Recommendations for the conduct of economic evaluations in osteoporosis: outcomes of an experts' consensus meeting organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the US branch of the International Osteoporosis Foundation.

Economic evaluations are increasingly used to assess the value of health interventions, but variable quality and heterogeneity limit the use of these evaluations by decision-makers. These recommendations provide guidance for the design, conduct, and reporting of economic evaluations in osteoporosis to improve their transparency, comparability, and methodologic standards. INTRODUCTION: This paper aims to provide recommendations for the conduct of economic evaluations in osteoporosis in order to improve their transparency, comparability, and methodologic standards. METHODS: A working group was convened by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis to make recommendations for the design, conduct, and reporting of economic evaluations in osteoporosis, to define an osteoporosis-specific reference case to serve a minimum standard for all economic analyses in osteoporosis, to discuss methodologic challenges and initiate a call for research. A literature review, a face-to-face meeting in New York City (including 11 experts), and a review/approval by a larger group of experts worldwide (including 23 experts in total) were conducted. RESULTS: Recommendations on the type of economic evaluation, methods for economic evaluation, modeling aspects, base-case analysis and population, excess mortality, fracture costs and disutility, treatment characteristics, and model validation were provided. Recommendations for reporting economic evaluations in osteoporosis were also made and an osteoporosis-specific checklist was designed that includes items to report when performing an economic evaluation in osteoporosis. Further, 12 minimum criteria for economic evaluations in osteoporosis were identified and 12 methodologic challenges and need for further research were discussed. CONCLUSION: While the working group acknowledges challenges and the need for further research, these recommendations are intended to supplement general and national guidelines for economic evaluations, improve transparency, quality, and comparability of economic evaluations in osteoporosis, and maintain methodologic standards to increase their use by decision-makers.

Persistence at 24 months with denosumab among postmenopausal women with osteoporosis: results of a prospective cohort study.

Persistence with prescribed medications for chronic diseases is important; however, persistence with osteoporosis treatments is historically poor. In this prospective cohort study of postmenopausal women treated for osteoporosis in real-world clinical practice settings in the USA and Canada, 24-month persistence with denosumab was 58%. PURPOSE: Patients who persist with their prescribed osteoporosis treatment have increased bone mineral density (BMD) and reduced risk of fracture. Twelve-month persistence with denosumab in routine clinical practice is as high as 95%, but there are limited data on longer-term persistence with denosumab in this setting. METHODS: This single-arm, prospective, cohort study evaluated 24-month persistence with denosumab administered every 6 months in postmenopausal women receiving treatment for osteoporosis in real-world clinical practice in the USA and Canada. Endpoints and analyses included the percentage of patients who persist with denosumab at 24 months (greater than or equal to four injections with a gap between injections of no more than 6 months plus 8 weeks), the total number of injections received by each patient, changes in BMD in persistent patients, and the incidence of serious adverse events (SAEs) and fractures. RESULTS: Among 935 enrolled patients, 24-month persistence was 58% (50% in US patients and 75% in Canadian patients). A majority of patients received at least four injections over the observation period (62% of US patients and 81% of Canadian patients). Among patients who were persistent at 24 months and who had a baseline, 12-month, and 24-month DXA scan, mean BMD increased from baseline to 24 months by 7.8% at the lumbar spine and 2.1% at the femoral neck. SAEs and fractures were reported for 122 (13.0%) patients and 54 (5.8%) patients, respectively. CONCLUSIONS: Persistence with denosumab for 24 months yields improvement in BMD among postmenopausal women with osteoporosis treated in routine clinical practice in the USA and Canada.

The importance of physical function to people with osteoporosis.

There is increasing need to understand patient outcomes in osteoporosis. This article discusses that fracture in osteoporosis can lead to a cycle of impairment, driven by complex psychosocial factors, having a profound impact on physical function/activity which accumulates over time. More information is required on how treatments impact physical function. INTRODUCTION: There is increasing need to understand patient-centred outcomes in osteoporosis (OP) clinical research and management. This multi-method paper provides insight on the effect of OP on patients' physical function and everyday activity. METHODS: Data were collected from three sources: (1) targeted literature review on OP and physical function, conducted in MEDLINE, Embase and PsycINFO; (2) secondary thematic analysis of transcripts from patient interviews, conducted to develop a patient-reported outcome instrument. Transcripts were re-coded to focus on OP impact on daily activities and physical function for those with and without fracture history; and (3) discussions of the literature review and secondary qualitative analysis results with three clinical experts to review and interpret the importance and implications of the findings. RESULTS: Results suggest that OP, particularly with fracture, can have profound impacts on physical function/activity. These impacts accumulate over time through a cycle of impairment, as fracture leads to longer term detriments in physical function, including loss of muscle, activity avoidance and reduced physical capacity, which in turn leads to greater risk of fracture and potential for further physical restrictions. The cycle of impairment is complex, as other physical, psychosocial and treatment-related factors, such as comorbidities, fears and beliefs about physical activity and fracture risk influence physical function and everyday activity. CONCLUSION: More information on how treatments impact physical function would benefit healthcare professionals and persons with OP in making treatment decisions and improving treatment compliance/persistence, as these impacts may be more salient to patients than fracture incidence.

International Osteoporosis Foundation and European Calcified Tissue Society Working Group. Recommendations for the screening of adherence to oral bisphosphonates.

Adherence to oral bisphosphonates is low. A screening strategy is proposed based on the response of biochemical markers of bone turnover after 3 months of therapy. If no change is observed, the clinician should reassess the adherence to the treatment and also other potential issues with the drug. INTRODUCTION: Low adherence to oral bisphosphonates is a common problem that jeopardizes the efficacy of treatment of osteoporosis. No clear screening strategy for the assessment of compliance is widely accepted in these patients. METHODS: The International Osteoporosis Foundation and the European Calcified Tissue Society have convened a working group to propose a screening strategy to detect a lack of adherence to these drugs. The question to answer was whether the bone turnover markers (BTMs) PINP and CTX can be used to identify low adherence in patients with postmenopausal osteoporosis initiating oral bisphosphonates for osteoporosis. The findings of the TRIO study specifically address this question and were used as the basis for testing the hypothesis. RESULTS: Based on the findings of the TRIO study, specifically addressing this question, the working group recommends measuring PINP and CTX at baseline and 3 months after starting therapy to check for a decrease above the least significant change (decrease of more than 38% for PINP and 56% for CTX). Detection rate for the measurement of PINP is 84%, for CTX 87% and, if variation in at least one is considered when measuring both, the level of detection is 94.5%. CONCLUSIONS: If a significant decrease is observed, the treatment can continue, but if no decrease occurs, the clinician should reassess to identify problems with the treatment, mainly low adherence.

Persistence at 12 months with denosumab in postmenopausal women with osteoporosis: interim results from a prospective observational study.

UNLABELLED: To determine persistence with subcutaneous denosumab every 6 months in women being treated for osteoporosis, we conducted a single-arm prospective, observational study in the United States and Canada. Among 935 patients enrolled, 12-month persistence was 82%, with 66 patients (7%) reporting serious adverse events and 19 patients (2%) reporting fractures. INTRODUCTION: Increased persistence with osteoporosis therapy is associated with reduced fracture risk. Denosumab reduced fracture risk in clinical trials; persistence in community settings is undetermined. This study evaluates persistence with denosumab in community practice in the United States (US) and Canada. METHODS: In a 24-month multicenter, prospective, single-arm, observational study, women being treated for osteoporosis were enrolled ≤4 weeks after the first subcutaneous injection of denosumab. For this 12-month prespecified interim analysis, endpoints include persistence (one injection at study entry and another within 6 months + 8 weeks), attributes associated with persistence (univariate analysis), and serious adverse events (SAEs). RESULTS: Among 935 patients (mean age 71 years), mean baseline T-scores were -2.18 (femoral neck) and -2.00 (lumbar spine); 50% of patients had experienced osteoporotic fracture(s). At 12 months, 82 % of patients were persistent with denosumab. Baseline factors significantly (p < 0.05) associated with higher persistence included use of osteoporosis medications >5 years previously, lumbar spine T-score > -2.5, and treatment by female physicians (US). Lower persistence was associated (p < 0.05) with psychiatric diagnoses including depression, southern US residence, being divorced, separated, or widowed (US), and prior hip fracture (Canada). SAEs were reported in 66 patients (7%); no SAEs of osteonecrosis of the jaw, atypical femoral fracture, fracture healing complications, hypocalcemia, eczema, or hypersensitivity were reported. Nineteen patients (2%) reported osteoporotic fractures. CONCLUSIONS: The 12-month persistence observed in this single-arm open-label study of US and Canadian community practice extends the evidence regarding denosumab's potential role in reducing fracture risk in postmenopausal women with osteoporosis.

Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF): a psychometrically validated osteoporosis-targeted patient reported outcome measure of daily activities of physical function.

UNLABELLED: The purpose of this study was to evaluate the measurement properties of the Osteoporosis Assessment Questionnaire-Physical Functioning (OPAQ-PF). Based on this study, the OPAQ-PF has confirmed unidimensionality and acceptable reliability, construct validity, and sensitivity to change in a recent fracture/no recent fracture osteoporosis sample. METHODS: Dimensionality was established through exploratory and confirmatory factor analysis. Patients completed three patient reported outcome (PRO) measures and four performance-based measures (PBMs) at baseline to enable an evaluation of construct validity. Patients without a recent fracture completed the OPAQ-PF 2 weeks after baseline to enable an evaluation of test-retest reliability. Ability to detect change and interpretation of change were investigated following completion of the OPAQ-PF 12 and 24 weeks postbaseline by patients with a recent fracture. RESULTS: A prospective psychometric validation study in 144 postmenopausal women, with moderate to severe osteoporosis, 37 of whom had experienced a recent fragility fracture (<6 weeks). Unidimensionality was established for the OPAQ-PF by factor analysis. The OPAQ-PF had good internal consistency (α = 0.974) and test-retest reliability (mean intraclass correlation coefficient (ICC) 0.993. The OPAQ-PF differentiated between patients with/without recent fracture, and by severity of osteoarthritis; it correlated strongly with hypothesized-related scales and PBMs (r > 0.3, p < 0.001). Ability to detect change was established with high correlations between changes in OPAQ-PF score and changes in global concept scores in recent fracture patients (r ≥ 0.6, 24-week change). Effect size of change on OPAQ-PF score increased by level of global change (p < 0.001). Anchor-based methods identified an OPAQ-PF change of 10 at an individual patient level and 20 at a group level as meaningful to patients. CONCLUSIONS: The OPAQ-PF has confirmed unidimensionality and acceptable reliability, construct validity, and sensitivity to change in a recent fracture/no recent fracture osteoporosis sample.

Development of the Osteoporosis Assessment Questionnaire--physical Function (OPAQ-PF): an osteoporosis-targeted, patient-reported outcomes (PRO) measure of physical function.

UNLABELLED: We have developed a short, patient-reported outcome questionnaire--the Osteoporosis Assessment Questionnaire--Physical Function (OPAQ-PF)--that assesses the impact of osteoporosis on physical function. OPAQ-PF contains 15 items in three domains (mobility, physical positions, and transfers) and has content validity in osteoporosis patients with and without a history of fracture. INTRODUCTION: This paper describes the development of the Osteoporosis Assessment Questionnaire--Physical Function (OPAQ-PF), a patient-reported outcome (PRO) questionnaire based on OPAQ v.2.0 (60 items, 14 domains) that assesses the impact of osteoporosis on physical function. METHODS: OPAQ v.2.0 was administered to patients with osteoporosis. Item response theory methodology and clinical judgment were used to retain/eliminate items. The resulting instrument was modified during two sets of concept elicitation and cognitive debriefing interviews with osteoporosis patients. RESULTS: Item response theory-based analysis of OPAQ v.2.0 (n = 1,478) coupled with clinician input resulted in the generation of a 21-item, six-domain instrument with a frequency response format. Interview data from 32 participants were used to modify this version and led to generation of the final instrument, OPAQ-PF. This final version has a severity response format and contains 15 items in three domains (mobility, physical positions, and transfers) that group together to provide an overall assessment of physical function in patients with osteoporosis. Twenty-two of the 32 interview participants (69 %) had previously sustained a fracture. Symptoms occurred primarily in these patients. CONCLUSIONS: OPAQ-PF represents a brief, focused, PRO instrument that assesses physical function in patients with osteoporosis, specifically related to mobility, physical positions, and transfers. This questionnaire has content validity in osteoporosis patients who have, and have not, sustained a prior fracture.

Primary non-adherence to bisphosphonates in an integrated healthcare setting.

UNLABELLED: We estimated primary non-adherence to oral bisphosphonate medication and examined the factors associated with primary non-adherence. Nearly 30% of women did not pick up their new bisphosphonate within 60 days. Identifying barriers and developing interventions that address patients' needs and concerns at the time a new medication is prescribed are warranted. INTRODUCTION: To estimate primary non-adherence to oral bisphosphonate medications using electronic medical record data in a large, integrated healthcare delivery system and to describe patient and prescribing provider factors associated with primary non-adherence. METHODS: Women aged 55 years and older enrolled in Kaiser Permanente Southern California (KPSC) with a new prescription for oral bisphosphonates between December 1, 2009 and March 31, 2011 were identified. Primary non-adherence was defined as failure to pick up the new prescription within 60 days of the order date. Multivariable logistic regression models were used to investigate patient factors (demographics, healthcare utilization, and health conditions) and prescribing provider characteristics (demographics, years in practice, and specialty) associated with primary non-adherence. RESULTS: We identified 8,454 eligible women with a new bisphosphonate order. Among these women, 2,497 (29.5%) did not pick up their bisphosphonate prescription within 60 days of the order date. In multivariable analyses, older age and emergency department utilization were associated with increased odds of primary non-adherence while prescription medication use and hospitalizations were associated with lower odds of primary non-adherence. Prescribing providers practicing 10 or more years had lower odds of primary non-adherent patients compared with providers practicing less than 10 years. Internal medicine and rheumatology providers had lower odds of primary non-adherent patients than primary care providers. CONCLUSION: This study found that nearly one in three women failed to pick up their new bisphosphonate prescription within 60 days. Identifying barriers and developing interventions aimed at reducing the number of primary non-adherent patients to bisphosphonate prescriptions are warranted.

Oral bisphosphonates reduce the risk of clinical fractures in glucocorticoid-induced osteoporosis in clinical practice.

UNLABELLED: This study aims to estimate bisphosphonate effectiveness by comparing fracture incidence over time on therapy in glucocorticoid-induced osteoporosis (GIO). From this observational study, alendronate and risedronate decreased clinical vertebral and nonvertebral fractures over time. The effectiveness of each bisphosphonate is consistent with their efficacies demonstrated on surrogate markers in randomized controlled trials (RCTs). INTRODUCTION: This study aims to estimate bisphosphonate effectiveness by comparing fracture incidence over time on therapy with fracture incidence during a short period after starting a therapy. METHODS: The study population was a subgroup of a larger cohort study comprising two cohorts of women aged ≥65 years, prescribed with alendronate or risedronate. Within the two study cohorts, 11,007 women were identified as having received glucocorticoids. Within each cohort, the baseline incidence of clinical fractures at nonvertebral and vertebral sites was defined by the initial 3-month period after starting therapy. Relative to these baseline data, we then compared the fracture incidence during the subsequent 12 months on therapy. RESULTS: The baseline incidence of clinical nonvertebral and vertebral fractures was similar in the alendronate cohort (5.22 and 5.79/100 person-years, respectively) and in the risedronate cohort (5.51 and 5.68/100 person-years, respectively). Relative to the baseline incidence, fracture incidence was significantly lower in the subsequent 12 months in both cohorts of alendronate (33 % lower at nonvertebral sites and 59 % at vertebral sites) and risedronate (28 % lower at nonvertebral sites and 54 % at vertebral sites). CONCLUSION: From this observational study not designed to compare drugs, both alendronate and risedronate decreased clinical vertebral and nonvertebral fractures over time. The reductions observed in fracture incidence, within each cohort, suggest that the effectiveness of each bisphosphonate in clinical practice is consistent with their efficacies demonstrated on surrogate markers in randomized controlled trials.

Patient weighting of osteoporosis medication attributes across racial and ethnic groups: a study of osteoporosis medication preferences using conjoint analysis.

UNLABELLED: We studied the ranking of osteoporosis (OP) medication attributes in a convenience sample of four different racial/ethnic groups in the United States. Our study showed that postmenopausal women differ in the ranking of OP medication attributes based on age, educational level, income, and prior fracture history. INTRODUCTION: Decision making about OP medication-related behavior relies heavily on patient preferences about specific medication attributes. Patients may decide to initiate, change, or stop therapies based on ranking of perceived attributes of the therapy and their personal attitudes toward those attributes. We used MaxDiff, a form of conjoint analysis (Ryan and Farrar 2000), to explore patient weighting of attributes across four racial/ethnic groups at two sites in the United States and defined four critical attributes that influence such decisions (safety, efficacy, cost, and convenience) from qualitative interviews. METHODS: We recruited a sample of 367 Postmenopausal (PM) women at risk of OP fractures from four racial/ethnic groups: Caucasian (n = 100), African American (n = 100), Asian American (n = 82), and Hispanic American (n = 85). Respondents completed a laptop-based questionnaire that included demographic items, several short scales on medical care preference and OP patient perceptions, and a MaxDiff procedure that determines comparative ranking of attributes either as least important or most important to their decisions. RESULTS: MaxDiff analyses were done to evaluate the relative weight of specific statements for each participant and to determine whether racial/ethnic groups differed across dimensions. Overall, participants in all four groups rated efficacy > safety > cost > convenience. CONCLUSIONS: Although there were no significant differences among the racial/ethnic groups on overall ranking of attributes, subgroup analyses revealed significant impact of age, education, income, and prior fracture on these decisions. The findings from this study suggest that postmenopausal women differ in their ranking of OP medication attributes, and healthcare providers must account for personal preferences in their communication about and selection of OP medications.

Measuring health-related quality of life (HRQOL) in osteoporotic males using the Male OPAQ.

UNLABELLED: The Male Osteoporosis Assessment Questionnaire (OPAQ™) is a health-related quality of life (HRQOL) instrument that can differentiate between men with and without fracture. The Male OPAQ™ is a reliable and validated instrument that may be utilized in clinical trials seeking to include male populations. INTRODUCTION: Men with osteoporosis (OP) experience poorer clinical outcomes than do women with the disorder, but little is known about the impact of OP on men's HRQOL. This study aimed to test the validity, reliability, and ability to differentiate between men with and without fracture of an HRQOL for men with osteoporosis, the Male OPAQ™. METHODS: The OPAQ and OPAQ-SV were tested for face validity in interviews with male OP patients, and a revised, male-specific instrument was developed. Thirty-seven men ages 50+ completed the Male OPAQ™ and SF-12 at baseline and a two-week retest of the Male OPAQ™. To analyze both the domain and dimension scores, a normalization procedure was performed on the data to determine health status scores from 0 to 100. Descriptive statistics were calculated for each item and site. Reliability and validity of the Male OPAQ™ were assessed using Pearson's r. RESULTS: The Male OPAQ™ can discriminate between men with and without fracture, and men who have more fractures have poorer scores. Instrument domains correspond to those of the SF-12. CONCLUSIONS: The Male OPAQ(TM) is a brief and sensitive tool for measuring HRQOL in men with OP. Further testing in a more diverse and large sample is warranted.

Oral bisphosphonate compliance and persistence: a matter of choice?

Compliance to oral bisphosphonates is suboptimal, with negative consequences of increased healthcare utilization and less effective fracture risk reduction. Extending dose interval increased adherence only moderately. We used literature derived from multiple chronic conditions to examine the problem of noncompliance with osteoporosis medication. We reviewed the literature on adherence to osteoporosis medication as well as that across multiple chronic conditions to understand what is known about the cause of the poor adherence. Poor compliance to oral medications is due mostly, not to forgetfulness, but to deliberate choice. Gender differences and style of healthcare management also play a role. Preliminary data suggest psychobehavioral interventions may help to improve motivation. We need to understand better reasons for poor compliance before effective interventions can be developed. Forgetfulness is only a small part of poor compliance. Patient preferences must be considered in medication decision making.

Longitudinal change in clinical fracture incidence after initiation of bisphosphonates.

SUMMARY: There are differences in the risk profile of patients prescribed alendronate, risedronate, or ibandronate. Observed reductions in fracture incidence over time suggest that the effectiveness of each bisphosphonate in clinical practice has been consistent with their efficacies demonstrated in randomized controlled trials. INTRODUCTION: Observational studies of bisphosphonate effectiveness for fracture prevention are subject to bias from unknown characteristics of baseline fracture risk at the start of therapy. The fracture incidence during the short period after starting a bisphosphonate and before any expected clinical benefit likely reflects baseline fracture risk. Bisphosphonate effectiveness may then be estimated by measuring the change in fracture incidence over time on therapy. METHODS: Administrative billing data were used to follow three cohorts of women aged 65 and older (total n = 210,144) after starting therapy either on alendronate, risedronate, or ibandronate in the USA between market introduction and 2006. Within each cohort, the baseline incidence of clinical fractures at the hip, vertebral, and nonvertebral sites was defined by the initial 3-month period after starting therapy. Relative to these baselines, we then compared the fracture incidence during the subsequent 12 months on therapy. RESULTS: At the start of therapy, the ibandronate cohort was younger and had fewer prior fractures than either the risedronate or alendronate cohorts. Accordingly, the baseline incidence of hip fractures was higher in the risedronate cohort (0.90 per 100 person-years) and in the alendronate cohort (0.77) than in the ibandronate cohort (0.64). Relative to the baseline incidence, fracture incidence was significantly lower in the subsequent 12 months in both cohorts of alendronate (18% lower at hip, 28% at nonvertebral sites, and 57% at vertebral sites) and risedronate (27% lower at hip, 21% at nonvertebral sites, and 54% at vertebral sites). In the ibandronate cohort, the fracture incidence was lower (31%) only at vertebral sites. CONCLUSIONS: Differences in the baseline fracture incidence among the cohorts may reflect differences in the risk profile of patients prescribed each bisphosphonate. The reductions observed in fracture incidence over time within each cohort suggest that the effectiveness of each bisphosphonate in clinical practice has been consistent with their efficacies demonstrated in randomized controlled trials.

Preference and satisfaction with a 6-month subcutaneous injection versus a weekly tablet for treatment of low bone mass.

UNLABELLED: The Preference and Satisfaction Questionnaire (PSQ) compares patient preference and satisfaction between a 6-month subcutaneous injection and weekly oral tablet for treatment of bone loss. Patients preferred and were more satisfied with a treatment that was administered less frequently, suggesting the acceptability of the 6-month injection for treatment of bone loss. INTRODUCTION: The PSQ compares patient preference and satisfaction between a 6-month subcutaneous injection and a weekly oral tablet for treatment of bone loss. METHODS: Postmenopausal women with low bone mass who enrolled in two separate randomized phase 3 double-blind, double-dummy studies received a 6-month subcutaneous denosumab injection (60 mg) plus a weekly oral placebo or a weekly alendronate tablet (70 mg) plus a 6-month subcutaneous placebo injection. After 12 months, patients completed the PSQ to rate their preference, satisfaction, and degree of bother with each regimen. RESULTS: Most enrolled patients (1,583 out of 1,693; 93.5%) answered >or=1 item of the PSQ. Significantly more patients preferred and were more satisfied with the 6-month injection versus the weekly tablet (P < 0.001). More patients reported no bother with the 6-month injection (90%) than the weekly tablet (62%). CONCLUSION: Patients preferred, were more satisfied, and less bothered with a 6-month injection regimen for osteoporosis.

A systematic review of persistence and compliance with bisphosphonates for osteoporosis.

UNLABELLED: Fourteen reports utilizing data from de-identified administrative databases were reviewed. Studies contained at least one measure of patient persistence or compliance with bisphosphonates or bisphosphonates and other anti-osteoporosis medications. These studies confirm that women with osteoporosis have suboptimal persistence and compliance rates with bisphosphonate therapy. INTRODUCTION: This review summarizes patient persistence and compliance with bisphosphonates for the treatment of osteoporosis. METHODS: We conducted a MEDLINE search for the period from January 1998 to May 2006, using a detailed list of terms related to persistence and compliance with anti-osteoporosis medications. Studies were included if they contained at least one measure of persistence or compliance derived from de-identified administrative databases containing patient demographics and prescription information. RESULTS: We reviewed 14 reports, which described 14 databases. The percentage of patients persisting with therapy for 1 year ranged from 17.9% to 78.0%. Compliance, assessed as mean medication possession ratio (MPR), ranged from 0.59 to 0.81. When comparing compliance with weekly and daily bisphosphonates, the mean MPR was consistently higher for weekly versus daily therapy (0.58 to 0.76 versus 0.46 to 0.64 for patients receiving weekly and daily bisphosphonate therapy respectively). Persistence was also improved in patients receiving weekly bisphosphonates, assessed by both length of persistence (194 to 269 days [weekly] and 134 to 208 days [daily]) and percentage of persistent patients at the end of the follow-up period (35.7% to 69.7% [weekly] and 26.1% to 55.7% [daily]). CONCLUSION: Although patients using weekly bisphosphonate medication follow their prescribed dosing regimens better than those using daily therapy, overall compliance and persistence rates were suboptimal.

Disability as a function of social networks and support in elderly African Americans and Whites: the Duke EPESE 1986--1992.

OBJECTIVES: We examined the association of structural and functional aspects of social relationships with change in disability, and the degree to which race modifies these associations. METHODS: Data are from a population-based sample of 4,136 African Americans and Whites aged > or = 65 living in North CAROLINA: Disability data were collected during seven consecutive yearly interviews and summarized in two outcome measures. Measures of social relationships included five measures representing network size, extent of social interaction, and specific type of relationships, as well as instrumental and emotional support. Weighted proportional odds models were fitted to model disability as a function of baseline social network and support variables, and the interaction of each variable with follow-up time. RESULTS: Network size and social interaction showed significant negative associations with disability risks, which did not vary by race, or as a function of time. Social interaction with friends was associated with a reduced risk for disability, but social interaction with children or relatives was not related to disability. Instrumental support was associated with a significantly increased disability risk, with a greater adverse effect among Whites than African AMERICANS: Emotional support was not associated with disability, but a protective effect for ADL disability was found after controlling for its intercorrelation with instrumental support. DISCUSSION: The findings provide further evidence for the role of social relationships in the disablement process, although not all types of social relationships may be equally beneficial. Furthermore, these associations may be more complex than simple causal effects. There were few racial differences in the association of social relationships with disability, with the possible exception of instrumental support, which may allude to possible sociocultural differences in the experience of instrumental support exchanges.

The nonskeletal consequences of osteoporotic fractures. Psychologic and social outcomes.

The prevalence of osteoporosis is rising as the population of the United States and other developed countries ages. These increasing numbers of people have motivated pharmaceutical companies to develop and market several antiresorptive medications that can slow down the bone loss associated with osteoporosis. Although these are not cures for this disease, they are an important first step in a vital ongoing public health effort to prevent osteoporosis in the future and to manage osteoporosis now. We cannot expect to remediate the problems caused by this disease if we attend only to its skeletal implications. Like any other chronic disease, osteoporosis has significant psychologic and social consequences. From anxiety and depression to social withdrawal and isolation, if these problems are left unresolved, they can have a significant negative impact not only on health issues but also on overall quality of life. No quick fixes exist for the numerous ways in which osteoporosis can transform an autonomous person into a dependent and hopeless patient. In part, responsibility for helping this patient rests with the medical community. Referrals to appropriate providers can improve a patient's physical and emotional well-being. Physician specialists can help the patient manage comorbid conditions. Physical and occupational therapists can teach exercises, home safety, and safe movement. Social workers can provide a framework for coping that enables individuals to improve their interpersonal interactions and minimize stress in their lives. Nutritionists, pharmacists, nurses, and other health care professionals can make major contributions to the quality of life of people with osteoporosis and should be encouraged to do so. Unfortunately, managed care has set policies that deprive patients with osteoporosis of the kinds of care that would be most useful to them. As we have advocated for the last 15 years, a multidisciplinary approach offers patients the most positive overall way to manage osteoporosis. Therefore, new alternatives need to be examined, alternatives that provide both low-cost and high-quality care. In the long run, patients who practice self-management, that is, those who take responsibility for their own calcium and vitamin D intake, are compliant with medications, exercise, and practice home safety, and who have a healthy outlook, can control their osteoporosis. The most effective intervention for the future may be to teach individuals how to use self-management strategies so that they can take charge of their osteoporosis and positively influence their quality of life.

Correlates and consequences of chronic pain in older adults.

Chronic pain is a frequent challenge to older adults' coping skills. Despite the widespread occurrence of chronic geriatric pain, no comprehensive body of literature on this topic exists. Instead, research on chronic pain is scattered across disciplines and is perceived as inaccessible by scientists. We completed a comprehensive review and qualitative analysis of the geriatric chronic pain literature since 1990 and found 314 articles on this topic that reported. North American research. Physical, social, and psychologic variables associated with chronic pain and the elderly were mentioned in just over half (53%) of the articles. However, both psychosocial causes and consequences of chronic pain were understudied. Only 16% of the articles had social variables (gender, race, and age) as their primary interest; 27% focused on psychologic or psychiatric issues, with half including depression as the variable of interest. An analysis of the articles' content suggests that research on chronic pain in later life would be substantially improved if a more structured and comprehensive approach were used that combined the study of psychosocial issues with that of physical pain. Researchers and clinicians with a global understanding of chronic pain might help improve quality of life for older adults.

Racial differences in use of cancer prevention services among older Americans.

CONTEXT: Racial differences in receipt of cancer prevention services may be related to poorer outcomes for minorities. Understanding reasons for such differences could help target appropriate interventions. OBJECTIVES: To determine if racial differences exist in the use of cancer prevention services among older blacks and whites and to explore explanatory factors. DESIGN: Sixth follow-up survey of probability sample, four-stage stratified household design with 4,162 at baseline in 1986-1987 and 2,846 surveyed in 1992-1993. SETTING: The Piedmont area of North Carolina. PARTICIPANTS: At time of follow-up survey in 1992-1993 there were 1,486 women and 726 men age >70 years, of whom 1,246 were black and 966 were white. MEASUREMENTS: Self-reported use of Papanicolou (pap) testing, clinical breast examination, mammography, rectal examination, and fecal occult blood testing on a regular basis within the last two years. RESULTS: Compared with older whites, older black persons are less likely to receive pap test (48.1% black vs 56.6% white, P < .001), clinical breast examination (64.6% black vs 69.2% white, P < .007), mammography (30.2% black vs 40.5% white, P < .001), rectal examination (50.2% black vs 62.4% white, P < .001), and fecal occult blood testing (37.5% black vs 46.2% white, P < .001). Effect of race on receipt of cancer prevention services was not significant when levels of education, income, and insurance coverage were considered. CONCLUSION: Racial differences exist in the use of cancer prevention services among older Americans. However, these differences are related to educational, income, and insurance differences between blacks and whites.

Effects of educational materials concerning osteoporosis on women's knowledge, beliefs, and behavior.

PURPOSE: This study examined the effects of brief written educational materials on osteoporosis-related knowledge, beliefs, and behaviors. The study also examined whether observed effects varied as a function of one's stage in the precaution adoption process. DESIGN: The study used an experimental research design. SETTING: Participants were identified from North Carolina driver's license records. SUBJECTS: Of the 1476 women in the initial sample, 536 (36.3%) enrolled in the study and 307 completed all follow-up assessments. INTERVENTION: Participants were randomly assigned to one of four groups. One group received an information packet containing general information about osteoporosis. One group received an action plan packet containing instructions on how to increase one's level of exercise and calcium intake. One group received both packets. The final group received neither packet. MEASURES: Primary study variables were beliefs related to osteoporosis, calcium, and exercise; osteoporosis knowledge; calcium and exercise stage; calcium intake; and exercise level. RESULTS: Overall, receipt of the information packet was associated with changes in knowledge and beliefs (F[18,283] = 2.11, p < .01) irrespective of participants' stage of change. No effects on behavior were observed. CONCLUSIONS: These findings suggest that brief written educational materials can facilitate knowledge and belief change but that they do not promote behavior change. The generalizability of these findings is limited by the low study response rate.