Biomedical subjects

Stuart L Silverman

Publications and source records attributed to Stuart L Silverman.

12 recordsLinked to original sources

PubMed2007

Prevalence of depressive symptoms in postmenopausal women with low bone mineral density and/or prevalent vertebral fracture: results from the Multiple Outcomes of Raloxifene Evaluation (MORE) study.

OBJECTIVE: To examine the prevalence of depressive symptoms in a cross-sectional study of postmenopausal women with osteoporosis with and without prevalent vertebral fracture. METHODS: Participants were a subset of English-speaking women (n = 3798, mean age 66.7 yrs) from the Multiple Outcomes of Raloxifene Evaluation trial, who had low bone mineral density (BMD) and/or prevalent vertebral fractures. Vertebral fractures were measured at baseline by radiography using a semiquantitative technique. Depressive symptoms were assessed at baseline using the Geriatric Depression Scale (GDS), a valid and reliable scale for depression screening in elderly patients. Women were considered as probably depressed if > or = 6 symptoms of depression were reported. RESULTS: Postmenopausal women with prevalent vertebral fracture reported more depressive symptoms as assessed by the GDS than women without prevalent vertebral fracture (1.54 vs 1.26; p = 0.001). There was an absolute increase of 2.5% (p = 0.008) in the prevalence of probable depression (GDS score > or = 6) in women with prevalent fracture compared to those without prevalent fracture. The prevalence of probable depression was 4.1% among women without prevalent vertebral fracture and 6.6% in women with a prevalent vertebral fracture. The prevalence of probable depression was 3-fold higher in women with at least 3 prevalent vertebral fractures compared to women without prevalent fracture (12.8% vs 4.1%; p < 0.001). CONCLUSION: Postmenopausal women with prevalent vertebral fractures had greater prevalence of depressive symptoms and probable depression as assessed by the GDS than women without vertebral fracture with low BMD. The dual diagnosis of depression and osteoporosis may mean worse health outcomes. Patients with prevalent vertebral fractures may be considered not only for interventions that address fracture risk reduction, but also for psychosocial interventions that address depressive symptoms.

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PubMed2006

Selecting patients for osteoporosis therapy.

There is a global need to identify individuals at risk for osteoporotic fracture so that those at high risk can be treated and unnecessary treatment for those at low risk can be avoided. Bone mineral density (BMD) information is not sufficient to identify patients at high risk; approximately half of patients in the community with fractures do not have osteoporosis by the 1994 World Health Organization BMD criteria. Furthermore, BMD information is not easily accessible worldwide. The use of clinical risk factors with or without BMD information will improve our ability to identify patients at high risk for fracture. These risk factors can be integrated to predict a 10-year absolute risk or probability of fracture. Intervention thresholds based on absolute risk will be defined regionally based on each nation's ability and willingness to pay.

Age Factors↗

PubMed2006

An evaluation of patient preferences for osteoporosis medication attributes: results from the PREFER-US study.

OBJECTIVE: To evaluate preferences for eight medication attributes that women may consider when evaluating prescription osteoporosis medications. RESEARCH DESIGN AND METHODS: The eligible sample consisted of women aged 50 years or older who responded to the 2003 or 2004 Internet-based National Health and Wellness Survey as being diagnosed with osteoporosis, considering themselves at risk, or having a family history of osteoporosis. In this Internet survey (the PREFER survey), respondents were asked to: (1) force-rank order the eight attributes from one to eight according to their preferences and (2) separately rate the importance of each attribute on a Likert-type scale from 1 (extremely unimportant) to 7 (extremely important). RESULTS: We collected 999 responses across 3 days from a sample of 3368 women and stopped compiling responses after achieving sample size targets. Drug effectiveness (e.g., ability to reduce the risk of fractures) was force ranked as the No. 1 preferred osteoporosis medication attribute by 37% of the sample. Side effects were force ranked as the No. 1 preferred medication attribute by 36% of the sample. Dosing frequency, dosing procedure, and formulation (i.e., how the drug is taken) were each force ranked as No. 1 by 2% or less of the sample. Drug effectiveness had the highest percentage of 'extremely important' responses (59%) followed by drug interactions (53%). Drug effectiveness was the highest-rated attribute (mean [S.D.] = 6.1 [1.6], median = 7), while dosing frequency was the lowest-rated attribute (mean [S.D.] = 4.7 [1.8], median = 5). CONCLUSIONS: In our sample of women with a diagnosis of osteoporosis or at risk for osteoporosis, drug effectiveness was the most highly ranked and rated of eight osteoporosis medication attributes. Side effects and drug interactions were also highly ranked and rated. Healthcare providers should consider incorporating patient preferences for key medication attributes into their therapeutic decision-making processes.

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PubMed2006

Redefining osteoporosis treatment: Who to treat and how long to treat.

Osteoporosis is a common disease that is associated with increased risk of fractures and serious clinical consequences. Bone mineral density (BMD) testing is used to diagnose osteoporosis, estimate the risk of fracture, and monitor changes in BMD over time. Combining clinical risk factors for fracture with BMD is a better predictor of fracture risk than BMD or clinical risk factors alone. Methodologies are being developed to use BMD and validated risk factors to estimate the 10-year probability of fracture, and then combine fracture probability with country-specific economic assumptions to determine cost-effective intervention thresholds. The decision to treat is based on factors that also include availability of therapy, patient preferences, and co-morbidities. All patients benefit from nonpharmacological lifestyle treatments such a weight-bearing exercise, adequate intake of calcium and vitamin D, fall prevention, avoidance of cigarette smoking and bone-toxic drugs, and moderation of alcohol intake. Patients at high risk for fracture should be considered for pharmacological therapy, which can reduce fracture risk by about 50%.

Accidental Falls↗

PubMed2005

Rationale, objectives and design of the Direct Analysis of Nonvertebral Fracture in the Community Experience (DANCE) study.

The experience in randomized placebo-controlled clinical trials may differ from that in community practice. The pivotal teriparatide [rhPTH(1-34)] studies were initiated when few therapeutic options for osteoporosis were available. The Direct Analysis of Non-Vertebral Fractures in Community Experience (DANCE) study is a prospective observational trial designed to examine the occurrence of nonvertebral fragility fractures in a large, diverse patient population treated with teriparatide. The occurrence of clinical vertebral fractures and back pain will also be examined, as will bone mineral density, bone mineral content, bone area, safety and tolerability. Subjects will be followed through a course of teriparatide therapy for up to 24 months and for an additional 24 months after cessation of treatment. Therefore, subjects may participate in this study for up to 48 months. DANCE will provide data on the effectiveness and tolerability of teriparatide therapy in clinical practice that will complement the results of published controlled clinical trials.

Bone Density↗

PubMed2005

Quality-of-life issues in osteoporosis.

Osteoporosis is responsible for more than 1.5 million fractures per year in the United States including vertebral and nonvertebral fractures of the hip and wrist. Most of the impact of osteoporosis on quality of life relates to fracture. While the morbidity and mortality of hip fractures have long been recognized, only recently have we also recognized the significant burden of vertebral fractures. With the development of generic and disease targeted quality-of-life instruments we have now confirmed observational studies showing that clinical vertebral fractures have significant effects on quality of life. The economic burden of vertebral fractures, if we include direct and indirect costs, may be similar to hip fractures. The relative risk for mortality after clinical vertebral fracture is at least equivalent to that of hip fracture. The burden of vertebral fractures relates not only to pain but also to kyphosis. Because vertebral fractures are often under diagnosed and under treated, these findings are a call to action because the first vertebral fracture leads to significantly increased risk for subsequent vertebral and osteoporotic fracture with further loss of quality of life.

Cost of Illness↗

PubMed2005

Relationship of health related quality of life to prevalent and new or worsening back pain in postmenopausal women with osteoporosis.

OBJECTIVE: To examine the association between back pain and health related quality of life (HRQOL) in postmenopausal women with osteoporosis. METHODS: The Fracture Prevention Trial was a prospective double blinded, placebo controlled study designed to compare the proportion of women receiving teriparatide who experienced a new fracture to the proportion of women receiving placebo who experienced a new fracture. Subjects were ambulatory postmenopausal women with osteoporosis and prior vertebral fracture. As part of this trial, English-speaking women from Canada, New Zealand, Australia, and the United States participated in a HRQOL substudy using the Osteoporosis Assessment Questionnaire (OPAQ). OPAQ was administered at baseline, 12 months, and at study termination (median treatment duration 19 mo). Back pain data were collected as part of the adverse event monitoring during the trial. Subjects considered to have experienced back pain reported this event spontaneously and were not queried specifically. We examined the influence of prevalent back pain on HRQOL after controlling for spine deformity index score, and the influence of new or worsening back pain on HRQOL after controlling for incident vertebral fracture. RESULTS: Of 471 women who completed OPAQ at baseline, 172 reported back pain that was associated with a mean decrease in all OPAQ dimension scores (p < 0.05). Of 429 women who completed OPAQ at all timepoints, 88 experienced new or worsening back pain that was associated with a mean decrease in physical function, emotional status, and symptoms scores (p < 0.01 for each). In a subset of 65 women who experienced moderate to severe back pain, all OPAQ dimensions were significantly reduced (p < 0.05). CONCLUSION: Both prevalent back pain and new or worsening back pain affected HRQOL negatively. Osteoporosis therapies that prevent the development of back pain in postmenopausal women may also prevent decreases in HRQOL.

Affect↗

PubMed2004

Increasing hip fracture incidence in California Hispanics, 1983 to 2000.

BACKGROUND: Hip fracture incidence in non-Hispanic whites (NHW) has decreased nationwide for the past 20 years. Little is known regarding hip fracture incidence among Hispanics, the largest, fastest growing minority in the United States. OBJECTIVE: To assess the change in standardized hip fracture incidence from 1983 through 2000 in California Hispanics relative to other racial groups. DESIGN: Hospitalizations for individuals older than 55 years with hip fracture requiring repair in acute care hospitals. Annual population estimates based on US Census Bureau estimates. Incidence standardized to national gender-age strata. Change in annual incidence calculated by weighted linear regression with robust variance estimates. RESULTS: 372,078 hip fractures were identified. Age-adjusted annual incidence of hip fractures declined by 0.74% per year among women (655 to 568 per 100,000), but was unchanged among men (247 to 238 per 100,000). Among NHW women, the standardized annual incidence fell by 0.6% (4.0 fractures per 100,000) per year. Annual incidence among Hispanic women increased 4.9% (11.1 fractures per 100,000) per year. Annual incidence among Hispanic men increased by 4.2% (4.5 fractures per 100,000) per year and among NHW men by 0.5% (1.2 fractures per 100,000) per year. No significant change occurred among black or Asian women or men. CONCLUSIONS: Among California women, hip fracture incidence has doubled among Hispanics since 1983, while remaining unchanged or declining in other groups. Greater attention should be given to identification of individuals at risk for hip fracture and initiation of preventive measures in Hispanic populations.

Age Distribution↗

PubMed2004

Osteoporosis self-management: Choices For Better Bone Health.

Despite recent pharmacologic advances in the prevention and treatment of osteoporosis, the disease remains incurable. Effective disease management ultimately lies in the hands of the individual patient, who must take responsibility for key health behaviors related to bone health. One behavior modification strategy that has proven effective, but which has not previously been applied to osteoporosis, is "self-management." This article describes the principals, evolution, and initial outcomes of a new self-management program, Choices For Better Bone Health. Choices is a group education course directed to postmenopausal women who are at risk or already affected by osteoporosis, and has shown positive results in early evaluations.

Behavior Therapy↗

PubMed2004

Comparison of fracture, cardiovascular event, and breast cancer rates at 3 years in postmenopausal women with osteoporosis.

OBJECTIVES: To compare event rates for osteoporotic fractures, cardiovascular events, and breast cancer in postmenopausal women with osteoporosis. DESIGN: A prospective, observational study of the placebo group in the double-blind, randomized Multiple Outcomes of Raloxifene Evaluation trial. SETTING: One hundred eighty clinical research centers in 25 countries. PARTICIPANTS: Postmenopausal women (n=2,565, mean age=67) with osteoporosis were given calcium (500 mg/d) and vitamin D (400-600 IU/d) supplements. MEASUREMENTS: The occurrence of at least one new fracture, cardiovascular event, or breast cancer diagnosis at 3 years was identified and adjudicated. RESULTS: The occurrence of any fracture was the most common event in these women. In women without prevalent vertebral fractures (n=1,627), the event rates per 1,000 patient-years were 45.4 for any fracture, 15.2 for vertebral fracture, 4.7 for clinical vertebral fracture, 0.9 for hip fracture, 8.3 for any cardiovascular event, and 5.2 for all breast cancer. In women with prevalent vertebral fractures (n=938), the event rates per 1,000 patient-years were 117.4 for any new fracture, 77.1 for new vertebral fracture, 25.7 for clinical vertebral fracture, 5.8 for hip fracture, 15.1 for any cardiovascular event, and 2.6 for all breast cancer. The effect of prevalent fracture status on event rates was not dependent on whether women were older or younger than 65, but women aged 65 and older had a 3.6 times greater occurrence of cardiovascular events than younger women, irrespective of prevalent fracture status. CONCLUSION: These data on the relative incidence of clinically significant skeletal and extra-skeletal outcomes may be useful in choosing an agent for health maintenance for postmenopausal women with osteoporosis.

Age Distribution↗

PubMed2003

Calcitonin.

Calcitonin is FDA approved for the treatment of postmenopausal osteoporosis but not for prevention. The preferred delivery system is nasal. Nasal calcitonin is safe and well tolerated. The vertebral fracture efficacy of calcitonin is less robust than the two approved bisphosphonates (alendronate and risedronate) but is similar to raloxifene in the treatment of established osteoporosis. Calcitonin has not been demonstrated to reduce hip fracture risk, although a post-hoc pooled analysis suggests potential effectiveness of nasal calcitonin. Calcitonin produces small increments in bone mass of the spine and modestly reduces bone turnover in women with osteoporosis. Calcitonin may have analgesic benefit in patients with acute painful vertebral fractures. Treatment with calcitonin should be considered for older women with osteoporosis with painful vertebral fractures and for women who fail to respond to or cannot tolerate bisphosphonates. Calcitonin may also be indicated for women who are unable to take bisphosphonates because of impaired renal function.

Administration, Intranasal↗

PubMed2003

The impact of incident vertebral and non-vertebral fragility fractures on health-related quality of life in established postmenopausal osteoporosis: results from the teriparatide randomized, placebo-controlled trial in postmenopausal women.

OBJECTIVE: To report the combined impact of both vertebral and non-vertebral fractures on decreased health-related quality of life (HRQOL) in postmenopausal women (mean age 70.7) with osteoporosis who participated in a clinical trial to examine the anti-fracture efficacy of teriparatide [rhPTH(1-34)] injection. METHODS: Patients were randomly assigned to 1 of 3 study arms: placebo, 20 micro g or 40 micro g of teriparatide by daily self-injection. All patients received daily calcium (1000 mg) and vitamin D (400-1200 U) supplements. Patients were followed for a median of 21 months. Incident vertebral fractures were assessed by lateral spinal radiograph. Incident non-vertebral fractures were ascertained by patient self-report and verified by a review of radiological reports. HRQOL was assessed at baseline and annually until study termination using the Osteoporosis Assessment Questionnaire (OPAQ), a validated disease-targeted instrument. RESULTS: Of the 365 women in the HRQOL sub-study, 53 had an incident vertebral or non-vertebral fracture during the study period. Compared to women without incident fractures, women who fractured reported significant declines in physical functioning, emotional status, and symptoms (all p < 0.05). Similarly, when analysis was limited to patients with significant loss in HRQOL, patients with incident fracture accounted for a greater proportion of those patients with decreased physical function, emotional status, and increased symptoms (all p < 0.05). CONCLUSION: Our results confirm and extend previous findings to show that a composite endpoint of incident vertebral and non-vertebral fractures in women with postmenopausal osteoporosis was associated with significant decreases in HRQOL.

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