exercise currently (all P < 0.05), and were significantly less likely to be a current or former smoker (P < 0.05). Controlling for demographic and health characteristics, patients self-identified as having COPD only reported significantly worse physical quality of life (adjusted mean 36.69) and health utilities (adjusted mean 0.65) and significantly more absenteeism (adjusted mean 7.08%), presenteeism (adjusted mean 30.73%), overall work impairment (adjusted mean

  17. A systematic review of primary outcomes and outcome measure reporting in randomized trials evaluating treatments for pre-eclampsia.

    PubMed

    Duffy, James M N; Hirsch, Martin; Gale, Chris; Pealing, Louise; Kawsar, Anusuya; Showell, Marian; Williamson, Paula R; Khan, Khalid S; Ziebland, Sue; McManus, Richard J

    2017-08-13

    An evaluation of outcome reporting is required to develop a core outcome set. To assess primary outcomes and outcome measure reporting in pre-eclampsia trials. Five online databases were searched from inception to January 2016 using terms including "preeclampsia" and "randomized controlled trial". Randomized controlled trials evaluating treatments for pre-eclampsia published in any language were included. Primary outcomes and data on outcome measure reporting were systematically extracted and categorized. Overall, 79 randomized trials including data from 31 615 women were included. Of those, 38 (48%) reported 35 different primary outcomes; 28 were maternal outcomes and seven were fetal/neonatal outcomes. Three randomized trials reported composite outcomes, incorporating between six and nine outcome components. The method of definition or measurement was infrequently or poorly reported. Even when outcomes were consistent across trials, different methods of definition or measurement were frequently described. In randomized trials evaluating interventions for pre-eclampsia, critical information related to the primary outcome, including definition and measurement, is regularly omitted. Developing a core outcome set for pre-eclampsia trials would help to inform primary outcome selection and outcome measure reporting. © 2017 International Federation of Gynecology and Obstetrics.

  18. Association between alendronate, serum alkaline phosphatase level, and heterotopic ossification in individuals with spinal cord injury

    PubMed Central

    Ploumis, Avraam; Donovan, Jayne M.; Olurinde, Mobolaji O.; Clark, Dana M.; Wu, Jason C.; Sohn, Douglas J.; O'Connor, Kevin C.

    2015-01-01

    Context/objective Only sparse evidence exists regarding the effectiveness of oral alendronate (ALN) in the prevention of heterotopic ossification (HO) in patients with spinal cord injury (SCI). The objective of this study is to investigate the protective effect of oral ALN intake on the appearance of HO in patients with SCI. Study design Retrospective database review. Setting A Spinal Cord Unit at a Rehabilitation Hospital. Participants Two hundred and ninety-nine patients with SCI during acute inpatient rehabilitation. Interventions Administration of oral ALN. Outcome measures The incidence of HO during rehabilitation was compared between patients with SCI receiving oral ALN (n = 125) and patients with SCI not receiving oral ALN (n = 174). The association between HO and/or ALN intake with HO risk factors and biochemical markers of bone metabolism were also explored. Results HO developed in 19 male patients (6.35%), however there was no significant difference in the incidence of HO in patients receiving oral ALN or not. The mean odds ratio of not developing versus developing HO given ALN exposure was 0.8. Significant correlation was found between abnormal serum alkaline phosphatase (ALP) levels and HO appearance (P < 0.001) as well as normal serum ALP and ALN intake (P < 0.05). Conclusion Even though there was no direct prevention of HO in patients with SCI by oral ALN intake, abnormal serum ALP was found more frequently in patients with HO development and without oral ALN intake. This evidence could suggest that ALN may play a role in preventing HO, especially in patients with acute SCI with increasing levels of serum ALP. PMID:24820653

  19. Treatment outcomes and prognostic factors of intrahepatic cholangiocarcinoma

    PubMed Central

    DHANASEKARAN, RENUMATHY; HEMMING, ALAN W.; ZENDEJAS, IVAN; GEORGE, THOMAS; NELSON, DAVID R.; SOLDEVILA-PICO, CONSUELO; FIRPI, ROBERTO J.; MORELLI, GIUSEPPE; CLARK, VIRGINIA; CABRERA, RONIEL

    2013-01-01

    The aim of the present study was to determine the treatment outcome and prognostic factors for survival in patients with peripheral intrahepatic cholangiocarcinoma (ICC). A retrospective chart review was performed for patients diagnosed with ICC between 2000 and 2009 at a single institution. We identified a total of 105 patients with ICC. Among them, 63.8% were older than 60 years of age, 50.5% were male and 88.6% were Caucasian. By preoperative imaging approximately half of the patients (50.5%) were surgical candidates and underwent resection. The other half of the patients (49.5%) were unresectable. The unresectable group received chemoradiotherapy (53%) and transarterial chemoembolization (7.7%) as palliative treatments while 23.0% of the patients (12/52) received best supportive care alone. The median survival rates were 16.1 months (13.1–19.2) for the entire cohort, 27.6 months (17.7–37.6) for curative resection, 12.9 months (6.5–19.2) for palliative chemoradiotherapy and 4.9 months (0.4–9.6) for best supportive care (P<0.001). Independent predictors on multivariate analysis were advanced stage at diagnosis and treatment received. In those patients who underwent resection, advanced AJCC stage and presence of microvascular invasion were also independent predictors of poor survival. We concluded that surgery offers the most beneficial curative option and outcome, emphasizing the importance of resectability as a major prognostic factor. The present study also revealed that use of chemoradiotherapy in the adjuvant setting failed to improve survival but its palliative use in those patients with unresectable ICC offered a modest survival advantage over best supportive care. The overriding factors influencing outcome were stage and the presence of microvascular invasion on pathology. PMID:23426976

  20. Fat adherence syndrome following inferior oblique surgery: Treatment and outcomes.

    PubMed

    Merino, Pilar; Blanco, Irene; Liaño, Pilar Gómez de

    2016-01-01

    Describe surgical treatment and results in a group of patients diagnosed and operated on of fat adherence syndrome following inferior oblique surgery. Retrospective study of 6 cases diagnosed and treated of fat adherence syndrome following inferior oblique surgery. Mean age was 24.67 years (range, 5-41), 3 males, 5 unilateral and 1 bilateral. Mean vertical deviation was 16.16pd (range, 4-25). Esotropia was associated in 4 cases, diplopia in other 2, and anomalous head posture in 3. A good outcome was considered when the final deviation was less than 10pd, with mild limitation of elevation, without anomalous head posture, and a negative duction forced test. The final vertical deviation was 6.83pd (range, 0-14). A 2-4mm inferior rectus recession was performed on 4 patients associated to an inferior oblique surgery/exploration. All patients were operated on once, except 1 case. A good outcome was achieved in 3 patients. Anomalous head posture was resolved in 2 of 3 cases. Diplopia resolved after surgery. Only one case achieved orthophoria. Mean evolution time was 34.83 months (range, 6-78). In the treatment of the fat adherence syndrome, an inferior rectus recession is recommended, associated to inferior oblique exploration or surgery. A good favorable outcome was only achieved in half of the cases with surgical treatment. Limitation of elevation could not be completely resolved in any of the patients. Copyright © 2015 Spanish General Council of Optometry. Published by Elsevier España, S.L.U. All rights reserved.

  1. Outcomes of pseudo-severe aortic stenosis under conservative treatment.

    PubMed

    Fougères, Emilie; Tribouilloy, Christophe; Monchi, Mehran; Petit-Eisenmann, Hélène; Baleynaud, Serge; Pasquet, Agnès; Chauvel, Christophe; Metz, Damien; Adams, Catherine; Rusinaru, Dan; Guéret, Pascal; Monin, Jean-Luc

    2012-10-01

    In the setting of low-flow/low-gradient aortic stenosis (LF/LGAS), outcomes of pseudo-severe aortic stenosis (AS) remain poorly described. This study was aimed to assess the outcome of patients with pseudo-severe AS under conservative treatment. Among 305 patients from the European Registry of LF/LGAS, the outcomes of the 107 patients followed under conservative treatment were analysed. Based on the results of dobutamine echocardiography, patients were divided into group IA [left ventricular (LV) contractile reserve present with true-severe AS, n = 43], group IB [pseudo-severe AS (n = 29) defined as LV contractile reserve with a final aortic valve area ≥1.2 cm(2) and a mean transaortic pressure gradient <40 mmHg at peak dobutamine infusion], or group II (exhausted LV contractile reserve, n = 35). The rate of death within 5 years was significantly lower in the group IB (43 ± 11%, n = 10), when compared with the group IA (91 ± 6%, n = 33; P = 0.001) and the group II (100%, n = 23; P < 0.001). The Cox proportional hazard model analysis demonstrated that the hazard ratio for death in the group IB remained significantly lower than in the other groups, even after adjustment for currently established risk factors. Furthermore, the 5-year survival of pseudo-severe AS patients was comparable with that of propensity-matched patients with systolic heart failure and no evidence of valve disease. In patients with pseudo-severe AS, the 5-year survival under conservative treatment is better than in true-severe AS and comparable with that of propensity-matched patients with LV systolic dysfunction and no evidence of valve disease. Further studies are needed to define optimal therapeutic management in these patients.

  2. Anxious distress predicts subsequent treatment outcome and side effects in depressed patients starting antidepressant treatment.

    PubMed

    Gaspersz, Roxanne; Lamers, Femke; Kent, Justine M; Beekman, Aartjan T F; Smit, Johannes H; van Hemert, Albert M; Schoevers, Robert A; Penninx, Brenda W J H

    2017-01-01

    Evidence has shown that the DSM-5 anxious distress specifier captures a clinically valid construct that predicts a worse clinical course. Although of importance for treatment planning and monitoring, however, the specifier's ability to predict treatment outcome is unknown. This is the first study to examine the ability of the DSM-5 anxious distress specifier to predict treatment response and side effects in depressed patients who recently initiated antidepressant treatment. Patients were from the Netherlands Study of Depression and Anxiety, an ongoing longitudinal cohort study. Baseline, 1-year and 2-year follow-up data were used from 149 patients (18-65 years) with current Major Depressive Disorder (MDD) who recently started adequately dosed antidepressant medication. Five self-report items were used to construct the DSM-5 anxious distress specifier. Treatment outcomes were depression severity after 1 year and 2 years, remission of MDD after 2 years and antidepressant side effects during treatment. For comparison, analyses were repeated for comorbid DSM-IV-based anxiety disorders as a predictor. In depressed patients who received antidepressant treatment, the anxious distress specifier (prevalence = 59.1%) significantly predicted higher severity (1 year: B = 1.94, P = 0.001; 2 years: B = 1.63, P = 0.001), lower remission rates (OR = 0.44, P = 0.0496) and greater frequency of side effects (≥4 vs. 0: OR = 2.74, P = 0.061). In contrast, the presence of comorbid anxiety disorders did not predict these treatment outcomes. The anxious distress specifier significantly predicts poorer treatment outcomes as shown by higher depression severity, lower remission rates, and greater frequency of antidepressant side effects in patients with MDD on adequate antidepressant treatment. Therefore, this simple 5-item specifier is of potential great clinical usefulness for treatment planning and monitoring in depressed patients.

  3. Treatment of vasculitic peripheral neuropathy: a retrospective analysis of outcome.

    PubMed

    Mathew, L; Talbot, K; Love, S; Puvanarajah, S; Donaghy, M

    2007-01-01

    Vasculitis of the peripheral nervous system (PNS) is rare. There are no controlled treatment trials, and clinical practice is guided by experience from case series and indirectly by analogy with systemic vasculitis. We identified patients (n=212) with possible vasculitic peripheral neuropathy (VPN) from the neuropathology and neurophysiology records of two centres over 28 years. Case-notes were available for 181, from which, 106 cases of clinicopathological VPN were identified. Adequate treatment data were available in 100; follow-up data, in 93. Of 106 cases, 95 had systemic vasculitis and 11 had vasculitis confined to the PNS. Pharmacological treatment (94/100 cases) was corticosteroid-based, and included cyclophosphamide in 54; 17 received additional agents. Initial stabilization was achieved in all but six. One-year survival was 90.3%. Of the nine who died in the first years (mean age 73 years), seven had received cyclophosphamide, and all but two had severe, multisystem vasculitis. The neurological relapse rate was 10%. Only one relapse occurred after cyclophosphamide treatment. Outcome was reported as good in 72% (78% in those who relapsed). Death and relapse were infrequent in treated patients. Relapse occurred almost exclusively in patients treated with prednisolone alone. Aggressive early treatment with cyclophosphamide may prevent relapse. The current management approach to VPN appears largely effective, especially if cyclophosphamide is used.

  4. [The long-term treatment outcomes of adult osteosarcoma].

    PubMed

    Ługowska, Iwowa; Pieńkowski, Andrzej; Szumera-Ciećkiewicz, Anna; Koseła-Paterczyk, Hanna; Teterycz, Pawel; Głogowski, Maciej; Kozak, Katarzyna; Klimczak, Anna; Falkowski, Slawomir; Rutkowski, Piotr

    2017-04-21

    Osteosarcoma is the most common primary bone tumor. Treatment of osteosarcoma patients is based on chemotherapy as well as surgical resection of primary tumor and distant metastases. Lung metastases are the primary cause of death in this group of patients. The aim of this study is to summarize the 20 years of osteosarcoma treatment outcomes in the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology in Warsaw. Our analysis included clinical data of 299 osteosarcoma patients aged between 14 and 81 years (median 32) treated in Maria Sklodowska-Curie Memorial Cancer Center between 1998 and 2016. The standard therapeutic protocol included perioperative anthracycline-based chemotherapy and surgical resection of primary tumor and distant metastases. The statistical analysis was performed using Kaplan-Meier estimator, log-rank test and Cox proportional hazards model. In analyzed group 38 (13%) patients had distant metastases at the diagnosis. The tumor size was greater than 8 cm in 61% of cases. In the histopathological assessment the most prevalent subtype was the conventional one (diagnosed in 76% of cases) and histological grade 3 (79%). The 5-year survival rate for patients with localized disease reached 46%. The negative prognostic factors included: distant metastases at diagnosis, axial location of primary tumor, unresectability of the primary lesion, higher histological grade, and older age of patients. The best results of the treatment of osteosarcoma patients are achieved with multidisciplinary treatment, and when the reference center supports other healthcare providers in management of diagnostic and treatment procedures of osteosarcoma patients.

  5. Treatment outcome for children and adolescents with conversion disorder.

    PubMed

    Turgay, A

    1990-10-01

    This paper describes the clinical impressions of conversion disorders developed after long term in-depth clinical work with 137 children and adolescents and their families. Almost half of the 89 patients who were directly treated and followed by the author through an integrative child and family therapy approach recovered less than two weeks after the initiation of the treatment. Only three out of 89 patients required longer than four weeks for recovery. The rest responded well to the therapy and recovered with two to four weeks of treatment. Factors associated with positive treatment outcome are: younger age of patient, healthy personality characteristics, lack of psychopathology, insight and treatment compliance, healthy family functioning, acceptance by the family of the psychological nature of the illness, positive feelings towards the child and the family by the staff, lack of internal conflict and inflexible neurotic defences, and early therapeutic interventions. It was found that child and adolescent patients with conversion disorders responded quite well to an integrative, condensed treatment approach.

  6. Improving Outcome of Psychosocial Treatments by Enhancing Memory and Learning

    PubMed Central

    Harvey, Allison G.; Lee, Jason; Williams, Joseph; Hollon, Steven D.; Walker, Matthew P.; Thompson, Monique A.; Smith, Rita

    2014-01-01

    Mental disorders are prevalent and lead to significant impairment. Progress toward establishing treatments has been good. However, effect sizes are small to moderate, gains may not persist, and many patients derive no benefit. Our goal is to highlight the potential for empirically-supported psychosocial treatments to be improved by incorporating insights from cognitive psychology and research on education. Our central question is: If it were possible to improve memory for content of sessions of psychosocial treatments, would outcome substantially improve? This question arises from five lines of evidence: (a) mental illness is often characterized by memory impairment, (b) memory impairment is modifiable, (c) psychosocial treatments often involve the activation of emotion, (d) emotion can bias memory and (e) memory for psychosocial treatment sessions is poor. Insights from scientific knowledge on learning and memory are leveraged to derive strategies for a transdiagnostic and transtreatment cognitive support intervention. These strategies can be applied within and between sessions and to interventions delivered via computer, the internet and text message. Additional novel pathways to improving memory include improving sleep, engaging in exercise and imagery. Given that memory processes change across the lifespan, services to children and older adults may benefit from cognitive support. PMID:25544856

  7. Impregnation of bone chips with alendronate and cefazolin, combined with demineralized bone matrix: a bone chamber study in goats

    PubMed Central

    2012-01-01

    Background Bone grafts from bone banks might be mixed with bisphosphonates to inhibit the osteoclastic response. This inhibition prevents the osteoclasts to resorb the allograft bone before new bone has been formed by the osteoblasts, which might prevent instability. Since bisphosphonates may not only inhibit osteoclasts, but also osteoblasts and thus bone formation, we studied different bisphosphonate concentrations combined with allograft bone. We investigated whether locally applied alendronate has an optimum dose with respect to bone resorption and formation. Further, we questioned whether the addition of demineralized bone matrix (DBM), would stimulate bone formation. Finally, we studied the effect of high levels of antibiotics on bone allograft healing, since mixing allograft bone with antibiotics might reduce the infection risk. Methods 25 goats received eight bone conduction chambers in the cortical bone of the proximal medial tibia. Five concentrations of alendronate (0, 0.5 mg/mL, 1 mg/mL, 2 mg/mL, and 10 mg/mL) were tested in combination with allograft bone and supplemented with cefazolin (200 μg/mL). Allograft not supplemented with alendronate and cefazolin served as control. In addition, allograft mixed with demineralized bone matrix, with and without alendronate, was tested. After 12 weeks, graft bone area and new bone area were determined with manual point counting. Results Graft resorption decreased significantly (p < 0.001) with increasing alendronate concentration. The area of new bone in the 1 mg/mL alendronate group was significantly (p = 0.002) higher when compared to the 10 mg/mL group. No differences could be observed between the group without alendronate, but with demineralized bone, and the control groups. Conclusions A dose-response relationship for local application of alendronate has been shown in this study. Most new bone was present at 1 mg/mL alendronate. Local application of cefazolin had no effect on bone remodelling. PMID:22443362

  8. Pediatric malignancies, treatment outcomes and abandonment of pediatric cancer treatment in Zambia.

    PubMed

    Slone, Jeremy S; Chunda-Liyoka, Catherine; Perez, Marta; Mutalima, Nora; Newton, Robert; Chintu, Chifumbe; Kankasa, Chipepo; Chipeta, James; Heimburger, Douglas C; Vermund, Sten H; Friedman, Debra L

    2014-01-01

    There exist significant challenges to the receipt of comprehensive oncologic treatment for children diagnosed with cancer in sub-Saharan Africa. To better define those challenges, we investigated treatment outcomes and risk factors for treatment abandonment in a cohort of children diagnosed with cancer at the University Teaching Hospital (UTH), the site of the only pediatric oncology ward in Zambia. Using an established database, a retrospective cohort study was conducted of children aged 0-15 years admitted to the pediatric oncology ward between July 2008 and June 2010 with suspected cancer. Diagnosis, mode of diagnosis, treatment outcome, and risk factors for abandonment of treatment were abstracted from this database and clinical medical records. Among 162 children treated at the UTH during the study time period that met inclusion criteria, only 8.0% completed a treatment regimen with most of the patients dying during treatment or abandoning care. In multivariable analysis, shorter distance from home to the UTH was associated with a lower risk of treatment abandonment (Adjusted Odds Ratio [aOR]  = 0.48 (95% confidence interval [CI] 0.23-0.97). Conversely maternal education less than secondary school was associated with increased risk for abandonment (aOR = 1.65; 95% CI 1.05-2.58). Despite availability of dedicated pediatric oncology treatment, treatment completion rates are poor, due in part to the logistical challenges faced by families, low educational status, and significant distance from the hospital. Alternative treatment delivery strategies are required to bring effective pediatric oncology care to the patients in need, as their ability to come to and remain at a central tertiary care facility for treatment is limited. We suggest that the extensive system now in place in most of sub-Saharan Africa that sustains life-long antiretroviral therapy for children with human immunodeficiency virus (HIV) infection be adapted for pediatric cancer treatment to

  9. Pediatric Malignancies, Treatment Outcomes and Abandonment of Pediatric Cancer Treatment in Zambia

    PubMed Central

    Slone, Jeremy S.; Chunda-Liyoka, Catherine; Perez, Marta; Mutalima, Nora; Newton, Robert; Chintu, Chifumbe; Kankasa, Chipepo; Chipeta, James; Heimburger, Douglas C.; Vermund, Sten H.; Friedman, Debra L.

    2014-01-01

    Background There exist significant challenges to the receipt of comprehensive oncologic treatment for children diagnosed with cancer in sub-Saharan Africa. To better define those challenges, we investigated treatment outcomes and risk factors for treatment abandonment in a cohort of children diagnosed with cancer at the University Teaching Hospital (UTH), the site of the only pediatric oncology ward in Zambia. Methods Using an established database, a retrospective cohort study was conducted of children aged 0–15 years admitted to the pediatric oncology ward between July 2008 and June 2010 with suspected cancer. Diagnosis, mode of diagnosis, treatment outcome, and risk factors for abandonment of treatment were abstracted from this database and clinical medical records. Results Among 162 children treated at the UTH during the study time period that met inclusion criteria, only 8.0% completed a treatment regimen with most of the patients dying during treatment or abandoning care. In multivariable analysis, shorter distance from home to the UTH was associated with a lower risk of treatment abandonment (Adjusted Odds Ratio [aOR] = 0.48 (95% confidence interval [CI] 0.23–0.97). Conversely maternal education less than secondary school was associated with increased risk for abandonment (aOR = 1.65; 95% CI 1.05–2.58). Conclusions Despite availability of dedicated pediatric oncology treatment, treatment completion rates are poor, due in part to the logistical challenges faced by families, low educational status, and significant distance from the hospital. Alternative treatment delivery strategies are required to bring effective pediatric oncology care to the patients in need, as their ability to come to and remain at a central tertiary care facility for treatment is limited. We suggest that the extensive system now in place in most of sub-Saharan Africa that sustains life-long antiretroviral therapy for children with human immunodeficiency virus (HIV) infection

  10. Whole body vibration exercise improves body balance and walking velocity in postmenopausal osteoporotic women treated with alendronate: Galileo and Alendronate Intervention Trail (GAIT).

    PubMed

    Iwamoto, J; Sato, Y; Takeda, T; Matsumoto, H

    2012-09-01

    A randomized controlled trial was conducted to determine the effect of 6 months of whole body vibration (WBV) exercise on physical function in postmenopausal osteoporotic women treated with alendronate. Fifty-two ambulatory postmenopausal women with osteoporosis (mean age: 74.2 years, range: 51-91 years) were randomly divided into two groups: an exercise group and a control group. A four-minute WBV exercise was performed two days per week only in the exercise group. No exercise was performed in the control group. All the women were treated with alendronate. After 6 months of the WBV exercise, the indices for flexibility, body balance, and walking velocity were significantly improved in the exercise group compared with the control group. The exercise was safe and well tolerated. The reductions in serum alkaline phosphatase and urinary cross-linked N-terminal telopeptides of type I collagen during the 6-month period were comparable between the two groups. The present study showed the benefit and safety of WBV exercise for improving physical function in postmenopausal osteoporotic women treated with alendronate.

  11. Congenital syndactyly: outcome of surgical treatment in 131 webs.

    PubMed

    Vekris, Marios D; Lykissas, Marios G; Soucacos, Panayiotis N; Korompilias, Anastasios V; Beris, Alexandros E

    2010-03-01

    Congenital syndactyly is one of the most common congenital hand differences and various methods of surgical treatment have been described since the 19th century. Nevertheless, unsatisfactory results including web creep, flexion contractures, and rotational deformities of the fingers are still reported. This study presents the outcome of syndactyly release in 131 webs in 78 patients. The sex ratio was 40 males/38 females. The age ranged from 4 months to 22 years (average: 4 y). In the majority of the webs the result was good or excellent. The type of flaps used for the reconstruction of the web was important as the combination of a dorsal rectangular and 2 volar triangular flaps gave superior results than the use of 2 triangular flaps. The less rewarding overall outcome was obtained in the presence of associated differences of the involved fingers, that is, complex complicated syndactyly and in the cases of delayed correction. Use of a dorsal rectangular flap in combination with 2 volar triangular flaps and use of full thickness skin grafts, ensure a satisfactory outcome and minimize the number of operations per web.

  12. Does pregnancy affect outcome of methadone maintenance treatment?

    PubMed

    Crandall, Cynthia; Crosby, Ross D; Carlson, Gregory A

    2004-06-01

    Studies of pregnant women receiving methadone maintenance have tended to focus on teratogenic, prenatal, and neonatal issues. We are not aware of any controlled studies comparing pregnant to non-pregnant heroin-addicted women in methadone treatment. This article presents findings from a study examining treatment outcome between pregnant and non-pregnant participants in a metropolitan methadone-maintenance program. Participants were 51 pregnant women and 51 non-pregnant women enrolled in a methadone maintenance program between 1994 and 2003. Groups were compared on demographic characteristics, psychiatric comorbidity, urinalysis results and retention rates. Groups were comparable in terms of most demographic characteristics and severity of addiction at intake. Groups did not differ significantly in terms of urinalysis results or retention rates. While most women reduced their drug use, a majority of both groups continued to use illicit drugs at least occasionally. Psychiatric comorbidity was significantly different with the non-pregnant group being more psychiatrically disordered. Clinical implications are discussed.

  13. Review of thumb carpometacarpal arthritis classification, treatment and outcomes

    PubMed Central

    Gillis, Joshua; Calder, Kevin; Williams, Jason

    2011-01-01

    Thumb carpometacarpal osteoarthritis (CMC OA) is a common disease, affecting up to 11% and 33% of men and women in their 50s and 60s, respectively, which leads to pain, laxity and weakness of the CMC joint. Based on the staging of the CMC OA, different forms of treatment can be used, including both conservative and surgical measures. Surgical options include osteotomy, trapezial excision, ligament reconstruction with or without tendon interposition, and various prosthetic interpositional implants with or without trapezial excision. The present article reviews the staging of CMC OA, the evaluation of hand function using patient-reported questionnaires, and outcomes of both conservative and surgical treatments. The present review also introduces a commercially available interpositional spacer surgical technique for CMC OA and the early evidence that the literature has shown for improving hand function, strength and stability of the thumb CMC joint postoperatively. PMID:23204884

  14. Does the type of treatment supporter influence tuberculosis treatment outcomes in Zimbabwe?

    PubMed

    Mlilo, N; Sandy, C; Harries, A D; Kumar, A M V; Masuka, N; Nyathi, B; Edginton, M; Isaakidis, P; Manzi, M; Siziba, N

    2013-06-21

    Zimbabwe National Tuberculosis Guidelines advise that direct observation of anti-tuberculosis treatment (DOT) can be provided by a family member/relative as a last resort. In 2011, in Nkayi District, of 763 registered tuberculosis (TB) patients, 59 (8%) received health facility-based DOT, 392 (51%) received DOT from a trained community worker and 306 (40%) from a family member/relative. There were no differences in TB treatment outcomes between the three DOT groups, apart from a higher frequency rate of 'no reported outcomes' for those receiving family-based DOT. Family members should be trained to use a suitable DOT support package.

  15. Outcome of Surgical Treatment of 200 Children With Cushing's Disease

    PubMed Central

    Lonser, Russell R.; Wind, Joshua J.; Nieman, Lynnette K.; Weil, Robert J.; DeVroom, Hetty L.

    2013-01-01

    Context: Factors influencing the outcome of surgical treatment of pediatric Cushing's disease (CD) have not been fully established. Objective: The aim of this study was to examine features influencing the outcome of surgery for pediatric CD. Design: In this prospective observational study, the clinical, imaging, endocrinological, and operative outcomes were analyzed in consecutive patients treated at the National Institutes of Health (NIH) from 1982 through 2010. Setting: The study was conducted in a tertiary referral center. Results: Two hundred CD patients (106 females, 94 males) were included. Mean age at symptom development was 10.6 ± 3.6 years (range, 4.0 to 19.0 y). Mean age at NIH operation was 13.7 ± 3.7 years. Twenty-seven patients (13%) had prior surgery at another institution. Magnetic resonance imaging identified adenomas in 97 patients (50%). When positive, magnetic resonance imaging accurately defined a discrete adenoma in 96 of the 97 patients (99%), which was more accurate than the use of ACTH ratios during inferior petrosal sinus sampling to determine adenoma lateralization (accurate in 72% of patients without prior surgery). A total of 195 of the 200 patients (98%) achieved remission after surgery (189 [97%] were hypocortisolemic; 6 [3%] were eucortisolemic postoperatively). Factors associated with initial remission (P < .05) included identification of an adenoma at surgery, immunohistochemical ACTH-producing adenoma, and noninvasive ACTH adenoma. Younger age, smaller adenoma, and absence of cavernous sinus wall or other dural invasion were associated with long-term remission (P < .05). A minimum morning serum cortisol of less than 1 μg/dl after surgery had a positive predictive value for lasting remission of 96%. Conclusions: With rare disorders, such as pediatric CD, enhanced outcomes are obtained by evaluation and treatment at centers with substantial experience. Resection of pituitary adenomas in pediatric CD in that setting can be safe

  16. Childhood trauma and treatment outcome in bipolar disorder.

    PubMed

    Cakir, Sibel; Tasdelen Durak, Rumeysa; Ozyildirim, Ilker; Ince, Ezgi; Sar, Vedat

    2016-01-01

    The aim of the present study was to investigate the potential influence of childhood trauma on clinical presentation, psychiatric comorbidity, and long-term treatment outcome of bipolar disorder. A total of 135 consecutive patients with bipolar disorder type I were recruited from an ongoing prospective follow-up project. The Childhood Trauma Questionnaire and the Structured Clinical Interview for DSM-IV Axis I Disorders were administered to all participants. Response to long-term treatment was determined from the records of life charts of the prospective follow-up project. There were no significant differences in childhood trauma scores between groups with good and poor responses to long-term lithium treatment. Poor responders to long-term anticonvulsant treatment, however, had elevated emotional and physical abuse scores. Lifetime diagnosis of posttraumatic stress disorder (PTSD) was associated with poor response to lithium treatment and antidepressant use but not with response to treatment with anticonvulsants. Total childhood trauma scores were related to the total number of lifetime comorbid psychiatric disorders, antidepressant use, and the presence of psychotic features. There were significant correlations between all types of childhood abuse and the total number of lifetime comorbid psychiatric diagnoses. Whereas physical neglect was related to the mean severity of the mood episodes and psychotic features, emotional neglect was related to suicide attempts. A history of childhood trauma or PTSD may be a poor prognostic factor in the long-term treatment of bipolar disorder. Whereas abusive experiences in childhood seem to lead to nosological fragmentation (comorbidity), childhood neglect tends to contribute to the severity of the mood episodes.

  17. Inhibition of particulate debris-induced osteolysis by alendronate in a rat model.

    PubMed

    Thadani, Peter J; Waxman, Bryan; Sladek, Eduard; Barmada, Riad; Gonzalez, Mark H

    2002-01-01

    A rat model was used to study the efficacy of alendronate therapy in inhibition of particle-induced periprosthetic osteolysis. A prosthesis was simulated by inserting a cylindrical polymethylmethacrylate plug into the distal femur of 24 rats allowing the plug to communicate with the joint space. Intra-articular injections of irregularly-shaped ultra-high molecular weight polyethylene particles of 20-200 pm in diameter were administered at 2-week intervals. The rats were randomized into two groups (n=12 each). Group A rats received twice weekly subcutaneous injections of alendronate sodium while group B rats received injections of saline vehicle only. At 10 weeks all rats were sacrificed. The distal femurs were harvested and axial sections were prepared for histologic analysis. Each section was graded on a scale of 1-4, quantifying the degree of osteolysis surrounding the polymethylmethacrylate plug. Microscopic examination showed a significant (P<.0001) difference in the amount of periprosthetic bone. Femurs from group A treated with alendronate demonstrated mostly normal or near-normal periprosthetic trabeculations, whereas femurs from group B treated with saline showed extensive bone resorption. There was no qualitative difference in the inflammatory cellular response between the groups. This study established the ability of alendronate to inhibit the osteoclastic-mediated osteolysis around joint implants.

  18. The Icatibant Outcome Survey: treatment of laryngeal angioedema attacks

    PubMed Central

    Aberer, Werner; Bouillet, Laurence; Caballero, Teresa; Maurer, Marcus; Fabien, Vincent; Zanichelli, Andrea

    2016-01-01

    Objective To characterize the management and outcomes of life-threatening laryngeal attacks of hereditary angioedema (HAE) treated with icatibant in the observational Icatibant Outcome Survey (NCT01034969) registry. Methods This retrospective analysis was based on data from patients with HAE type I/II who received healthcare professional-administered or self-administered icatibant to treat laryngeal attacks between September 2008 and May 2013. Results Twenty centers in seven countries contributed data. Overall, 42 patients with HAE experienced 67 icatibant-treated laryngeal attacks. Icatibant was self-administered for 62.3% of attacks (healthcare professional-administered, 37.7%). One icatibant injection was used for 87.9% of attacks, with rescue or concomitant medication used for 9.0%. The median time to treatment was 2.0 h (n=31 attacks) and the median time to resolution was 6.0 h (n=35 attacks). Conclusions This analysis describes successful use of icatibant for the treatment of laryngeal HAE attacks in a real-world setting. PMID:27116379

  19. Memory modification as an outcome variable in anxiety disorder treatment.

    PubMed

    Tryon, Warren W; McKay, Dean

    2009-05-01

    Learning and memory are interdependent processes. Memories are learned, and cumulative learning requires memory. It is generally accepted that learning contributes to psychopathology and consequently to pertinent memory formation. Neuroscience and psychological research have established that memory is an active reconstructive process that is influenced by thoughts, feelings, and behaviors including post-event information. Recent research on the treatment of anxiety disorders using medications (i.e., d-cyclcloserine) to alter neurological systems associated with memory used in conjunction with behavior therapy suggests that memory is part of a central mechanism in the etiology and maintenance of these conditions. The main thesis of this article is that learning-based interventions create new memories that may modify existing ones. This raises the possibility of using such memory modifications to measure intervention outcome. A connectionist context for understanding this phenomenon and informing intervention is provided, with specific reference to post-traumatic stress disorder, obsessive-compulsive disorder, and generalized anxiety disorder. Recommendations for future research examining the role of memory change in treatment outcome are suggested.

  20. Tuberculous spondylodiscitis: epidemiology, clinical features, treatment, and outcome.

    PubMed

    Trecarichi, E M; Di Meco, E; Mazzotta, V; Fantoni, M

    2012-04-01

    Tuberculous spondylodiscitis (TS) is a rare but serious clinical condition which may lead to severe deformity and early or late neurological complications. To discuss certain aspects of the approach to TSs, focusing upon epidemiology, diagnosis, and treatment outcome. For the purpose of this review, a literature search was performed using the Pubmed database through to 19th October 2011 to identify studies published in the last 20 years, concerned in epidemiological, clinical, diagnostic, and therapeutical aspects of TS in adults. Only studies drafted in English language and reporting case series of more than 20 patients have been included. TS has been reported to accounts for 1-5% of all TB cases, and for about 50% of the cases of articulo-skeletal TB infections. Despite the actual availability of more effective diagnostic tools, early recognition of TS remains difficult and a high index of suspicion is needed due to the chronic nature of the disease and its insidious and variable clinical presentation. A prompt diagnosis is required to improve long term outcome, and a microbiological confirmation is recommended to enable appropriate choice of anti-mycobacterial agents. Surgery has an important role in alleviating pain, correcting deformities and neurological impairment, and restoring function. Further studies are required to assess the appropriate duration of anti-microbial treatment, also in regarding of a combined surgical approach.

  1. Comparison of central adjudication of outcomes and onsite outcome assessment on treatment effect estimates.

    PubMed

    Ndounga Diakou, Lee Aymar; Trinquart, Ludovic; Hróbjartsson, Asbjørn; Barnes, Caroline; Yavchitz, Amelie; Ravaud, Philippe; Boutron, Isabelle

    2016-03-10

    Assessment of events by adjudication committees (ACs) is recommended in multicentre randomised controlled trials (RCTs). However, its usefulness has been questioned. The aim of this systematic review was to compare 1) treatment effect estimates of subjective clinical events assessed by onsite assessors versus by AC, and 2) treatment effect estimates according to the blinding status of the onsite assessor as well as the process used to select events to adjudicate. We searched Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE, PsycINFO, CINAHL and Google Scholar (25 August 2015 as the last updated search date), using a combination of terms to retrieve RCTs with commonly used terms to describe ACs. We included all reports of RCTs and the published RCTs included in reviews and meta-analyses that reported the same subjective outcome event assessed by both an onsite assessor and an AC. We extracted the odds ratio (OR) from onsite assessment and the corresponding OR from AC assessment and calculated the ratio of the odds ratios (ROR). A ratio of odds ratios < 1 indicated that onsite assessors generated larger effect estimates in favour of the experimental treatment than ACs. Data from 47 RCTs (275,078 patients) were used in the meta-analysis. We excluded 11 RCTs because of incomplete outcome data to calculate the OR for onsite and AC assessments. On average, there was no difference in treatment effect estimates from onsite assessors and AC (combined ROR: 1.00, 95% confidence interval (CI) 0.97 to 1.04; I(2) = 0%, 47 RCTs). The combined ROR was 1.00 (95% CI 0.96 to 1.04; I(2) = 0%, 35 RCTs) when onsite assessors were blinded; 0.76 (95% CI 0.48 to 1.12, I(2) = 0%, two RCTs) when AC assessed events identified independently from unblinded onsite assessors; and 1.11 (95% CI 0.96 to 1.27, I(2) = 0%, 10 RCTs) when AC assessed events identified by unblinded onsite assessors. However, there was a statistically significant interaction between these subgroups

  2. TB treatment in a chronic complex emergency: treatment outcomes and experiences in Somalia.

    PubMed

    Liddle, Karin Fischer; Elema, Riekje; Thi, Sein Sein; Greig, Jane; Venis, Sarah

    2013-11-01

    Médecins Sans Frontières (MSF) provides TB treatment in Galkayo and Marere in Somalia. MSF international supervisory staff withdrew in 2008 owing to insecurity but maintained daily communication with Somali staff. In this paper, we aimed to assess the feasibility of treating TB in a complex emergency setting and describe the programme adaptations implemented to facilitate acceptable treatment outcomes. Routinely collected treatment data from 2005-2012 were retrospectively analysed. In multivariate analyses, factors associated with successful outcome (cure or completion versus failure, death and default) were assessed, including the presence of international supervisory staff. Informal interviews were conducted with Somali staff regarding programmatic factors affecting patient management and perceived reasons for default. In total, 6167 patients were admitted (34.8% female; median age 24.0 years [IQR 13.0-38.0 years]). Treatment success was 79% (programme range 69-87%). Presence of international staff did not improve outcomes (adjusted OR 0.85, 95% CI 0.66-1.09; p=0.27). Perceived reasons for default included being away from family, nomadic group, insecurity, travel cost, need to return to grazing land or feeling better. Despite the challenges, a high percentage of patients were successfully treated. Treatment outcomes were not adversely affected by withdrawal of international supervisory staff.

  3. Oncological and surgical outcome after treatment of pelvic sarcomas

    PubMed Central

    Puchner, Stephan E.; Funovics, Philipp T.; Böhler, Christoph; Kaider, Alexandra; Stihsen, Christoph; Hobusch, Gerhard M.; Panotopoulos, Joannis; Windhager, Reinhard

    2017-01-01

    Background and objectives Treatment of pelvic tumors remains challenging due to complex anatomy, poor oncological outcome and high complication rates. We sought to investigate the long-term oncological and surgical outcome of these patients. Methods Between 1980 and 2012, 147 patients underwent surgical treatment for pelvic sarcoma. Histological diagnosis was Chondrosarcoma in 54, Ewing’s Sarcoma/PNET in 37, Osterosarcoma in 32 and others in 24 patients. Statistical analysis for the evaluation of oncological and surgical outcome was performed by applying Cox proportional hazards regression and Fine-Gray regression models for competing risk (CR) endpoints. Results The estimated overall survival (OS) to death was 80%, 45% and 37% at 1, 5 and 10 years, respectively. Univariate analyses revealed a statistically significant unadjusted influence of age age (p = 0.038; HR = 1.01), margin (p = 0.043; HR = 0.51) and grade (p = 0.001; HR = 2.27) on OS. Considering the multivariable model, grade (p = 0.005; HR = 3.04) and tumor volume (p = 0.014; HR = 1.18) presented themselves as independent prognostic factors on OS. CR analysis showed a cumulative incidence for major complication of 31% at 5 years. Endoprosthetic reconstruction had a higher risk for experiencing a major complication (p<0.0001) and infection (p = 0.001). Conclusions Pelvic resections are still associated with a high incidence of complications. Patients with pelvic reconstruction and high volume tumors are especially at risk. Consequently, a cautious decision-making process is necessary when indicating pelvic reconstruction, although a restrictive approach to pelvic reconstruction is not necessarily reasonable when the other option is major amputation. PMID:28199377

  4. Analysis of treatment outcomes for primary tonsillar lymphoma

    PubMed Central

    Lee, Yun Hee; Cho, Seok Goo; Jung, Seung Eun; Kim, Sung Hoon; O, Joo Hyun; Park, Gyeong Sin; Yang, Suk Woo; Lee, In Seok; Rhee, Chin Kook; Choi, Byung Ock

    2016-01-01

    Purpose Although each Waldeyer’s ring sub-site is considered an independent prognostic factor, few studies have assessed the prognosis and treatment of tonsillar lymphoma. Treatment outcomes were analyzed in patients with primary tonsillar lymphoma who were treated with chemotherapy and radiotherapy (RT). Materials and Methods Nineteen patients with diffuse large B-cell lymphoma were evaluated, with a median follow-up of 53 months. Age, sex, and histology, amongst other factors, were reviewed. Progression-free survival (PFS) and overall survival (OS) rates were analyzed. Results Most patients had Ann Arbor stage I-II (94.7%), IPI score of 0 (89.5%), and complete remission after chemotherapy (89.5%). The 5-year PFS and OS rates were 74.6% and 80%, respectively. In univariate analysis, the rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) regimen resulted in a better PFS than the cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen (88.9% vs. 50.0%; p = 0.053). RT dose was related to the survival outcome (p = 0.010 for PFS, p = 0.044 for OS). Patients were classified into the CHOP + RT (>40 Gy) group and R-CHOP + RT (≤40 Gy) group. The 5-year PFS rates were 50% in the CHOP + RT group, and 100 % in the R-CHOP + RT group (p = 0.018). The 5-year OS rates were 66.7% and 100%, respectively (p = 0.087). Conclusion Primary tonsillar lymphoma patients typically have favorable outcomes. Chemotherapy (R-CHOP) combined with relatively lower dose consolidative RT may be safe and effective for primary tonsillar lymphoma. PMID:28030899

  5. 3-dimensional analysis of regenerative endodontic treatment outcome.

    PubMed

    EzEldeen, Mostafa; Van Gorp, Gertrude; Van Dessel, Jeroen; Vandermeulen, Dirk; Jacobs, Reinhilde

    2015-03-01

    A growing body of evidence supports the regeneration potential of dental tissues after regenerative endodontic treatment (RET). Nevertheless, a standard method for the evaluation of RET outcome is lacking. The aim of this study was to develop a standardized quantitative method for RET outcome analysis based on cone-beam computed tomographic (CBCT) volumetric measurements. Five human teeth embedded in mandibular bone samples were scanned using both an Accuitomo 170 CBCT machine (Morita, Kyoto, Japan) and a SkyScan 1174 micro-computed tomographic (μCT) system (SkyScan, Antwerp, Belgium). For subsequent clinical application, clinical data and low-dose CBCT scans (preoperatively and follow-up) from 5 immature permanent teeth treated with RET were retrieved. In vitro and clinical 3-dimensional image data sets were imported into a dedicated software tool. Two segmentation steps were applied to extract the teeth of interest from the surrounding tissue (livewire) and to separate tooth hard tissue and root canal space (level set methods). In vitro and clinical volumetric measurements were assessed separately for differences using Wilcoxon matched pairs test. Pearson correlation analysis and Bland-Altman plots were used to evaluate the relation and agreement between the segmented CBCT and μCT volumes. The results showed no statistical differences and strong agreement between CBCT and μCT volumetric measurements. Volumetric comparison of the root hard tissue showed significant hard tissue formation. (The mean volume of newly formed hard tissue was 27.9 [±10.5] mm(3) [P < .05]). Analysis of 3-dimensional data for teeth treated with RET offers valuable insights into the treatment outcome and patterns of hard tissue formation. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  6. Impact of treatment protocol on outcome of localized Ewing's sarcoma

    PubMed Central

    Nasaka, Srividya; Gundeti, Sadashivudu; Ganta, Ranga Raman; Arigela, Ravi Sankar; Linga, Vijay Gandhi; Maddali, Lakshmi Srinivas

    2016-01-01

    Background: The outcome of localized Ewing's sarcoma has improved with multi-disciplinary approach. Survivals of Ewing's sarcoma from the Asian countries differed between centers. Methods: We retrospectively analyzed the records of newly diagnosed localized Ewing's sarcoma patients from 2002 to 2012. The patients were analyzed in three groups; Group 1(2002-2004) who received non-ifosfomide based regimens, Group 2(2005-2008) who received VDC/IE for 12 cycles, and Group 3(2009-2012), who received VDC/IE for 17 cycles. The groups were compared for their baseline characteristics, treatment protocol and outcome. Results: Seventy three patients were included in the study. The median age of presentation was 15 years, with slight male predominance. Axial primary was seen in 62%. The median RFS of the three groups was 26.4, 31.4 and 36.8 months respectively (P = 0.0018). The median OS was 27.9, 35 and 43 months respectively (P = 0.0007). At a median follow-up of 35 months, the 3 year RFS and OS for the three treatment groups were 17%, 31%, 60% and 35%, 45% and 70% respectively. Larger tumor size, axial primary, high LDH were associated with poorer survival. Radiotherapy was associated with inferior local control and survival. Conclusions: We found that the survival of our ESFT patients improved over time with intensified multiagent chemotherapy and with lesser time to local therapy. But the results were still inferior to those reported in literature. We had majority of patients presenting in axial site and radiotherapy as the predominant mode of local control. The outcome may further improve with surgery as local control procedure. PMID:28032089

  7. Treatment beliefs, health behaviors and their association with treatment outcome in type 2 diabetes

    PubMed Central

    von Arx, Lill-Brith Wium; Gydesen, Helge; Skovlund, Søren

    2016-01-01

    Objective While the prevalence of type 2 diabetes is growing, it is increasingly well recognized that treatment outcomes in primary care practice are often suboptimal. The aim of this study is to examine the extent to which treatment beliefs and health behaviors predict diabetes health outcome as measured by glycated hemoglobin (HbA1c) level, blood pressure, and lipid profile. Research design and methods This was a large-scale cross-sectional, registry-based study involving a well-defined type 2 diabetes population, in the county of Funen, Denmark. Registry data were combined with a 27-item self-reported survey administered to all insulin-treated people in the registry (n=3160). The survey was constructed to operationalize key concepts of diabetes management, diabetes treatment beliefs, and health behaviors. Results In total, 1033 respondents answered the survey. The majority of treatment beliefs and health behaviors examined were predictors of glycemic control and, to a large extent, lipid profile. Absence from, or a low frequency of, self-measured blood glucose, non-adherence to general medical advice and the prescribed treatment, a low primary care utilization, and perceived low treatment efficacy were factors positively associated with HbA1c levels, s-cholesterol, and low-density lipoprotein. Conversely, infrequent self-measured blood glucose was associated with a significantly higher likelihood of having a blood pressure below 130/80 mm Hg. Perceived low treatment efficacy was the only health belief associated with poorer levels of health outcome other than HbA1c. Conclusions Health behaviors were stronger predictors for health outcomes than treatment beliefs. Self-reported adherence to either the treatment regimen or general medical advice most consistently predicted both glycemic control and cardiovascular risk factors. PMID:27110367

  8. Displaced juvenile Tillaux fractures : Surgical treatment and outcome.

    PubMed

    Tiefenboeck, Thomas M; Binder, Harald; Joestl, Julian; Tiefenboeck, Michael M; Boesmueller, Sandra; Krestan, Christian; Schurz, Mark

    2017-03-01

    Approximately 15 % of all juvenile injuries of the long bones involve the epiphyseal growth plate, and 2.9 % of these are juvenile Tillaux fractures. The Tillaux fracture is of great importance because it involves a major weight-bearing articular surface. Treatment protocols in the literature are not uniform for this kind of fracture, and numerous case reports can be found describing various treatment methods. The aim of this study was to present the clinical outcome at long-term follow-up after treatment of displaced Tillaux fractures. In all, 168 children and adolescent patients with physeal injuries of the distal tibia were treated from 2003 to 2012. Seven patients were identified as having Tillaux fractures requiring surgical treatment and therefore were included in our study and evaluated retrospectively. Seven patients with Tillaux fractures underwent surgical reconstruction by open or closed reduction. Excellent results were achieved in 90 % of the patients, with a mean Foot and Ankle Score at the last follow-up of 98.71. Anatomical reduction is required for every displaced epiphyseal fracture via open reduction and internal fixation, especially in cases with ≥2 mm fragment displacement. Plaster cast immobilization and non-weight-bearing mobilization for at least 4 weeks might be a good way of ensuring optimal surgical results and preventing complications.

  9. Optimizing Population Health and Economic Outcomes: Innovative Treatment for BPH

    PubMed Central

    2013-01-01

    Optimizing Population Health and Economic Outcomes: Innovative Treatment for Benign Prostatic Hyperplasia (BPH) Transcribed and adapted for publication by Janice L. Clarke, RN, BBA Editorial: David B. Nash, MD, MBA   S-2 Introduction   S-2 Benign Prostatic Hyperplasia (BPH)   S-3 • Overview   S-3• Current BPH Treatment Paradigm   S-4• BPH Continuum of Care: Bladder Health   S-5 New Treatment Option for BPH   S-5 • The UroLift® System   S-6• Positioning of UroLift® in BPH Treatment Paradigm   S-7 New Value Proposition   S-8 • Addressing Bladder Health: Breaking the Cycle   S-8• Cost Benefit Analysis: The Big Picture   S-8 Patient and Family Engagement   S-10 Summary   S-11 PMID:22823180

  10. Criminal Justice Outcomes after Engagement in Outpatient Substance Abuse Treatment

    PubMed Central

    Garnick, Deborah W.; Horgan, Constance M.; Acevedo, Andrea; Lee, Margaret T.; Panas, Lee; Ritter, Grant A.; Dunigan, Robert; Bidorini, Alfred; Campbell, Kevin; Haberlin, Karin; Huber, Alice; Lambert-Wacey, Dawn; Leeper, Tracy; Reynolds, Mark; Wright, David

    2013-01-01

    The relationship between engagement in outpatient treatment facilities in the public sector and subsequent arrest is examined for clients in Connecticut, New York, Oklahoma and Washington. Engagement is defined as receiving another treatment service within 14 days of beginning a new episode of specialty treatment and at least two additional services within the next 30 days. Data are from 2008 and survival analysis modeling is used. Survival analyses express the effects of model covariates in terms of “hazard ratios,” which reflect a change in the likelihood of outcome because of the covariate. Engaged clients had a significantly lower hazard of any arrest than non-engaged in all four states. In NY and OK, engaged clients also had a lower hazard of arrest for substance-related crimes. In CT, NY, and OK engaged clients had a lower hazard of arrest for violent crime. Clients in facilities with higher engagement rates had a lower hazard of any arrest in NY and OK. Engaging clients in outpatient treatment is a promising approach to decrease their subsequent criminal justice involvement. PMID:24238717

  11. Factors determining esthetic outcome after breast cancer conservative treatment.

    PubMed

    Cardoso, Maria J; Cardoso, Jaime; Santos, Ana C; Vrieling, Conny; Christie, David; Liljegren, Göran; Azevedo, Isabel; Johansen, Jørgen; Rosa, José; Amaral, Natália; Saaristo, Rauni; Sacchini, Virgilio; Barros, Henrique; Oliveira, Manuel C

    2007-01-01

    The aim of this study was to evaluate the factors that determine esthetic outcome after breast cancer conservative treatment, based on a consensual classification obtained with an international consensus panel. Photographs were taken from 120 women submitted to conservative unilateral breast cancer surgery (with or without axillary surgery) and radiotherapy. The images were sent to a panel of observers from 13 different countries and consensus on the classification of esthetic result (recorded as excellent, good, fair or poor) was obtained in 113 cases by means of a Delphi method. For each patient, data were collected retrospectively regarding patient characteristics, tumor, and treatment factors. Univariate and multivariate analysis were used to evaluate the correlation between these factors and overall cosmetic results. On univariate analysis, younger and thinner patients as well as patients with lower body mass index (BMI) and premenopausal status obtained better cosmetic results. In the group of tumor- and treatment-related factors, larger removed specimens, clearly visible scars, the use of chemotherapy and longer follow-up period were associated with less satisfactory results. On multivariate analysis, only BMI and scar visibility maintained a significant association with cosmesis. BMI and scar visibility are the only factors significantly associated with cosmetic results of breast cancer conservative treatment, as evaluated by an international consensus panel.

  12. The Prevalence and Treatment Outcomes of Primary Tooth Injuries

    PubMed Central

    Arikan, Volkan; Sari, Saziye; Sonmez, Hayriye

    2010-01-01

    Objectives: The aim of the present study was to evaluate the type and prevalence of primary tooth injuries, as well as their treatment and treatment outcomes, among children referred to the Department of Pedodontics at the Ankara University Faculty of Dentistry in Turkey. Methods: The study population consisted of patients applying to the department with a primary tooth injury over a period of 21 months. Fifty-one patients presented with trauma to 99 primary teeth. Clinical and radiographic examinations were conducted on each patient. Age, sex, time, cause of injury, and number of teeth affected were recorded, and the type of trauma was identified according to Andreasen’s classification. The teeth were treated by one of the authors. Results: The majority of trauma occurred between the ages of 2 and 4. The most common type of injury was lateral luxation (33.3%). Most injuries (33.3%) presented during May. The most common form of treatment was follow-up only (39.4%), followed by extraction (29.3%) and root canal treatment (12.1%). The average follow-up period was 11 months. During the follow-up period, complications were observed in 4 teeth. Conclusions: The study results show that in the absence of acute symptoms, parents tend not to apply to a dental clinic for children’s injuries. This finding highlights the importance of informing the public about primary tooth injuries and their consequences. PMID:20922165

  13. Dimensions of impulsive behavior and treatment outcomes for adolescent smokers.

    PubMed

    Harris, Millie; Penfold, Robert B; Hawkins, Ariane; Maccombs, Jared; Wallace, Bryan; Reynolds, Brady

    2014-02-01

    Adolescent cigarette smoking rates remain a significant public health concern, and as a result there is a continued need to understand factors that contribute to an adolescent's ability to reduce or quit smoking. Previous research suggests that impulsive behavior may be associated with treatment outcomes for smoking. The current research (N = 81) explored 3 dimensions of impulsive behavior as predictors of treatment response from a social-cognitive type program for adolescent smokers (i.e., Not On Tobacco; N-O-T). Measures included laboratory assessments of delay discounting, sustained attention, and behavioral disinhibition. A self-report measure of impulsivity was also included. Adolescent smokers who had better sustained attention were more likely to reduce or quit smoking by the end of treatment. No other measures of impulsivity were significantly associated with treatment response. From these findings, an adolescent smoker's ability to sustain attention appears to be an important behavioral attribute to consider when implementing smoking cessation programs such as N-O-T.

  14. Criminal justice outcomes after engagement in outpatient substance abuse treatment.

    PubMed

    Garnick, Deborah W; Horgan, Constance M; Acevedo, Andrea; Lee, Margaret T; Panas, Lee; Ritter, Grant A; Dunigan, Robert; Bidorini, Alfred; Campbell, Kevin; Haberlin, Karin; Huber, Alice; Lambert-Wacey, Dawn; Leeper, Tracy; Reynolds, Mark; Wright, David

    2014-03-01

    The relationship between engagement in outpatient treatment facilities in the public sector and subsequent arrest is examined for clients in Connecticut, New York, Oklahoma and Washington. Engagement is defined as receiving another treatment service within 14 days of beginning a new episode of specialty treatment and at least two additional services within the next 30 days. Data are from 2008 and survival analysis modeling is used. Survival analyses express the effects of model covariates in terms of "hazard ratios," which reflect a change in the likelihood of outcome because of the covariate. Engaged clients had a significantly lower hazard of any arrest than non-engaged in all four states. In NY and OK, engaged clients also had a lower hazard of arrest for substance-related crimes. In CT, NY, and OK engaged clients had a lower hazard of arrest for violent crime. Clients in facilities with higher engagement rates had a lower hazard of any arrest in NY and OK. Engaging clients in outpatient treatment is a promising approach to decrease their subsequent criminal justice involvement. © 2014.

  15. Prediction of Treatment Outcomes After Global Endometrial Ablation

    PubMed Central

    El-Nashar, Sherif A.; Hopkins, Matthew R.; Creedon, Douglas J.; St. Sauver, Jennifer L.; Weaver, Amy L.; McGree, Michaela E.; Cliby, William A.; Famuyide, Abimbola O.

    2010-01-01

    Objective To report rates of amenorrhea and treatment failure after global endometrial ablation and to estimate the association between patient factors and these outcomes by developing and validating prediction models. Methods From January 1998 through December 2005, 816 women underwent global endometrial ablation with either a thermal balloon ablation or radiofrequency ablation device; 455 were included in a population-derived cohort (for model development), and 361 were included in a referral-derived cohort (for model validation). Amenorrhea was defined as cessation of bleeding from immediately after ablation through at least 12 months after the procedure. Treatment failure was defined as hysterectomy or re-ablation for patients with bleeding or pain. Logistic and Cox proportional hazard regression models were used in model development and validation of potential predictors of outcomes. Results The amenorrhea rate was 23% (95% confidence interval [CI], 19%–28%) and the 5-year cumulative failure rate was 16% (95% CI, 10%–20%). Predictors of amenorrhea were age 45 years or older (adjusted odds ratio [aOR], 2.6; 95% CI, 1.6–4.3); uterine length less than 9 cm (aOR, 1.8; 95% CI, 1.1–3.1); endometrial thickness less than 4 mm (aOR, 2.7; 95% CI, 1.2–6.3); and use of radiofrequency ablation instead of thermal balloon ablation (aOR, 2.8; 95% CI, 1.7–4.9). Predictors of treatment failure included age younger than 45 years (adjusted hazard ratio [aHR], 2.6; 95% CI, 1.3–5.1); parity of 5 or greater (aHR, 6.0; 95% CI, 2.5–14.8); prior tubal ligation (aHR, 2.2; 95% CI, 1.2–4.0); and history of dysmenorrhea (aHR, 3.7; 95% CI, 1.6–8.5). After global endometrial ablation, 23 women (5.1%; 95% CI, 3.2%–7.5%) had pelvic pain, 3 (0.7%; 95% CI, 0.1%–1.9%) were pregnant, and none (95% CI, 0%–0.8%) had endometrial cancer. Conclusion Population-derived rates and predictors of treatment outcomes after global endometrial ablation may help physicians offer optimal

  16. Acupuncture for the Treatment of Chronic Pain in the Military Population: Factors Associated With Treatment Outcomes.

    PubMed

    Plunkett, Anthony; Beltran, Thomas; Haley, Chelsey; Kurihara, Connie; McCoart, Amy; Chen, Louis; Wilkinson, Indy; Cohen, Steven P

    2017-10-01

    Acupuncture is characterized as an alternative or complementary medicine with a low complication rate and minimal side effects. There is a lack of robust evidence that shows acupuncture is an effective treatment for chronic pain. The purpose of this study was to determine which (if any) characteristics can predict successful response to acupuncture in chronic pain patients treated at military treatment facilities. Data from 222 patients who received treatment for a chronic pain condition were collected from 2 medical centers. The patients underwent at least 4 acupuncture treatments and had an average pain score of 4 or higher on a 0- to 10-point numerical rating scale or visual analog scale in the week before treatment initiation. A successful outcome was defined to be a 2-point or greater reduction on the numerical rating scale or visual analog scale 12 weeks postinitial treatment. The overall treatment success rate was 42.3%. Multivariate logistic regression found a higher baseline pain rating and the use of stimulation needles to be associated with a positive outcome (odds ratio [OR]=1.26; 95% confidence interval [CI], 1.03-1.55; P=0.02 and OR=2.73; 95% CI, 1.39-5.32; P=0.03, respectively). Only the presence of one or more psychological comorbidities was found to be associated with treatment failure (OR=0.67; 95% CI, 0.49-0.92; P=0.01). The use of electrical stimulation and higher baseline pain score were associated with a positive treatment outcome, while the presence of a psychological comorbidity diminished the likelihood of treatment success. Practitioners should consider using electrical stimulation more frequently, and addressing psychopathology before or concurrent to treatment, when initiating acupuncture.

  17. Osteosarcoma of the spine: surgical treatment and outcomes

    PubMed Central

    2013-01-01

    Background The goal of this study was to determine whether there are correlations between various options of surgical treatment and long-term outcome for spinal osteosarcoma. Methods This was a retrospective review of 16 patients with spinal osteosarcoma, who underwent surgical treatment from 1999 to 2010. Seven patients were given total en bloc spondylectomy (TES), while nine received piecemeal resection (there were seven cases of total piecemeal spondylectomy, one of sagittal resection, and one of vertebrectomy). The outcome and prognosis of the patients were evaluated, grouped by surgical treatment. Results All 16 cases were followed for an average of 42.4 months. At follow-up, all patients noted that pain had eased or had gradually disappeared. Three months after surgery, eight patients (50.0%) had improved 1 to 2 grades in their neurological status, based on Frankel scoring. Six (37.5%) patients experienced local recurrence of the tumor, nine (56.3%) had metastases, and five (31.3%) died of the disease. Of the six patients who received a wide or marginal en bloc resection, none developed local recurrence or died from the disease. Conversely, of the ten patients who received intralesional or contaminated resections, six (60%) relapsed and five (50%) died from the disease. Conclusions TES, with a wide margin, should be planned for patients with osteosarcoma of the cervical and thoracolumbar spine, whenever possible. When the patients are not candidates for en bloc resection, total piecemeal spondylectomy is an appropriate choice for osteosarcoma in the mobile spine. PMID:23597053

  18. Outcomes of Patients in Long-Term Opioid Maintenance Treatment.

    PubMed

    Zippel-Schultz, Bettina; Specka, Michael; Cimander, Konrad; Eschenhagen, Thomas; Gölz, Jörg; Maryschok, Markus; Nowak, Manfred; Poehlke, Thomas; Stöver, Heino; Helms, Thomas M; Scherbaum, Norbert

    2016-09-18

    Despite the importance of duration of opioid maintenance treatment (OMT), only few studies have reported outcomes of long-term OMT. To describe outcomes of long-term (> 5 years) OMT patients with respect to substance use, physical and mental health, and socioeconomic characteristics. Patients (n = 160) were recruited from 15 OMT offices in different regions of Germany. Data were collected using a structured interview at baseline, and clinical recordings, including urine drug screenings, during 12 monhts follow-up. Patients had a mean age of 44 years. During follow-up, 23% of patients showed indications of an alcohol problem. Cannabis was used by 56%, often frequently. Heroin was used by 28%, mostly infrequently. Three quarters of patients either had a non-substance related mental disorder (48.1%, most frequently affective and anxiety disorders) or somatic diagnosis (61.3%, frequently hepatitis C, HIV, or cardiovascular diseases), or both. Unemployment rate was 43.1% at baseline (27% for patients without comorbidity) and remained generally stable during follow-up. No arrests or incarcerations were recorded. During follow-up, 2.5% of patients prematurely terminated OMT, 2.5% regularly completed OMT. The sample as a whole was characterized by stable living conditions, high unemployment, low illicit opiate use, and a high retention rate. Continuation of OMT could enable further treatment of comorbidity and prevent resumption of a drug-dominated lifestyle. But it may well be asked how within the context of OMT further improvements can be achieved, especially with regard to further decrease of alcohol use and the treatment of depression.

  19. Prediction of Class III treatment outcomes through orthodontic data mining.

    PubMed

    Auconi, Pietro; Scazzocchio, Marco; Cozza, Paola; McNamara, James A; Franchi, Lorenzo

    2015-06-01

    To determine whether it is possible to predict Class III treatment outcomes on the basis of a model derived from a combination of computational analyses derived from complexity science, such as fuzzy clustering repartition and network analysis. Cephalometric data of 54 Class III patients (32 females, 22 males) taken before (T1, mean age 8.2 ± 1.6 years) and after (T2, mean age 14.6 ± 1.8 years) early rapid maxillary expansion and facemask therapy followed by fixed appliances were analysed. Patients were classified at T1 on the basis of high membership grade into three main dentoskeletal fuzzy cluster phenotypes: hyperdivergent (HD), hypermandibular (HM), and balanced (Bal) phenotypes. The prevalence rate of successful and unsuccessful cases at T2 was calculated for the three clusters and compared by means of Fisher's exact test corrected for multiple testing (Holm-Bonferroni method). Unsuccessful cases were 9 out of 54 patients (16.7%). Once patients were framed into their cluster membership, the individualized pre-treatment prediction of unsuccessful cases was largely differentiated: HD and HM patients showed a significantly greater prevalence rate of unsuccessful cases than Bal patients (0% in Bal cluster, 28.6% in HM cluster, and 33.3% in HD cluster). Network analysis captured some noticeable interdependencies of Class III patients, showing a more connected interactive structure of cephalometric data sets in HM and HD patients compared with Bal patients. The results were confirmed after minimizing the geometrical connections between cephalometric variables in the model. Fuzzy clustering repartition can be usefully used to estimate an individualized risk of unsuccessful treatment outcome in Class III patients. © The Author 2014. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  20. Treatment approaches and outcomes in childhood supracondylar humerus fractures.

    PubMed

    Uçar, B Y; Demirtaş, A; Uçar, D E

    2012-07-01

    Being one of the most frequent elbow fractures during childhood, supracondylar humerus fractures require rapid diagnosis and treatment, as they may be associated with significant neurovascular and functional problems. QUESTIONS AND PURPOSES: To evaluate demographic and clinical features, and treatment outcomes of the patients with supracondylar humerus fractures who underwent open reduction+minimal osteosynthesis or closed reduction+percutaneous wiring. Forty patients (30 boys + 10 girls) between 2 and 13 years of age who were operated on with the diagnosis of supracondylar humerus fracture, between August 2003 and December 2006, were included. Open reduction+minimal osteosynthesis (n=34) and closed reduction+percutaneous wiring (n=6) were performed. The fractures were classified according to the Gartland classification and outcomes were assessed according to Flynn's criteria. All patients (mean age, 7.35 years; range, 2-13 years) had closed fractures (28 left and 12 right). Seven (17.5%) and 33 (82.5%) patients had Gartland type II and III fractures respectively. Three patients had flexion-type and 37 patients had extension-type fractures. Based on Flynn's criteria, cosmetic results were excellent in 37 (92.5%) patients and good in 3 (7.5%) patients, and functional results were excellent in 36 (90%) patients, good in 3 (7.5%) patients, and poor in 1 (2.5%) patient. A surgical success rate of 97.5% was noted. No significant difference was found between wire configurations (p > 0.05). Treatment of supracondylar humerus fractures in children should be patient-specific based on factors such as patient's age, soft tissue conditions and deformity status.

  1. Reduced RANKL expression impedes osteoclast activation and tooth eruption in alendronate-treated rats.

    PubMed

    Bradaschia-Correa, Vivian; Moreira, Mariana M; Arana-Chavez, Victor E

    2013-07-01

    The creation of the eruption pathway requires the resorption of the occlusal alveolar bone by osteoclasts and signaling events between bone and dental follicle are necessary. The aim of the present study has been to evaluate the effect of alendronate on osteoclastogenesis and the expression of the regulator proteins of osteoclast activation, namely RANK, RANKL and OPG, in the bone that covers the first molar germ. Newborn Wistar rats were treated daily with 2.5 mg/kg alendronate for 4, 8, 14, 21 and 28 days, whereas controls received sterile saline solution. At the time points cited, maxillae were fixed, decalcified and processed for light and electron microscopic analysis. TRAP histochemistry was performed on semi-serial sections and the osteoclasts in the occlusal half of the bony crypt surface were counted. TUNEL analysis was carried out on paraffin sections. The occlusal bone that covers the upper first molar was removed in additional 4- and 8-day-old alendronate-treated and control rats in which the expression of RANK, RANKL and OPG was analyzed by SDS-polyacrylamide gel electrophoresis and Western blotting. TRAP-positive osteoclasts were more numerous in the alendronate group at all time points, despite their unactivated phenotype and the presence of apoptotic cells. RANKL expression in the alendronate specimens was inhibited at all time points, unlike in controls. Our findings indicate that the expression of RANKL in the occlusal portion of the bony crypt is unrelated to osteoclast recruitment and differentiation but is crucial to their activation during the creation of the eruption pathway.

  2. Bioabsorbable bone plates enabled with local, sustained delivery of alendronate for bone regeneration.

    PubMed

    Hur, Woojune; Park, Min; Lee, Jae Yeon; Kim, Myung Hun; Lee, Seung Ho; Park, Chun Gwon; Kim, Se-Na; Min, Hye Sook; Min, Hye Jeong; Chai, Jin Ho; Lee, Sang Jeong; Kim, Sukwha; Choi, Tae Hyun; Choy, Young Bin

    2016-01-28

    We prepared a bone plate enabled with the local, sustained release of alendronate, which is a drug known to inhibit osteoclast-mediated bone resorption and also expedite the bone-remodeling activity of osteoblasts. For this, we coated a bone plate already in clinical use (PLT-1031, Inion, Finland) with a blend of alendronate and a biocompatible polymer, azidobenzoic acid-modified chitosan (i.e., Az-CH) photo-crosslinked by UV irradiation. As we performed the in vitro drug release study, the drug was released from the coating at an average rate of 4.03μg/day for 63days in a sustained manner. To examine the effect on bone regeneration, the plate was fixed on an 8mm cranial critical size defect in living rats and the newly formed bone volume was quantitatively evaluated by micro-computed tomography (micro-CT) at scheduled times over 8weeks. At week 8, the group implanted with the plate enabled with sustained delivery of alendronate showed a significantly higher volume of newly formed bone (52.78±6.84%) than the groups implanted with the plates without drug (23.6±3.81%) (p<0.05). The plate enabled with alendronate delivery also exhibited good biocompatibility on H&E staining, which was comparable to the Inion plate already in clinical use. Therefore, we suggest that a bone plate enabled with local, sustained delivery of alendronate can be a promising system with the combined functionality of bone fixation and its expedited repair. Copyright © 2015 Elsevier B.V. All rights reserved.

  3. Treatment Outcomes in Undocumented Hispanic Immigrants with HIV Infection

    PubMed Central

    Poon, Kenneth K.; Dang, Bich N.; Davila, Jessica A.; Hartman, Christine; Giordano, Thomas P.

    2013-01-01

    Objective Little is known about the treatment outcomes of undocumented Hispanic immigrants with HIV infection. We sought to compare the treatment outcomes of undocumented and documented patients 12-months after entering HIV care. Methods We conducted a retrospective cohort study of antiretroviral-naive patients 18 years and older attending their first visit at Thomas Street Health Center in Houston, Texas, between 1/1/2003 and 6/30/2008. The study population of 1,620 HIV-infected adults included 186 undocumented Hispanic, 278 documented Hispanic, 986 Black, and 170 White patients. The main outcome measures were retention in care (quarter years with at least one completed HIV primary care provider visit) and HIV suppression (HIV RNA <400 copies/mL), both measured 12-months after entering HIV care. Results Undocumented Hispanic patients had lower median initial CD4 cell count (132 cells/mm3) than documented Hispanic patients (166 cells/mm3; P = 0.186), Black patients (226 cells/mm3; P<0.001), and White patients (264 cells/mm3; P = 0.001). However, once in care, undocumented Hispanic patients did as well or better than their documented counterparts. One year after entering HIV care, undocumented Hispanics achieved similar rates of retention in care and HIV suppression as documented Hispanic and White patients. Of note, black patients were significantly less likely to have optimal retention in care (adjusted odds ratio [aOR] 0.65, CI = 0.45–0.94) or achieve HIV suppression (aOR 0.32, CI = 0.17–0.61) than undocumented Hispanics. Conclusions Undocumented Hispanic persons with HIV infection enter care with more advanced disease than documented persons, suggesting testing and/or linkage to care efforts for this difficult-to-reach population need intensification. Once diagnosed, however, undocumented Hispanics have outcomes as good as or better than other racial/ethnic groups. Safety net providers for undocumented immigrants are vital for maintaining

  4. Treatment outcomes in undocumented Hispanic immigrants with HIV infection.

    PubMed

    Poon, Kenneth K; Dang, Bich N; Davila, Jessica A; Hartman, Christine; Giordano, Thomas P

    2013-01-01

    Little is known about the treatment outcomes of undocumented Hispanic immigrants with HIV infection. We sought to compare the treatment outcomes of undocumented and documented patients 12-months after entering HIV care. We conducted a retrospective cohort study of antiretroviral-naive patients 18 years and older attending their first visit at Thomas Street Health Center in Houston, Texas, between 1/1/2003 and 6/30/2008. The study population of 1,620 HIV-infected adults included 186 undocumented Hispanic, 278 documented Hispanic, 986 Black, and 170 White patients. The main outcome measures were retention in care (quarter years with at least one completed HIV primary care provider visit) and HIV suppression (HIV RNA <400 copies/mL), both measured 12-months after entering HIV care. Undocumented Hispanic patients had lower median initial CD4 cell count (132 cells/mm(3)) than documented Hispanic patients (166 cells/mm(3); P = 0.186), Black patients (226 cells/mm(3); P<0.001), and White patients (264 cells/mm(3); P = 0.001). However, once in care, undocumented Hispanic patients did as well or better than their documented counterparts. One year after entering HIV care, undocumented Hispanics achieved similar rates of retention in care and HIV suppression as documented Hispanic and White patients. Of note, black patients were significantly less likely to have optimal retention in care (adjusted odds ratio [aOR] 0.65, CI = 0.45-0.94) or achieve HIV suppression (aOR 0.32, CI = 0.17-0.61) than undocumented Hispanics. Undocumented Hispanic persons with HIV infection enter care with more advanced disease than documented persons, suggesting testing and/or linkage to care efforts for this difficult-to-reach population need intensification. Once diagnosed, however, undocumented Hispanics have outcomes as good as or better than other racial/ethnic groups. Safety net providers for undocumented immigrants are vital for maintaining individual and public health.

  5. The Relationship between Pre-Treatment Clinical Profile and Treatment Outcome in an Integrated Stuttering Program

    ERIC Educational Resources Information Center

    Huinck, Wendy J.; Langevin, Marilyn; Kully, Deborah; Graamans, Kees; Peters, Herman F. M.; Hulstijn, Wouter

    2006-01-01

    A procedure for subtyping individuals who stutter and its relationship to treatment outcome is explored. Twenty-five adult participants of the Comprehensive Stuttering Program (CSP) were classified according to: (1) stuttering severity and (2) severity of negative emotions and cognitions associated with their speech problem. Speech characteristics…

  6. Predictors and Moderators of Treatment Outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I)

    ERIC Educational Resources Information Center

    Garcia, Abbe Marrs; Sapyta, Jeffrey J.; Moore, Phoebe S.; Freeman, Jennifer B.; Franklin, Martin E.; March, John S.; Foa, Edna B.

    2010-01-01

    Objective: To identify predictors and moderators of outcome in the first Pediatric OCD Treatment Study (POTS I) among youth (N = 112) randomly assigned to sertraline, cognitive behavioral therapy (CBT), both sertraline and CBT (COMB), or a pill placebo. Method: Potential baseline predictors and moderators were identified by literature review. The…

  7. Modified Therapeutic Community Treatment for Offenders with MICA Disorders: Antisocial Personality Disorder and Treatment Outcomes

    ERIC Educational Resources Information Center

    McKendrick, Karen; Sullivan, Christopher; Banks, Steven; Sacks, Stanley

    2006-01-01

    Treatment outcomes 1 year after release from prison were compared for two subgroups of male inmates with co-occurring serious mental illness and chemical abuse (MICA) disorders, those with a diagnosis for Antisocial Personality Disorder (APD), and those without a diagnosis of APD. The foundation study had randomly assigned inmates to either…

  8. The Association Between Treatment Frequency and Treatment Outcome for Cardiovascular Surgeries

    PubMed Central

    Choi, Ji Suk; Park, Choon Seon; Kim, Myunghwa; Kim, Myo Jeong; Lee, Kun Sei; Sim, Sung Bo; Chee, Hyun Keun; Park, Nam Hee; Park, Sung Min

    2016-01-01

    Background This study analyzed the association between the volume of heart surgeries and treatment outcomes for hospitals in the last five years. Methods Hospitals that perform heart surgeries were chosen throughout Korea as subjects using from the Health Insurance Review and Assessment Service. The treatment outcome of the heart surgeries was defined as the mortality within 30 postoperative days, while the annual volume of the surgeries was categorized. Logistic regression was used as the statistical analysis method, and the impacts of the variables on the heart surgery treatment outcomes were then analyzed. Results The chance of death of patients who received surgery in a hospital that performed 50 or more surgeries annually was noticeably lower than patients receiving operations from hospitals that performed fewer than 50 surgeries annually, indicating that the chance of death decreases as the annual volume of heart surgeries in the hospital increases. In particular, the mortality rate in hospitals that performed more than 200 surgeries annually was less than half of that in hospitals that performed 49 or fewer surgeries annually. Conclusion These results indicate that accumulation of a certain level of heart surgery experience is critical in improving or maintaining the quality of heart surgeries. In order to improve the treatment outcomes of small hospitals, a support policy must be implemented that allows for cooperation with experienced professionals. PMID:28035294

  9. Predictors and Moderators of Treatment Outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I)

    ERIC Educational Resources Information Center

    Garcia, Abbe Marrs; Sapyta, Jeffrey J.; Moore, Phoebe S.; Freeman, Jennifer B.; Franklin, Martin E.; March, John S.; Foa, Edna B.

    2010-01-01

    Objective: To identify predictors and moderators of outcome in the first Pediatric OCD Treatment Study (POTS I) among youth (N = 112) randomly assigned to sertraline, cognitive behavioral therapy (CBT), both sertraline and CBT (COMB), or a pill placebo. Method: Potential baseline predictors and moderators were identified by literature review. The…

  10. Prevalence and Treatment Outcome of Cervicitis of Unknown Etiology

    PubMed Central

    Taylor, Stephanie N.; Lensing, Shelly; Schwebke, Jane; Lillis, Rebecca; Mena, Leandro A.; Nelson, Anita L.; Rinaldi, Anne; Saylor, Lisa; McNeil, Linda; Lee, Jeannette Y.

    2013-01-01

    Background Mucopurulent cervicitis (MPC) is a clinical syndrome characterized by mucopurulent discharge from the cervix and other signs of inflammation. This was a phase III, multi-center study designed to evaluate the effectiveness of placebo versus empiric antibiotic treatment for clinical cure of MPC of unknown etiology at 2 months follow-up. Unfortunately, enrollment was terminated due to low accrual of women with cervicitis of unknown etiology but important prevalence and outcome data were obtained. Methods Five hundred seventy-seven women were screened for MPC. Women with MPC were randomized to the treatment or placebo arm of the study and the two arms were evaluated based upon the etiology, clinical cure rates, adverse events (AEs) and rates of pelvic inflammatory disease (PID). Results One hundred thirty-one or 23% (131/577) of screened women were found to have MPC. Eighty-seven were enrolled and randomized. After excluding women with sexually transmitted infections and other exclusions, 61% (53/87) had cervicitis of unknown etiology. The overall clinical failure rate was 30% (10/33) and the clinical cure rate was only 24% (8/33). Rates were not significantly different between the arms. There were 24 gastrointestinal (GI) AEs in the treatment arm compared to 1 AE in the placebo arm. Conclusion Over half of the cases of MPC were of unknown etiology. Clinical cure rates for the placebo and treatment arms were extremely low, with most women concluding the study with a partial response. Gastrointestinal AEs were higher in the treatment arm. PMID:23588127

  11. Brain Metastasis from Colorectal Cancer: Predictors and Treatment Outcomes.

    PubMed

    Nozawa, Hiroaki; Ishihara, Soichiro; Kawai, Kazushige; Sasaki, Kazuhito; Murono, Koji; Otani, Kensuke; Nishikawa, Takeshi; Tanaka, Toshiaki; Kiyomatsu, Tomomichi; Hata, Keisuke; Watanabe, Toshiaki

    2017-07-13

    Difficulties are associated with the management of brain metastasis (BM), which portends a poor prognosis in the treatment of colorectal cancer (CRC). The aim of the present study was to identify risk factors for BM in CRC and evaluate the outcomes of various treatment modalities. We retrospectively reviewed data on a total of 2,238 patients with primary CRC who underwent surgical resection at our hospital between 1999 and 2014. Predictive factors for BM and prognostic factors after the diagnosis of BM were examined by univariate and multivariate analyses using Cox proportional hazards models. Three patients (0.1%) had BM at the initial diagnosis, and 23 patients (1.2%) developed metachronous BM during the median follow-up period of 44.6 months. Lung and bone metastases were identified as independent predictive factors for BM. Median survival after the diagnosis of BM was 7.4 months. Stereotactic radiosurgery, administered to 41% of the patients with BM, was associated with a better postdiagnostic survival. CRC patients with metastasis to the lung or bone were at a higher risk of BM. Because the survival is still limited, it is crucial to determine the treatment strategy in consideration of the characteristics of each therapy and quality of life in CRC patients with BM. © 2017 S. Karger AG, Basel.

  12. Frequency and outcome of treatment in polycystic ovaries related infertility

    PubMed Central

    Arain, Farzana; Arif, Nesreen; Halepota, Hafeez

    2015-01-01

    Background: Infertility is defined as inability of couple to conceive after one year of unprotected intercourse. The prevalence of infertility in Pakistan is 21.9%. The most common cause of medically treatable infertility is polycystic ovarian syndrome (PCO). This study was conducted to see the frequency and outcome of treatment in PCOs related infertility in infertile couples coming to Mohammad Medical College Hospital, Mirpurkhas, Sindh. Methods: This prospective observational study was conducted at Muhammad Medical College for three years from 2005 to 2008. Total 1289 infertile couples were included in this study. Result: The frequency of PCOs in female related infertility was 38.5%. Other causes of female infertility were in the frequency of 44% pelvic inflammatory disease, 12.3% endometriosis, 2.9% hyperprolactenemia, and 1.35% hypothyroidism. Patients with PCOS were given different treatment modalities. One hundred fifty patients with PCO were given ovulation induction with clomephene citrate and out of them 109 (72%) conceived. Sixty three women were given combination of clomephene citrate and Metformin. Out of them 50 (79%) conceived. Five patients were given gonadotrophins, Out of them 2 (40%) patients conceived. Five patients had laparoscopic drilling out of them 3 (60%) conceived. Conclusion: In contrast to the literature review Polycystic Ovarian Syndrome turned out to be the second most common cause of female related infertility. But as the international literature shows it had very good out come after medical and /or surgical treatment. PMID:26150870

  13. Could training executive function improve treatment outcomes for eating disorders?

    PubMed

    Juarascio, Adrienne S; Manasse, Stephanie M; Espel, Hallie M; Kerrigan, Stephanie G; Forman, Evan M

    2015-07-01

    Current gold standard treatments for eating disorders (EDs) lack satisfactory efficacy, and traditional psychological treatments do not directly address executive functioning deficits underpinning ED pathology. The goal of this paper is to explore the potential for enhancing ED treatment outcomes by improving executive functioning deficits that have been demonstrated to underlie eating pathology. To achieve our objective, we (1) review existing evidence for executive functioning deficits that underpin EDs and consider the extent to which these deficits could be targeted in neurocognitive training programs, (2) present the evidence for the one ED neurocognitive training program well-studied to date (Cognitive Remediation Therapy), (3) discuss the utility of neurocognitive training programs that have been developed for other psychiatric disorders with similar deficits, and (4) provide suggestions for the future development and research of neurocognitive training programs for EDs. Despite the fact that the body of empirical work on neurocognitive training programs for eating disorders is very small, we conclude that their potential is high given the combined evidence for the role of deficits in executive functioning in EDs, the initial promise of Cognitive Remediation Training, and the success in treating related conditions with neurocognitive training. Based on the evidence to date, it appears that the development and empirical evaluation of neurocognitive training programs for EDs is warranted.

  14. Classical Galactosaemia in Ireland: incidence, complications and outcomes of treatment.

    PubMed

    Coss, K P; Doran, P P; Owoeye, C; Codd, M B; Hamid, N; Mayne, P D; Crushell, E; Knerr, I; Monavari, A A; Treacy, E P

    2013-01-01

    Newborn screening for the inborn error of metabolism, classical galactosaemia prevents life-threatening complications in the neonatal period. It does not however influence the development of long-term complications and the complex pathophysiology of this rare disease remains poorly understood. The objective of this study was to report the development of a healthcare database (using Distiller Version 2.1) to review the epidemiology of classical galactosaemia in Ireland since initiation of newborn screening in 1972 and the long-term clinical outcomes of all patients attending the National Centre for Inherited Metabolic Disorders (NCIMD). Since 1982, the average live birth incidence rate of classical galactosaemia in the total Irish population was approximately 1:16,476 births. This reflects a high incidence in the Irish 'Traveller' population, with an estimated birth incidence of 1:33,917 in the non-Traveller Irish population. Despite early initiation of treatment (dietary galactose restriction), the long-term outcomes of classical galactosaemia in the Irish patient population are poor; 30.6 % of patients ≥ 6 yrs have IQs <70, 49.6 % of patients ≥ 2.5 yrs have speech or language impairments and 91.2 % of females ≥ 13 yrs suffer from hypergonadotrophic hypogonadism (HH) possibly leading to decreased fertility. These findings are consistent with the international experience. This emphasizes the requirement for continued clinical research in this complex disorder.

  15. Galeazzi lesions in children and adolescents: treatment and outcome.

    PubMed

    Eberl, Robert; Singer, Georg; Schalamon, Johannes; Petnehazy, Thomas; Hoellwarth, Michael E

    2008-07-01

    A Galeazzi fracture is defined as a fracture of the radius associated with dislocation of the distal radioulnar joint. Treatment in children and adolescents is usually possible with closed reduction and casting. The objective of this retrospectively designed study was to describe all Galeazzi lesions treated at our department during a 3-year period. One hundred ninety-eight patients with displaced fractures of the radius alone or both bones of the forearm were reviewed. In 26 (13%) cases, a Galeazzi lesion was found and these patients formed the study group. Outcome was assessed using the Gartland-Werley score. Eight of 26 (31%) fractures were recognized initially and classified as a Galeazzi lesion. Casting after fracture reduction was possible in 22 patients. Thirteen patients were treated with immobilization in a below-elbow cast and nine with an above-elbow cast. Four patients were treated operatively. The results were excellent in 23 cases and good in three cases. In cases of distal forearm fractures, a possible Galeazzi lesion should be considered. However, proper reduction of the radius with concomitant reduction of the distal radioulnar joint and cast immobilization provides good to excellent outcome even if the Galeazzi lesion is primarily not recognized. Level IV, therapeutic study.

  16. Galeazzi Lesions in Children and Adolescents: Treatment and Outcome

    PubMed Central

    Singer, Georg; Schalamon, Johannes; Petnehazy, Thomas; Hoellwarth, Michael E.

    2008-01-01

    A Galeazzi fracture is defined as a fracture of the radius associated with dislocation of the distal radioulnar joint. Treatment in children and adolescents is usually possible with closed reduction and casting. The objective of this retrospectively designed study was to describe all Galeazzi lesions treated at our department during a 3-year period. One hundred ninety-eight patients with displaced fractures of the radius alone or both bones of the forearm were reviewed. In 26 (13%) cases, a Galeazzi lesion was found and these patients formed the study group. Outcome was assessed using the Gartland-Werley score. Eight of 26 (31%) fractures were recognized initially and classified as a Galeazzi lesion. Casting after fracture reduction was possible in 22 patients. Thirteen patients were treated with immobilization in a below-elbow cast and nine with an above-elbow cast. Four patients were treated operatively. The results were excellent in 23 cases and good in three cases. In cases of distal forearm fractures, a possible Galeazzi lesion should be considered. However, proper reduction of the radius with concomitant reduction of the distal radioulnar joint and cast immobilization provides good to excellent outcome even if the Galeazzi lesion is primarily not recognized. Level of Evidence: Level IV, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18443894

  17. Patient-reported outcomes in stuttering treatment: conceptual framework.

    PubMed

    Franic, Duska M; Bothe, Anne K

    2008-04-01

    Evaluation of: Yaruss JS, Quesal RW. Overall Assessment of the Speaker's Experience of Stuttering (OASES): documenting multiple outcomes in stuttering treatment. J. Fluency Disord. 31(2), 90-115 (2006) [1] . These authors presented the first complete instrument intended to measure the impact of stuttering in adults who stutter (Overall Assessment of the Speaker's Experience of Stuttering; [OASES]). OASES is a 100-item self-report metric with four sections: general information, reactions to stuttering, communication in daily situations and quality of life. Its conceptual framework includes historic views of the influence of emotional and cognitive variables on stuttering; the WHO's International Classification of Impairments, Disabilities and Handicaps (ICIDH); and the WHO's International Classification of Functioning, Disability and Health (ICF). However, both this conceptual framework and the psychometric data presented to support the OASES are problematic in ways that clinicians and researchers in areas well-beyond stuttering may find informative as they consider their own applications.

  18. Staff attitudes and the associations with treatment organisation, clinical practices and outcomes in opioid maintenance treatment

    PubMed Central

    2010-01-01

    Background In opioid maintenance treatment (OMT) there are documented treatment differences both between countries and between OMT programmes. Some of these differences have been associated with staff attitudes. The aim of this study was to 1) assess if there were differences in staff attitudes within a national OMT programme, and 2) investigate the associations of staff attitudes with treatment organisation, clinical practices and outcomes. Methods This study was a cross-sectional multicentre study. Norwegian OMT staff (n = 140) were invited to participate in this study in 2007 using an instrument measuring attitudes towards OMT. The OMT programme comprised 14 regional centres. Data describing treatment organisation, clinical practices and patient outcomes in these centres were extracted from the annual OMT programme assessment 2007. Centres were divided into three groups based upon mean attitudinal scores and labelled; "rehabilitation-oriented", "harm reduction-oriented" and "intermediate" centres. Results All invited staff (n = 140) participated. Staff attitudes differed between the centres. "Rehabilitation-oriented" centres had smaller caseloads, more frequent urine drug screening and increased case management (interdisciplinary meetings). In addition these centres had less drug use and more social rehabilitation among their patients in terms of long-term living arrangements, unemployment, and social security benefits as main income. "Intermediate" centres had the lowest treatment termination rate. Conclusions This study identified marked variations in staff attitudes between the regional centres within a national OMT programme. These variations were associated with measurable differences in caseload, intensity of case management and patient outcomes. PMID:20604924

  19. Outcomes associated with timing of maintenance treatment for COPD exacerbation.

    PubMed

    Dalal, Anand A; Shah, Manan B; D'Souza, Anna O; Dhamane, Amol D; Crater, Glenn D

    2012-09-01

    To examine the impact of timing of maintenance treatment initiation (early vs delayed) on risk of future exacerbations and costs in chronic obstructive pulmonary disease (COPD) patients. Retrospective cohort design using data (January 1, 2003, through June 30, 2009) from a large, US-based integrated pharmacy and medical claims database. Administrative claims from January 1, 2003, through June 30, 2009, were used. Methotrexate (MTx)-naïve patients (aged >40 years) with at least 1 COPD-related hospitalization/emergency department (ED) visit were included (discharge date was index date). Patients initiating MTx within the first 30 days and 31 to 180 days post-index were classified into early and delayed cohorts, respectively. Clinical and economic outcomes related to COPD exacerbations were assessed for 1 year post-index and compared between cohorts using regression models controlling for baseline characteristics. The incremental effect on outcomes of every 30-day delay in MTx initiation up to 6 months after the index event was also assessed. The majority of the 3806 patients (78.6%) received early MTx. A significantly higher proportion of patients in the delayed cohort had a COPD-related hospitalization/ED visit compared with the early cohort (25.6% vs 18.0%; P <.001). After controlling for baseline differences, the delayed cohort had a 43% (P <.001) higher risk of a future COPD-related hospitalization/ED visit compared with the early cohort. Every 30-day delay was associated with 9% risk increase (P = .002). Treatment delay also increased COPD-related costs ($5012 vs $3585; P <.001). Early MTx initiation is associated with reduced risk of future COPD exacerbations and lower costs.

  20. Trauma in patients with temporomandibular disorders: frequency and treatment outcome.

    PubMed

    De Boever, J A; Keersmaekers, K

    1996-02-01

    Controversy exists on the aetiological importance and the effect of jaw macrotrauma (fractures excluded) on the occurrence of temporomandibular joint disorders (TMD). The purpose of this study was to assess the incidence of jaw injury in TMD patients and to compare the severity of the symptoms, the clinical characteristics and the treatment outcome in TMD patients with or without a history of trauma to the head and neck region directly linked to the onset of symptoms. The study sample included 400 consecutive TMD clinical patients. In 24.5% of patients the onset of the pain and dysfunction could be linked directly to the trauma, mainly whiplash accidents. No significant differences could be found between the two groups in daily recurrent headache, dizziness, neck pain, joint crepitation and pain in the joints. Maximal mouth opening was less than 20 mm in 14.3% of patients with a history of trauma and in 4.1% of those without such a history. According to the Helkimo dysfunction index (DI), more trauma than non-trauma TMD patients belonged to the severe dysfunction groups (DI 4 and 5) at first examination. The outcome of a conservative treatment procedure (counselling, occlusal splint, physiotherapy, occasionally occlusal therapy and non-steroidal anti-inflammation drugs was not different between the two groups at the 1 year evaluation. The degree of maximal opening was similar: less than 20 mm in 3.7% and 2.2% in trauma and non-trauma patients respectively. Forty percent and 41% respectively were symptom free or had DI = 1. The results suggest that external trauma to the joint or to the jaw in general is an important initiating factor in the aetiology of TMD but also that the prognosis is favourable.

  1. Treatment Outcomes of Patients With Tardive Dyskinesia and Chronic Schizophrenia

    PubMed Central

    Caroff, Stanley N.; Davis, Vicki G.; Miller, Del D.; Davis, Sonia M.; Rosenheck, Robert A.; McEvoy, Joseph P.; Campbell, E. Cabrina; Saltz, Bruce L.; Riggio, Silvana; Chakos, Miranda H.; Swartz, Marvin S.; Keefe, Richard S. E.; Stroup, T. Scott; Lieberman, Jeffrey A.

    2013-01-01

    Objective We compared the response to antipsychotic treatment between patients with and without tardive dyskinesia (TD) and examined the course of TD. Method This analysis compared 200 patients with DSM-IV–defined schizophrenia and TD and 997 patients without TD, all of whom were randomly assigned to receive one of 4 second-generation antipsychotics. The primary clinical outcome measure was time to all-cause treatment discontinuation, and the primary measure for evaluating the course of TD was change from baseline in Abnormal Involuntary Movement Scale (AIMS) score. Kaplan-Meier survival analysis and Cox proportional hazards regression models were used to compare treatment discontinuation between groups. Changes in Positive and Negative Syndrome Scale (PANSS) and neurocognitive scores were compared using mixed models and analysis of variance. Treatment differences between drugs in AIMS scores and all-cause discontinuation were examined for those with TD at baseline. Percentages of patients meeting criteria for TD postbase-line or showing changes in AIMS scores were evaluated with χ2 tests. Data were collected from January 2001 to December 2004. Results Time to treatment discontinuation for any cause was not significantly different between the TD and non-TD groups (χ21 =0.11, P = .743). Changes in PANSS scores were not significantly different (F1,974 = 0.82, P = .366), but patients with TD showed less improvement in neurocognitive scores (F1,359=6.53, P =.011). Among patients with TD, there were no significant differences between drugs in the decline in AIMS scores (F3,151 = 0.32, P = .811); 55% met criteria for TD at 2 consecutive visits postbaseline, 76% met criteria for TD at some or all postbaseline visits, 24% did not meet criteria for TD at any subsequent visit, 32% showed a ≥ 50% decrease in AIMS score, and 7% showed a ≥ 50% increase in AIMS score. Conclusions Schizophrenia patients with and without TD were similar in time to discontinuation of

  2. Alendronate binds to tooth root surfaces and inhibits progression of feline tooth resorption: a pilot proof-of-concept study.

    PubMed

    Mohn, Kenneth L; Jacks, Thomas M; Schleim, Klaus Dieter; Harvey, Colin E; Miller, Bonnie; Halley, Bruce; Feeney, William P; Hill, Susan L; Hickey, Gerry

    2009-01-01

    Tissue distribution, bioavailability, and efficacy of alendronate in preventing progression of resorption of teeth were evaluated in cats. [Butyl-4-14C-]-alendronate accumulates on subgingival tooth and alveolar bone surfaces adjacent to vascularized tissue resulting in concentration of the drug around tooth roots. Three cats were treated with a 0.03 mg/kg i.v. bolus of [butyl-4-14C-]-alendronate followed by blood, urine, and feces collection and euthanasia 24-hours later. Drug tissue distribution was accessed by autoradiography and sample combustion. To assess bioavailability, 12 cats were administered alendronate orally (3.0 or 9.0 mg/kg in water or 9.0 mg/kg in tuna water) and urine was collected for 24-hours. In these formulations, alendronate oral bioavailability in cats was approximately 3%. In addition, 10 cats with radiographic evidence of pre-existing tooth resorption (14 affected teeth) were treated with vehicle or 3.0 mg/kg alendronate per os once weekly for 22-weeks and, then, 9.0 mg/kg per os twice weekly for 27-weeks in a random, masked study. Radiographic area of resorption was measured and progression scored every 3 to 4-months. In placebo-treated cats, resorption progressed in five of six teeth (+ 97% average increase in area of resorption), whereas progression of resorption was seen in only three of eight affected teeth in alendronate-treated cats with a -22% average change (decrease) in area (P < 0.01 difference in number of teeth showing progression; P < 0.001 difference in area of resorption). Alendronate accumulated preferentially on subgingival tooth surfaces and adjacent alveolar bone and, at a dose of 9 mg/kg twice weekly, effectively slowed or arrested the progression of resorption.

  3. [Treatment and outcome of complications after free flap-plasty].

    PubMed

    Giunta, R; Geisweid, A; Lukas, B; Feller, A M

    2000-05-01

    Free tissue transplantation is a routine procedure in reconstructive surgery. Although a lot of free flap techniques have been described, the postoperative management of complications has gained only little interest. Nevertheless, complications of perfusion after free tissue transplantation are not rare and require a systematic approach. The aim of this study is to classify perfusion failures with a simple grading system prospectively on a large clinical series and to evaluate the results of treatment to improve management. In the past ten months, 70 consecutive free flaps have been performed. By the end of the operation, the operating surgeon gave a prognosis concerning the probability of a possible perfusion complication. Postoperative monitoring was done exclusively by clinical examination (colour, time for recapillarisation and bleeding after puncture). According to these parameters, arterial and venous insufficiencies have been classified into four grades. After recording type, time and treatment of a postoperative complication, the result of treatment was rated subjectively and a cause was noted when possible. The final result was classified either as total flap loss, partial flap loss or successful tissue transplantation. A total of 28 (40%) complications, which were treated with an average of 2.1 options, were recorded. The ratio between arterial and venous failure was 15:13. In 21 cases surgical intervention became necessary (intraoperative n = 12, postoperative n = 9). The arising complication was diagnosed correctly in nine cases by the operating surgeon. In ten cases, the cause of the complication remained unclear. In 18 cases, the complication was treated successfully without any flap loss. In six cases partial flap loss was observed and in four cases a total flap loss had to be accepted. Our results confirm that only few objective criteria for treatment options with perfusion failures after free tissue transplantation exist. Nevertheless, the

  4. Endovascular Treatment of Epistaxis: Indications, Management, and Outcome

    SciTech Connect

    Strach, Katharina; Schroeck, Andreas; Wilhelm, Kai; Greschus, Susanne; Tschampa, Henriette; Moehlenbruch, Markus; Naehle, Claas P.; Jakob, Mark; Gerstner, Andreas O. H.; Bootz, Friedrich; Schild, Hans H.; Urbach, Horst

    2011-12-15

    Objective: Epistaxis is a common clinical problem, and the majority of bleedings can be managed conservatively. However, due to extensive and sometimes life-threatening bleeding, further treatment, such as superselective embolization, may be required. We report our experience with endovascular treatment of life-threatening epistaxis. Methods: All patients presenting with excessive epistaxis, which received endovascular treatment at a German tertiary care facility between January 2001 and December 2009, were retrospectively identified. Demographic data, etiology, origin and clinical relevance of bleeding, interventional approach, therapy-associated complications, and outcome were assessed. Results: A total of 48 patients required 53 embolizations. Depending on the etiology of bleeding, patients were assigned to three groups: 1) idiopathic epistaxis (31/48), 2) traumatic or iatrogenic epistaxis (12/48), and 3) hereditary hemorrhagic telangiectasia (HHT) (5/48). Eleven of 48 patients required blood transfusions, and 9 of these 11 patients (82%) were termed clinically unstable. The sphenopalatine artery was embolized unilaterally in 10 of 53 (18.9%) and bilaterally in 41 of 53 (77.4%) procedures. During the same procedure, additional vessels were embolized in three patients (3/53; 5.7%). In 2 of 53(3.8%) cases, the internal carotid artery (ICA) was occluded. Long-term success rates of embolization were 29 of 31 (93.5%) for group 1 and 11 of 12 (91.7%) for group 2 patients. Embolization of patients with HHT offered at least a temporary relief in three of five (60%) cases. Two major complications (necrosis of nasal tip and transient hemiparesis) occurred after embolization. Conclusions: Endovascular treatment proves to be effective for prolonged and life-threatening epistaxis. It is easily repeatable if the first procedure is not successful and offers a good risk-benefit profile.

  5. Floating knee injuries: Results of treatment and outcomes.

    PubMed

    Nouraei, Mohammad Hadi; Hosseini, Alireza; Zarezadeh, Abolghasem; Zahiri, Mohammad

    2013-12-01

    Floating knee, referred to as ipsilateral fractures of the femur and tibia, is usually associated with several complications and mortality. This study was designed to present our experience with treatment of this injury throughout; age, sex, mechanism of injury, associated injuries, method and results of treatment, and complications of floating knee are discussed. This retrospective study was performed between January 2006 and December 2011. All patients with floating knee injuries who were admitted to the referral educational hospitals were included. The information about the 238 cases of floating knee injuries were gathered through the 254,620 trauma files and after excluding 18 patients who died within 6 months, the remaining files were studied and the target information was recorded. The most frequent age group was 20-29 years (44.5%). The floating knee injuries were more common in males (85.5%). Type (D) according to "the classification of Letts and Vincent" was observed in 38.9% cases. The most frequent mechanism of injury was car to motorcycles accidents (48.2%). The most common associated injury was pelvic fractures (86.8%). Open reduction and internal fixation was the common type of treatment (70%). The most common early and late complications were knee hemarthrosis in 31 cases (14%) and knee osteoarthritis in 30 cases (13.6%), respectively. Death during the 5 years follow up was due to circulatory disruption, followed by deep vein thrombosis (61%). There was a significant relation between the age and outcomes as it worsens with age (P-value < 0.05). This study revealed that the complication rate associated with floating knee injuries remained high, regardless of the used treatment regimen and surgeons should focus on reducing complications while treating it.

  6. Outcomes of two-phase orthodontic treatment of deepbite malocclusions.

    PubMed

    Franchi, Lorenzo; Baccetti, Tiziano; Giuntini, Veronica; Masucci, Caterina; Vangelisti, Andrea; Defraia, Efisio

    2011-11-01

    The objective of this prospective controlled study was to assess the outcomes of two-phase treatment of deepbite patients revaluated at the end of circumpubertal growth, 1 year after the end of a phase-2 treatment. A sample of 58 subjects with deepbite (mean age 9.7 years, overbite greater than 4.5 mm) was treated consecutively with a two-phase protocol. Lateral cephalograms were taken before treatment (T1), at the completion of phase 1 (T2), and 1 year after the completion of phase 2 with fixed appliances (T3, mean age 15.8 years). The T1-T2, T2-T3, and T1-T3 changes were compared with those of the 29 subjects (mean age at T1 = 9.1 years) with untreated deepbite (t-tests for independent samples). Prevalence rates for improved overbite during the T1-T3 interval and for corrected overbite at T3 were contrasted in the treated vs untreated groups (z tests on proportions). Overbite was reduced by 1.9 mm in the treated group as a result of overall treatment; this group also displayed a significant reduction in the interincisal angulation (-6.6°) due to a significant proclination of upper incisors (4.1°) and a significant increase in the projection of the lower incisors (2.0 mm). The average amount of deepbite correction 1 year into retention was modest, and it was mainly due to a significant proclination of the incisors. The prevalence rate of subjects with a corrected overbite in the treated sample at T3 (74%) was not significantly different from that of the untreated sample (52%).

  7. Patient Characteristics and Treatment Outcomes for African American, Hispanic, and White Adolescents in DATOS-A.

    ERIC Educational Resources Information Center

    Rounds-Bryant, Jennifer L.; Staab, Jennifer

    2001-01-01

    Compared background, pre-treatment characteristics, and post-treatment outcomes of African American, Hispanic, and white adolescent substance abusers participating in the Drug Abuse Treatment Outcome Studies for Adolescents (DATOS-A). Found that patients were similar with respect to basic pre-treatment demographics. Compared to white adolescents,…

  8. Use of Patient Self-Report Oral Health Outcome Measures in Assessment of Dental Treatment Outcomes

    PubMed Central

    Wright, Wanda G.; Jones, Judith A.; Spiro, Avron; Rich, Sharron E.; Kressin, Nancy R.

    2012-01-01

    Objective To assess the sensitivity of a newly developed brief measure of oral health-related quality of life (OQOL). Methods Self-assessed oral health and OQOL were measured in three groups of patients who had presented for either prophylaxis (n = 32), endodontic care (n = 15), or for a denture (n = 16) in a dental school setting before and after treatment. Main outcome measures included the single-item self-report of oral health (OH-1) and the 6- and 12-item versions of a new OQOL instrument. General linear modeling was used to compute means of self-reported oral health by treatment group. Results Of the 63 patients who completed the baseline questionnaire, 44 (70 percent) returned questionnaires after treatment. The sample averaged 43 ± 15 years, 48 percent male and 55 percent with some college education. Ethnic representation included 35 percent White, 33 percent Black, and 32 percent other – mostly Latino. The mean self-reported number of teeth was 20.6. In terms of sensitivity, significant differences were observed between the treatment groups on the items assessing being upset (P < 0.05), feeling depressed (P < 0.05), and uncomfortable about the appearance of teeth or dentures (P < 0.05). However, magnitude of change, as measured by an effect size, was characterized as minimal to small in the recall and endodontic groups and borderline moderate in the denture group. Conclusion The measure was sensitive to differences within groups, with a small to borderline magnitude of change. PMID:19054312

  9. Low Doses of Simvastatin Potentiate the Effect of Sodium Alendronate in Inhibiting Bone Resorption and Restore Microstructural and Mechanical Bone Properties in Glucocorticoid-Induced Osteoporosis.

    PubMed

    Sequetto, Priscila L; Gonçalves, Reggiani V; Pinto, Aloísio S; Oliveira, Maria G A; Maldonado, Izabel R S C; Oliveira, Tânia T; Novaes, Rômulo D

    2017-10-01

    By using an experimental model of dexamethasone-induced osteoporosis we investigated the effects of different therapeutic schemes combining sodium alendronate (SA) and simvastatin on bone mineral and protein composition, microstructural and mechanical remodeling. Wistar rats were randomized into eight groups: G1: non-osteoporotic; G2: osteoporotic; G3, G4, and G5: osteoporotic+SA (0.2, 0.4, and 0.8 mg/kg, respectively); G6, G7, and G8: osteoporotic+SA (0.2, 0.4, and 0.8 mg/kg, respectively)+simvastatin (0.4, 0.6, and 1 mg/kg, respectively). Osteoporosis was induced by dexamethasone (7 mg/kg, i.m.) once a week for 5 weeks. All treatments were administered for 8 weeks. Dexamethasone increased serum levels of alkaline phosphatase, calcium, phosphorus, and urea, especially in non-treated animals, which showed severe osteoporosis. Dexamethasone also induced bone microstructural fragility and reduced mechanical resistance, which were associated with a marked depletion in mineral mass, collagenous and non-collagenous protein levels in cortical and cancellous bone. Although SA has attenuated osteoporosis severity, the effectiveness of drug therapy was enhanced combining alendronate and simvastatin. The restoration in serum parameters, organic and inorganic bone mass, and mechanical behavior showed a dose-dependent effect that was potentially related to the complementary mechanisms by which each drug acts to induce bone anabolism, accelerating tissue repair.

  10. Pulmonary delivery of nanosized alendronate for decorporation of inhaled heavy metals: formulation development, characterization and gamma scintigraphic evaluation.

    PubMed

    Sultana, Shaheen; Bhatnagar, Aseem; Rawat, Harish; Nishad, Dhruv Kumar; Talegaonkar, Sushma; Ahmad, Farhan Jalees; Mittal, Gaurav

    2014-08-01

    Medical management of heavy metal toxicity including radioactive ones is the cause of concern because of their increased use in energy production, healthcare and mining. As inhalation is one of the primary routes for internalization, a formulation is needed to trap metal(s) at the portal of entry itself. Objective was to formulate and characterize a nanonized dry powder inhaler (DPI) formulation of alendronate sodium as potential inhalable antidote for chelating metal toxicants. In vitro binding studies of alendronate with respect to seven non-radioactive heavy metals were carried out using UV-spectroscopy and HPLC. Nanonizing of alendronate particles was achieved by antisolvent precipitation using Pluronic-F68 as stabilizer. Characterization was done with the help of SEM, TEM FT-IR, XRD, DSC, NMR spectroscopy and PSD studies. In vitro and in vivo pulmonary deposition studies were carried out using gamma scintigraphy, followed by a limited pharmacokinetic study in humans. In vitro binding studies confirmed the chelating action of alendronate. Anderson cascade impaction showed that nano-alendronate exhibited significantly higher respirable fraction (58.25 ± 1.32%) compared to the micronized form (28.7 ± 0.59%). Scintigraphy results showed significant increase in the alveolar deposition of drug post-nanonizing. Results strongly indicate the role of nano-alendronate DPI as potential inhalable antidote for neutralizing heavy metal toxicity, including radio-metal contamination.

  11. Purpose in Life Predicts Treatment Outcome Among Adult Cocaine Abusers in Treatment

    PubMed Central

    Martin, Rosemarie A.; MacKinnon, Selene; Johnson, Jennifer; Rohsenow, Damaris J.

    2010-01-01

    A sense of purpose in life has been positively associated with mental health and well-being and has been negatively associated with alcohol use in correlational and longitudinal studies, but has not been studied as a predictor of cocaine treatment outcome. This study examined pre-treatment purpose in life as a predictor of response to a 30-day residential substance use treatment program among 154 participants with cocaine dependence. Purpose in life was unrelated to cocaine or alcohol use during the 6 months pretreatment. After controlling for age, baseline use, and depressive symptoms, purpose in life significantly (p < .01) predicted relapse to any use of cocaine and to alcohol, and the number of days cocaine or alcohol was used in the six months after treatment. Findings suggest that increasing purpose in life may be an important aspect of treatment among cocaine dependent patients. PMID:21129893

  12. Inositol Treatment and ART Outcomes in Women with PCOS.

    PubMed

    Garg, Deepika; Tal, Reshef

    2016-01-01

    Polycystic ovary syndrome (PCOS) affects 5-10% of women in reproductive age and is characterized by oligo/amenorrhea, androgen excess, insulin resistance, and typical polycystic ovarian morphology. It is the most common cause of infertility secondary to ovulatory dysfunction. The underlying etiology is still unknown but is believed to be multifactorial. Insulin-sensitizing compounds such as inositol, a B-complex vitamin, and its stereoisomers (myo-inositol and D-chiro-inositol) have been studied as an effective treatment of PCOS. Administration of inositol in PCOS has been shown to improve not only the metabolic and hormonal parameters but also ovarian function and the response to assisted-reproductive technology (ART). Accumulating evidence suggests that it is also capable of improving folliculogenesis and embryo quality and increasing the mature oocyte yield following ovarian stimulation for ART in women with PCOS. In the current review, we collate the evidence and summarize our current knowledge on ovarian stimulation and ART outcomes following inositol treatment in women with PCOS undergoing in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI).

  13. Randomization inference for treatment effects on a binary outcome.

    PubMed

    Rigdon, Joseph; Hudgens, Michael G

    2015-03-15

    Two methods are developed for constructing randomization-based confidence sets for the average effect of a treatment on a binary outcome. The methods are nonparametric and require no assumptions about random sampling from a larger population. Both of the resulting 1 - α confidence sets are exact in the sense that the probability of containing the true treatment effect is at least 1 - α. Both types of confidence sets are also guaranteed to have width no greater than one. In contrast, a previously proposed asymptotic confidence interval is not exact and may have width greater than 1. The first approach combines Bonferroni-adjusted prediction sets for the attributable effects in the treated and untreated. The second method entails inverting a permutation test. Simulations are presented comparing the two randomization-based confidence sets with the asymptotic interval as well as the standard Wald confidence interval and a commonly used exact interval for the difference in binomial proportions. Results show for small to moderate sample sizes that the permutation confidence set attains the narrowest width on average among the methods that maintain nominal coverage. Extensions that allow for stratifying on categorical baseline covariates are also discussed. Copyright © 2014 John Wiley & Sons, Ltd.

  14. Long term outcome of Aldosteronism after target treatments

    PubMed Central

    Wu, Vin-Cent; Wang, Shuo-Meng; Chang, Chia-Hui; Hu, Ya-Hui; Lin, Lian-Yu; Lin, Yen-Hung; Chueh, Shih-Chieh Jeff; Chen, Likwang; Wu, Kwan-Dun

    2016-01-01

    There exists a great knowledge gap in terms of long-term effects of various surgical and pharmacological treatments on outcomes among primary aldosteronism (PA) patients. Using a validated algorithm, we extracted longitudinal data for all PA patients diagnosed in 1997–2010 and treated in the Taiwan National Health Insurance. We identified 3362 PA patients for whom the mean length of follow-up was 5.75 years. PA has higher major cardiovascular events (MACE) than essential hypertension (23.3% vs 19.3%, p = 0.015). Results from the Cox model suggest a strong effect of adrenalectomy on lowering mortality (HR = 0.23 with residual hypertension and 0.21 with resolved hypertension). While need for receptor antagonist (MRA) MRA after diagnosis suggests that a defined daily dose (DDD) of MRA between 12.5 and 50 mg may alleviate risk of death in a U-shape pattern. A specificity test identified patients who has aldosterone producing adenoma (HR = 0.50, p = 0.005) also confirmed adrenalectomy attenuated all-cause mortality. Adrenalectomy decreases long-term all-cause mortality independently from PA cure from hypertension. Prescription corresponding to a DDD between 12.5 and 50 mg may decrease mortality for patients needing MRA. It calls for more attention on early diagnosis, early treatment and prescription of appropriate dosage of MRA for PA patients. PMID:27586402

  15. Outcomes of Cataract Surgery Following Treatment for Retinoblastoma

    PubMed Central

    Kim, Hyeong Min; Lee, Byung Joo; Kim, Jeong Hun

    2017-01-01

    Purpose To evaluate the long-term visual outcomes and complications of cataract surgery in eyes previously treated for retinoblastoma. Methods We reviewed the medical records of patients who underwent cataract extraction and intraocular lens implantation at Seoul National University Children's Hospital for a secondary cataract that developed after retinoblastoma treatment. Results During the period between 1990 and 2014, 208 eyes of 147 patients received eye-salvaging treatment (radiotherapy, chemotherapy, and local therapy) for retinoblastoma at Seoul National University Children's Hospital. Among these eyes, a secondary cataract was detected in 17 eyes of 14 patients, and five eyes of five patients underwent cataract surgery. The median age of cataract formation was 97 months (range, 38 to 153 months). The medial interval between the diagnosis of retinoblastoma and cataract formation was 79 months (range, 29 to 140 months). All patients received posterior chamber intraocular lens insertion after irrigation and aspiration of the lens through a scleral tunnel incision. Anterior vitrectomy and posterior capsulotomy were performed in two eyes and a laser capsulotomy was subsequently performed in one eye. No intraoperative and postoperative complications occurred. The median follow-up after surgery was 36 months (range, 14 to 47 months). The final best corrected visual acuities were improved in all five eyes. No intraocular tumor recurrences or metastases occurred. Conclusions After retinoblastoma regression, cataract extraction in our series was not associated with tumor recurrence or metastasis. Visual improvement was noted in every patient. PMID:28243024

  16. Delay in diagnosis of retinoblastoma: risk factors and treatment outcome

    PubMed Central

    Goddard, A.; Kingston, J.; Hungerford, J.

    1999-01-01

    BACKGROUND—Delay in diagnosis of retinoblastoma causes considerable parental distress; however, the primary healthcare professional (PHP) may have difficulty detecting the most common presenting symptom—leucocoria. Alternatively, the PHP may not appreciate that retinoblastoma is the pathology underlying more common ocular symptoms in infants and young children.
METHOD—The parents of 100 recently diagnosed patients with retinoblastoma were interviewed to establish the extent of diagnostic delay, ascertain any associated risk factors, and to determine whether or not delay influenced treatment outcome.
RESULTS—Although nearly 50% of patients were referred to an ophthalmologist within 1 week of first consulting a PHP, one quarter waited more than 8 weeks. There was a significantly increased risk of diagnostic de