Biomedical subjects

S L Silverman

Publications and source records attributed to S L Silverman.

At least 19 recordsLinked to original sources

PubMed2006

Effectiveness of bisphosphonates on nonvertebral and hip fractures in the first year of therapy: the risedronate and alendronate (REAL) cohort study.

INTRODUCTION: Randomized clinical trials have shown that risedronate and alendronate reduce fractures among women with osteoporosis. The aim of this observational study was to observe, in clinical practice, the incidence of hip and nonvertebral fractures among women in the year following initiation of once-a-week dosing of either risedronate or alendronate. METHODS: Using records of health service utilization from July 2002 through September 2004, we created two cohorts: women (ages 65 and over) receiving risedronate (n = 12,215) or alendronate (n = 21,615). Cox proportional hazard modeling was used to compare the annual incidence of nonvertebral fractures and of hip fractures between cohorts, adjusting for potential differences in risk factors for fractures. RESULTS: There were 507 nonvertebral fractures and 109 hip fractures. Through one year of therapy, the incidence of nonvertebral fractures in the risedronate cohort (2.0%) was 18% lower (95% CI 2% - 32%) than in the alendronate cohort (2.3%). The incidence of hip fractures in the risedronate cohort (0.4%) was 43% lower (95% CI 13% - 63%) than in the alendronate cohort (0.6%). These results were consistent across a number of sensitivity analyses. CONCLUSION: Patients receiving risedronate have lower rates of hip and nonvertebral fractures during their first year of therapy than patients receiving alendronate.

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PubMed2006

The role of socioeconomic status on hip fracture.

INTRODUCTION: The impact of socioeconomic status-income and acculturation-on hip fracture is not well understood. We studied 116,919 fractures among 8,144,469 people in California. Greater income and English fluency predict lower fracture incidence. Lower income and immigrant populations are at increased risk for hip fracture and require intervention. Race/ethnicity is a major determinant of hip fracture risk. Although socioeconomic status (e.g., income and acculturation) is often associated with race/ethnicity, its impact on hip fracture incidence is less well understood. METHODS: We carried out a retrospective, population-based, study of persons with hip fractures in California, 1996 to 2000, compared to census estimates by zip code. We performed Poisson regression analyses to calculate hip fracture incident rate ratios for gender, age, race/ethnicity, income, language (percent non-English speakers)-a proxy for acculturation-and living in rural areas. RESULTS: During the 5-year period, 116,919 fractures occurred among 8,144,469 persons (2.87 fractures/1,000 persons per year). Higher income predicted lower hip fracture incidence. Persons in the highest decile of estimated income had an incident rate ratio (IRR) of 0.79 (95% confidence interval (CI) 0.77 to 0.82) compared with those in the lowest decile. Greater IRR of hip fracture was predicted for persons living in areas with a greater percent of non-English speakers (IRR 1.004, 95% CI 1.003 to 1.005). CONCLUSIONS: Low income and language fluency are predictors of greater hip fracture incidence. Although much attention is given to the aging of the "baby boomers", low income and immigrant populations are at increased risk for hip fracture and require intervention.

Acculturation↗

PubMed2005

Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study.

BACKGROUND: Reducing bisphosphonate dosing frequency may improve suboptimal adherence to treatment and therefore therapeutic outcomes in postmenopausal osteoporosis. Once-monthly oral ibandronate has been developed to overcome this problem. OBJECTIVE: To confirm the 1 year results and provide more extensive safety and tolerability information for once-monthly dosing by a 2 year analysis. METHODS: MOBILE, a randomised, phase III, non-inferiority study, compared the efficacy and safety of once-monthly ibandronate with daily ibandronate, which has previously been shown to reduce vertebral fracture risk in comparison with placebo. RESULTS: 1609 postmenopausal women were randomised. Substantial increases in lumbar spine bone mineral density (BMD) were seen in all treatment arms: 5.0%, 5.3%, 5.6%, and 6.6% in the daily and once-monthly groups (50 + 50 mg, 100 mg, and 150 mg), respectively. It was confirmed that all once-monthly regimens were at least as effective as daily treatment, and in addition, 150 mg was found to be better (p<0.001). Substantial increases in proximal femur (total hip, femoral neck, trochanter) BMD were seen; 150 mg produced the most pronounced effect (p<0.05 versus daily treatment). Independent of the regimen, most participants (70.5-93.5%) achieved increases above baseline in lumbar spine or total hip BMD, or both. Pronounced decreases in the biochemical marker of bone resorption, sCTX, observed in all arms after 3 months, were maintained throughout. The 150 mg regimen consistently produced greater increases in BMD and sCTX suppression than the 100 mg and daily regimens. Ibandronate was well tolerated, with a similar incidence of adverse events across groups. CONCLUSIONS: Once-monthly oral ibandronate is at least as effective and well tolerated as daily treatment. Once-monthly administration may be more convenient for patients and improve therapeutic adherence, thereby optimising outcomes.

Administration, Oral↗

PubMed2004

Association of severe vertebral fractures with reduced quality of life: reduction in the incidence of severe vertebral fractures by teriparatide.

OBJECTIVE: The association between vertebral fracture severity and health-related quality of life (HRQOL) was investigated in a subset of patients in the Fracture Prevention Trial. We sought to determine whether vertebral fracture severity was associated with HRQOL scores, and if so, to determine the effects of teriparatide (recombinant human parathyroid hormone 1-34) on vertebral fracture grades that most strongly impact HRQOL in postmenopausal women with osteoporosis. METHODS: Vertebral fracture severity was assessed by the visual semiquantitative (SQ) method. A subset of 444 patients with a baseline radiograph completed the Osteoporosis Assessment Questionnaire. Baseline HRQOL scores were modeled as a function of maximum baseline vertebral fracture grade, while controlling for age, bone mineral density, body mass index, and back pain. RESULTS: The effect of baseline vertebral fracture grade on baseline HRQOL was statistically significant, while interactions between vertebral fracture grade and the other variables were not statistically significant. SQ grade 3 (SQ3) vertebral fractures were associated with a significantly lower overall HRQOL score and with significantly lower physical function, symptoms, and emotional status dimension scores. After a median of 19 months of therapy, new or worsening SQ3 vertebral fractures occurred in 21 of 448 patients (4.7%) in the placebo group compared with 3 of 444 patients (0.7%) in the 20 mug/day teriparatide group. The risk of developing a new or worsened SQ3 vertebral fracture was reduced by 86% (P < 0.001) in patients treated with 20 mug/day teriparatide. CONCLUSION: Compared with prevalent fractures of lesser severity, SQ3 vertebral fractures were associated with reduced HRQOL. Teriparatide treatment significantly reduced the risk of new or worsening SQ3 vertebral fractures. These findings suggest, but do not directly demonstrate, a benefit of teriparatide on HRQOL.

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PubMed2002

The analgesic role of calcitonin following osteoporotic fracture.

Osteoporosis is a systemic skeletal condition characterized by decreased bone strength with consequent increased susceptibility to bone fracture. Fragility fractures in osteoporosis are often painful and result in loss of quality of life and disability. Salmon calcitonin (SCT) is a natural hormone that may assist in the management of osteoporotic patients following fracture by reducing fracture risk and decreasing pain. SCT is an antiresorptive agent which has been shown to reduce the risk of vertebral fractures (by 36%) in postmenopausal women with osteoporosis and previous fractures, with a safety profile comparable to placebo over long-term use. Clinical evidence suggests that SCT (with either subcutaneous and intranasal delivery) is an analgesic for the acute pain following osteoporotic fracture. Pain relief with SCT occurs after 1 week or less of treatment. Associated with this pain relief, vertebral fracture patients receiving SCT have been observed to have earlier mobilization compared with those receiving a placebo. Both preclinical and clinical data suggest a central analgesic effect for SCT. The mechanism(s) by which SCT induces pain relief has (have) not been conclusively shown. Neither a direct receptor-mediated action nor an indirect endorphin-mediated effect can be ruled out.

Analgesics↗

PubMed2001

Risk of new vertebral fracture in the year following a fracture.

CONTEXT: Vertebral fractures significantly increase lifetime risk of future fractures, but risk of further vertebral fractures in the period immediately following a vertebral fracture has not been evaluated. OBJECTIVE: To determine the incidence of further vertebral fracture in the year following a vertebral fracture. DESIGN AND SETTING: Analysis of data from 4 large 3-year osteoporosis treatment trials conducted at 373 study centers in North America, Europe, Australia, and New Zealand from November 1993 to April 1998. SUBJECTS: Postmenopausal women who had been randomized to a placebo group and for whom vertebral fracture status was known at entry (n = 2725). MAIN OUTCOME MEASURE: Occurrence of radiographically identified vertebral fracture during the year following an incident vertebral fracture. RESULTS: Subjects were a mean age of 74 years and had a mean of 28 years since menopause. The cumulative incidence of new vertebral fractures in the first year was 6.6%. Presence of 1 or more vertebral fractures at baseline increased risk of sustaining a vertebral fracture by 5-fold during the initial year of the study compared with the incidence in subjects without prevalent vertebral fractures at baseline (relative risk [RR], 5.1; 95% confidence interval [CI], 3.1-8.4; P<.001). Among the 381 participants who developed an incident vertebral fracture, the incidence of a new vertebral fracture in the subsequent year was 19.2% (95% CI, 13.6%-24.8%). This risk was also increased in the presence of prevalent vertebral fractures (RR, 9.3; 95% CI, 1.2-71.6; P =.03). CONCLUSION: Our data indicate that women who develop a vertebral fracture are at substantial risk for additional fracture within the next year.

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PubMed2001

The relationship of health-related quality of life to prevalent and incident vertebral fractures in postmenopausal women with osteoporosis: results from the Multiple Outcomes of Raloxifene Evaluation Study.

OBJECTIVE: To examine the effect of both prevalent and incident vertebral fractures on health-related quality of life (HRQOL) in postmenopausal women with osteoporosis and to characterize the effect of prevalent vertebral fractures on HRQOL with respect to number, location, severity, and adjacency. METHODS: Participants were a subset of women (n = 1,395, mean age 68.5 years) from the Multiple Outcomes of Raloxifene Evaluation trial who had low bone mineral density and/or prevalent vertebral fractures. Vertebral fractures were measured by radiography at baseline, 2 years, and 3 years. HRQOL was assessed using the Osteoporosis Assessment Questionnaire (OPAQ), a validated disease-targeted instrument, at baseline and annually for 3 years. RESULTS: Both prevalent and incident radiographic vertebral fractures were associated with decreased HRQOL. At baseline, women with a prevalent vertebral fracture had significantly lower OPAQ scores on physical function, emotional status, clinical symptoms, and overall HRQOL compared with women without a prevalent fracture (all P < 0.01). HRQOL scores were lower with each subsequent fracture. The effect of prevalent vertebral fracture was dependent on the location within the spine and was strongest in the lumbar region (L1-L4). Incident vertebral fractures significantly decreased OPAQ scores on physical function, emotional status, clinical symptoms, and overall HRQOL (all P < 0.001). CONCLUSION: Our findings demonstrate the importance of treating postmenopausal women who have prevalent vertebral fractures to prevent further decreases in HRQOL associated with subsequent incident vertebral fracture.

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PubMed2001

Tolerability of risedronate in postmenopausal women intolerant of alendronate.

Bisphosphonates are effective treatments for osteoporosis, but some have been associated with upper gastrointestinal intolerance. This randomized, double-blind study assessed the upper gastrointestinal tolerability of risedronate in postmenopausal women who had discontinued alendronate treatment because of upper gastrointestinal adverse events. Sixty-six women who had previously discontinued treatment with alendronate 10 mg/day because of upper gastrointestinal symptoms received placebo (N=31) or risedronate 5 mg (N=35) daily for 3 months. The primary outcome was the rate of discontinuation due to upper gastrointestinal adverse events: 5/31 (16.1%) in the placebo group, and 4/35 (11.4%) in the risedronate group. Discontinuation rates were also similar in the two treatment groups among subgroups of patients with a history of gastrointestinal disorder, prior use of acid suppression drugs, and concomitant use of NSAIDs. The overall incidence of upper gastrointestinal events was comparable between the placebo (19.4%) and risedronate (20.0%) groups. Overall, risedronate 5 mg/day for 3 months was as well tolerated as placebo in patients who could not tolerate alendronate 10 mg. These results are consistent with, and complement those from previous studies showing that risedronate 5 mg has a gastrointestinal tolerability similar to that of placebo.

Alendronate↗

PubMed2001

Calcitonin.

Calcitonin reduces the risk of vertebral fracture in postmenopausal women with osteoporosis. Calcitonin produces small increments in the bone mass of the spine and modestly reduces bone turnover in women with osteoporosis. No significant effect on nonvertebral fractures has been observed. Calcitonin may have analgesic benefit.

Administration, Intranasal↗

PubMed2000

Deterioration in quality of life following hip fracture: a prospective study.

To examine longitudinal change in health-related quality of life (HRQoL) following hip fracture in elderly subjects, 32 patients with hip fractures and 29 sex-matched non-fracture control subjects (mean +/- SD age 82 +/- 8 and 86 +/- 6 years respectively) were enrolled in a prospective, case-control study. Fracture subjects completed a generic questionnaire, Short Form 36 (SF-36), and a disease-targeted measure, the revised Osteoporosis Assessment Questionnaire (OPAQ2), on two separate occasions, within 1 week of fracture and 12-15 weeks after fracture. Controls completed both questionnaires on two occasions 12 weeks apart. SF-36 scores were significantly correlated with OPAQ2 in comparable domains of Physical Function (r = 0.76), General Health (r = 0.70) and Mental Health/Tension (r=0.86). Control subjects had stable scores with the OPAQ2 and SF-36. At 3 months after fracture there was a significant reduction in HRQoL in the SF-36 domains Physical Function (-51%), Vitality (-24%) and Social Function (-26%) and in the OPAQ2 domains Physical Function (-20%), Social Activity (-49%) and General Health (-24%). Hip fracture patients thus had a lower baseline HRQoL and experienced a significant deterioration in HRQoL after hip fracture on both the SF-36 and OPAQ2. HRQoL should be part of a comprehensive assessment of the costs of osteoporosis including fracture-associated morbidity.

Aged↗

PubMed1998

Quality of life in osteoporosis: reliability, consistency, and validity of the Osteoporosis Assessment Questionnaire.

OBJECTIVE: To determine the reliability, consistency, and clinical utility of the Osteoporosis Assessment Questionnaire (OPAQ), an AIMS2 based self-assessment questionnaire. METHODS: Reliability of individual questions, scales, and domains were evaluated in 40 subjects by test-retest and intraclass correlation coefficients and internal consistency by Cronbach's alpha. Construct validity was evaluated by disease state. The relationships between domains and scales were modeled by confirmatory factor analysis. RESULTS: Mean kappa (79 questions) and intraclass correlation (18 health scales) coefficients were 0.58+/-0.16 (mean+/-SD) and 0.82+/-0.07, respectively. Internal consistency was greater than 0.8 in all but 3 scales. Construct validity was confirmed. Patients with hip fracture recorded lower OPAQ scores than patients with vertebral fracture. Correlation and confirmatory factor analyses grouped the 18 health scales into 7 domains. CONCLUSION: These findings suggest that OPAQ is a reliable, consistent, and valid instrument capable of distinguishing hierarchy of functional loss in disease states in osteoporosis.

Aged↗

PubMed1997

Nasal calcitonin.

Nasal calcitonin is a newly approved treatment for established osteoporosis that increases lumbar spine bone mass, is safe, and well tolerated. Fracture efficacy data is not yet available, although preliminary results are promising. The dose for established osteoporosis is 200 IU. The dose for prevention of postmenopausal osteoporosis has not been established. Nasal calcitonin may be analgesic to bone and may be of benefit in glucocorticoid-induced vertebral osteoporosis. Nasal spray calcitonin may be of benefit to the symptomatic patient with acute vertebral fracture, the complex patient, or the patient with established osteoporosis who is intolerant of bisphosphonates or estrogen.

Administration, Intranasal↗

PubMed1997

Effect of bone density information on decisions about hormone replacement therapy: a randomized trial.

OBJECTIVE: To determine the effect of bone density information on a woman's decision about hormone replacement therapy (HRT). METHODS: One hundred forty women were assigned randomly to receive either educational information about osteoporosis and a voucher for a bone mineral density test 12 months later or the same educational information plus an immediate dual-energy x-ray absorptiometry test for bone mineral density. Women in both groups were offered prescription for HRT. RESULTS: Of the 93 women who received a bone mineral density test, 63.4% elected HRT and filled their prescription, compared with only 20.0% of the 43 women who did not have a bone mineral density test (P < .01). Women who were classified as osteopenic (between -1 and -2.5 standard deviations [SDs] of the young normal bone mineral density) or osteoporotic (more than 2.5 SDs below young normals) were more likely to choose HRT (69.4%) than were women whose bone mineral density was in the normal range (51.6%) (above -1 SD of the young normal bone mineral density value). CONCLUSIONS: A bone mineral density test, regardless of the result, had a significant effect on women's decisions to accept HRT. Within the group having the test, women with lower bone mineral density were more likely to choose HRT.

Absorptiometry, Photon↗

PubMed1997

Calcitonin.

Nasal calcitonin is a newly approved treatment for established osteoporosis. Nasal calcitonin is safe, preventative, and may increase bone mass in the lumbar spine. Fracture efficacy data are not yet available, although preliminary results are promising. The dose of nasal calcitonin for the treatment of established osteoporosis is 200 IU daily. The dose for prevention of postmenopausal osteoporosis has not yet been established. Nasal calcitonin may be analgesic to bone and of benefit in glucocorticoid-induced osteoporosis.

Administration, Intranasal↗

PubMed1997

Fractures attributable to osteoporosis: report from the National Osteoporosis Foundation.

To assess the cost-effectiveness of interventions to prevent osteoporosis, it is necessary to estimate total health care expenditures for the treatment of osteoporotic fractures. Resources utilized for the treatment of many diseases can be estimated from secondary databases using relevant diagnosis codes, but such codes do not indicate which fractures are osteoporotic in nature. Therefore, a panel of experts was convened to make judgments about the probabilities that fractures of different types might be related to osteoporosis according to patient age, gender, and race. A three-round Delphi process was applied to estimate the proportion of fractures related to osteoporosis (i.e., the osteoporosis attribution probabilities) in 72 categories comprised of four specific fracture types (hip, spine, forearm, all other sites combined) stratified by three age groups (45-64 years, 65-84 years, 85 years and older), three racial groups (white, black, all others), and both genders (female, male). It was estimated that at least 90% of all hip and spine fractures among elderly white women should be attributed to osteoporosis. Much smaller proportions of the other fractures were attributed to osteoporosis. Regardless of fracture type, attribution probabilities were less for men than women and generally less for non-whites than whites. These probabilities will be used to estimate the total direct medical costs associated with osteoporosis-related fractures in the United States.

Aged↗

PubMed1997

Quality of life measurement in osteoporosis.

Quality of life measurement may be helpful in randomized clinical trials in osteoporosis to assess therapeutic tradeoffs and compare effects of different interventions. Quality of life measures include generic measures, disease targeted measures, and performance based measures. Disease targeted measures increase the coverage of domains that are of particular importance to the patient with established osteoporosis. Several disease targeted measures are currently available. These measures show discriminant validity, but data on longitudinal responsiveness and validity in randomized clinical trials are not yet available.

Humans↗

PubMed1996

Comparison of sulfasalazine and placebo in the treatment of ankylosing spondylitis. A Department of Veterans Affairs Cooperative Study.

OBJECTIVE: To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective for the treatment of active ankylosing spondylitis (AS) that is not controlled with nonsteroidal antiinflammatory drug therapy. METHODS: Two hundred sixty-four patients with AS were recruited from 15 clinics, randomized (double-blind) to SSZ or placebo treatment, and followed up for 36 weeks. Treatment response was based on morning stiffness, back pain, and physician and patient global assessments. RESULTS: While longitudinal analysis revealed a trend favoring SSZ in the middle of treatment, no difference was seen at the end of treatment. Response rates were 38.2% for SSZ and 36.1% for placebo (P = 0.73). The Westergren erythrocyte sedimentation rate declined more with SSZ treatment than with placebo (P < 0.0001). AS patients with associated peripheral arthritis showed improvement that favored SSZ (P = 0.02). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints. CONCLUSION: SSZ at a dosage of 2,000 mg/day does not seem to be more effective than placebo in the treatment of AS patients with chronic, longstanding disease. SSZ is well tolerated and may be more effective than placebo in the treatment of AS patients with peripheral joint involvement. This effect is more pronounced in treatment of the peripheral arthritis in this subgroup of AS patients.

Adult↗

PubMed1996

Comparison of sulfasalazine and placebo in the treatment of psoriatic arthritis. A Department of Veterans Affairs Cooperative Study.

OBJECTIVE: To determine whether sulfasalazine (SSZ) at a dosage of 2,000 mg/day is effective for the treatment of active psoriatic arthritis (PsA) resistant to nonsteroidal antiinflammatory drug therapy. METHODS: Two hundred twenty-one patients with PsA were recruited from 15 clinics, randomized (double-blind) to SSZ or placebo treatment, and followed up for 36 weeks. Treatment response was based on joint pain/ tenderness and swelling scores and physician and patient global assessments. RESULTS: Longitudinal analysis revealed a trend favoring SSZ treatment (P = 0.13). At the end of treatment, response rates were 57.8% for SSZ compared with 44.6% for placebo (P = 0.05). The Westergren erythrocyte sedimentation rate declined more in the PsA patients taking SSZ than in those taking placebo (P < 0.0001). Adverse reactions were fewer than expected and were mainly due to nonspecific gastrointestinal complaints, including dyspepsia, nausea, vomiting, and diarrhea. CONCLUSION: SSZ at a dosage of 2,000 mg/day is well tolerated and may be more effective than placebo in the treatment of patients with PsA.

Adult↗