Treatment patterns in women with postmenopausal osteoporosis using abaloparatide: a real-world observational study.

Review of medical records from 173 women with osteoporosis who received abaloparatide treatment revealed that 96.0% had at least one visit for osteoporosis management and 55.5% had medication support group access. The most common reasons for discontinuing treatment were financial (31.2%) and tolerability (22.8%). Most patients (64.8%) completed treatment as prescribed. PURPOSE: Abaloparatide is approved for the treatment of women with postmenopausal osteoporosis at high risk for fracture. This study evaluated real-world treatment patterns for patients new to abaloparatide, regardless of osteoporosis treatment history. METHODS: Data for patients with ≥ 1 prescription for abaloparatide were collected retrospectively from six academic and clinical practice settings across the US. RESULTS: A total of 173 patients were enrolled (mean [SD] age, 69.8 [7.4] years). At the time of abaloparatide treatment initiation, 78.6% had received other osteoporosis medications. Mean (SD) time from discontinuation of osteoporosis medications prior to initiation of abaloparatide was 1.7 (3.2) years. Twenty-four months of follow-up data from the initiation date of abaloparatide was collected from 94.0% of patients and 6.0% of patients had 12-24 months of follow-up. During the follow-up period, 96.0% of patients had at least one visit for osteoporosis management and 55.5% had access to a medication support program. The median duration of therapy was 18.6 months and 105/162 (64.8%) completed abaloparatide treatment as prescribed. The most common reasons for treatment discontinuation were financial (31.2%) and tolerability (22.8%). Following completion of a course of treatment with abaloparatide, 82/162 (50.6%) patients transitioned to another osteoporosis medication. The median time between abaloparatide treatment course completion and the initiation of follow-on medication was 21 days. CONCLUSION: Most patients completed treatment with abaloparatide as prescribed, and over half continued with an antiresorptive agent. This favorable conduct may be the result of regular follow-up visits and accessibility to both medication and patient support services.

A Qualitative Study to Assess US Patient Preferences between new Transdermal System and Injectable Anabolic Therapies for Osteoporosis Treatment.

US patients with osteoporosis included in three focus groups identified efficacy, safety, cost, and convenience as important attributes of treatment when choosing between anabolic therapies with high stated preference for the solid Microstructured Transdermal System. OBJECTIVE: The current study evaluated patient perspective and relative importance of treatment attributes of in-home daily self-administration of abaloparatide-solid Microstructured Transdermal System (sMTS) compared with other anabolic agents (i.e. in-home daily subcutaneous self-injections, and monthly subcutaneous injections at doctor office) among a group of US patients with osteoporosis. METHODS: The current study included systematic literature reviews, experts' consultation and three online patients focus groups (n=27), including patients ≥50 years of age at high risk for fracture. Nominal Group Technique was used by asking patients to (1) Individually identify characteristics that would be important for them when choosing between anabolic treatments, (2) Share ideas and discuss perspectives with other patients, (3) Review additional attributes generated from a systematic literature review, (4) Select and rank individually the 7 most important characteristics from the list and (5) Report their acceptability and stated preference ranking between the three treatment options. RESULTS: Twenty women and 7 men with a mean age of 65 (range 51-85 years) participated in the focus groups. Twenty-four treatment characteristics were identified through focus groups and literature review. Efficacy, safety, out-of-pocket costs, strength of evidence and the option to self-administer were ranked as the most important attributes. The majority of patients stated preference for a daily sMTS if prescribed by their doctor. CONCLUSIONS: This study revealed that efficacy, safety, costs, and convenience are important attributes of osteoporosis treatment for US patients at high risk for fractures when choosing between anabolic therapies, with a high stated preference for sMTS.

Keepers of the House: A documentary.

BACKGROUND: Our documentary, Keepers of the House, highlights ways that hospital housekeepers, typically unnoticed care team members, provide emotional support for patients and their families. This film addresses a gap in education by emphasizing the importance of valuing and reflecting on the unique lived experiences of others. APPROACH: We created this documentary to expose students to the experiences and perceptions of hospital housekeepers. A focus group with six hospital housekeepers informed an interview script for the film's creation. Nine additional housekeepers were then interviewed, which developed into a 15-min documentary. Healthcare students and educators from five disciplines viewed the documentary during their institution's Medical Education Day. EVALUATION: To expose students and educators to housekeepers' experiences, we designed our post-viewing survey to address whether the housekeepers' stories impacted their understanding of the role and value of these workers. Viewers were surprised by the depth and breadth of patient-housekeeper interactions, the trauma housekeepers experienced from patient loss and the pride housekeepers take in their work. The stories that touched the viewers varied but centred on connections between housekeepers and patients. Lessons learned focused on recognizing the contributions of unseen team members. IMPLICATIONS: This innovative documentary amplifies the perspectives of voices rarely heard in healthcare. We aim to use this film, alongside its associated learning session, in education and grand round settings to foster discussion around empathy, valuing underrecognised team members and applying these insights in practice. This work can be disseminated to other institutions, further amplifying underrepresented narratives in healthcare.

Abaloparatide Real-World Patient Experience Study.

Despite the availability of various osteoporosis treatments, adherence remains suboptimal. One contributing factor may be patient experience with therapy. This US, multicenter, combined retrospective chart review and patient questionnaire study included postmenopausal women at high risk for fracture and is the first study to describe real-world patient experience with abaloparatide (ABL) injection. Eight geographically diverse secondary care sites in the United States participated (n = 193). Mean ± SD age was 67.4 ±8.62 years. Most patients (86%) were satisfied with the ABL regimen, especially with ease of preparation (82%), ease of storage (87%), and storage convenience (89%), an attribute 83% of the patients thought was important. The majority of patients reported complete satisfaction with the ABL regimen allowing for their ability to conduct daily activities (85%) and convenience to fit into their daily schedule (84%). All reported taking ABL as directed, by injection in the lower abdomen, and 83% of patients reported medium or high adherence. Patients were satisfied with the needle size (76% completely satisfied), and 93% reported never deliberately missing a dose. Although injecting medication (18%) and higher out-of-pocket costs (17%) were deemed the most bothersome attributes, the majority (69%) noted their healthcare team understands how osteoporosis impacts their lives. In multivariable analyses, ease of preparation (OR = 2.62; 95% CI, 1.01-6.81; p = 0.048) and fracture history (OR = 1.72; 95% CI, 1.03-2.86; p = 0.037) were significantly associated with overall satisfaction. Ease of preparation was a predictor of higher satisfaction with treatment convenience (coefficient = 13.60; 95% CI, 8.08-19.12; p = 0.00). Remembering to take the medication was a significant predictor of self-reported adherence (OR = 16.66; 95% CI, 3.30-84.24; p = 0.001). In conclusion, the majority of patients were satisfied with ABL and found it convenient/easy to prepare and store. High self-reported adherence may be associated with positive patient experience including ease of use and adequate support from healthcare providers. © 2020 The Authors. JBMR Plus published by Wiley Periodicals LLC. on behalf of American Society for Bone and Mineral Research.

Influence of Caretakers' Health Literacy on Delays to Traumatic Brain Injury Care in Uganda.

Background: Traumatic brain injury (TBI) is a life-altering condition, and delays to care can significantly impact outcomes. In Uganda, where nurse shortages are prevalent, patients' family members are the primary caretakers of these patients and play an important role in ensuring patients' access to timely care. However, caretakers often have little or no knowledge of appropriate patient care. Caretakers' ability to navigate the healthcare system and find and use health information to support their patients can impact delays in seeking, reaching, and receiving care. Objectives: This study seeks to determine the factors that impact TBI patient caretakers' health literacy and examine how these factors influence delays in care. Methods: This study was carried out in the Mulago National Referral Hospital neurosurgical ward, where 27 adult caretakers were interviewed using semi-structured, in-depth, qualitative interviews. "The Three Delay Framework" was utilized to understand participants' experiences in seeking, reaching, and receiving care for TBI patients. Thematic content analysis and manual coding was used to analyze interview transcripts and identify overarching themes in participant responses. Findings: The main health literacy themes identified were Extrinsic, Intrinsic and Health System Factors. Nine sub-themes were identified: Government Support, Community Support, Financial Burdens, Lack of Medical Resources, Access to Health Information, Physician Support, Emotional Challenges, Navigational Skills, and Understanding of Health Information. These components were found to influence the delays to care to varying degrees. Financial Burdens, Government Support, Emotional Challenges, Physician Support and Lack of Medical Resources were recurring factors across the three delays. Conclusion: The health literacy factors identified in this study influence caretakers' functional health literacy and delays to care in a co-dependent manner. A better understanding of how these factors impact patient outcomes is necessary for the development of interventions targeted at improving a caretaker's ability to maneuver the healthcare system and support patients in resource-poor settings.

Medication Decision-making in Osteoporosis: Can We Explain Why Patients Do Not Take Their Osteoporosis Medications?

Patients at high risk of fracture often do not take medication for osteoporosis. Recent literature may give us some insights into why patients at high risk of fracture do not take medications for osteoporosis.

Postmenopausal osteoporosis.

Osteoporosis is a metabolic bone disorder that is characterized by low bone mass and micro-architectural deterioration of bone tissue. Fractures of the proximal femur, the vertebrae and the distal radius are the most frequent osteoporotic fractures, although most fractures in the elderly are probably at least partly related to bone fragility. The incidence of fractures varies greatly by country, but on average up to 50% of women >50 years of age are at risk of fractures. Fractures severely affect the quality of life of an individual and are becoming a major public health problem owing to the ageing population. Postmenopausal osteoporosis, resulting from oestrogen deficiency, is the most common type of osteoporosis. Oestrogen deficiency results in an increase in bone turnover owing to effects on all types of bone cells. The imbalance in bone formation and resorption has effects on trabecular bone (loss of connectivity) and cortical bone (cortical thinning and porosity). Osteoporosis is diagnosed using bone density measurements of the lumbar spine and proximal femur. Preventive strategies to improve bone health include diet, exercise and abstaining from smoking. Fractures may be prevented by reducing falls in high-risk populations. Several drugs are licensed to reduce fracture risk by slowing down bone resorption (such as bisphosphonates and denosumab) or by stimulating bone formation (such as teriparatide). Improved understanding of the cellular basis for osteoporosis has resulted in new drugs targeted to key pathways, which are under development.

Association Between Gastrointestinal Events and Health Care Resource Utilization Among Patients with Osteoporosis: Analysis of a U.S. Managed Care Population.

BACKGROUND: Among patients on osteoporosis therapy, including oral bisphosphonates (BIS), upper gastrointestinal (GI) conditions have been linked with lower adherence to treatment and increased treatment discontinuation in clinical practice. Patients who are nonadherent to treatment have a higher risk of osteoporotic fractures and, consequently, have greater use of health care services. The burden of upper gastrointestinal events on health care resource utilization (HCRU) among women initiating oral BIS has not been well investigated. OBJECTIVE: To examine the association of upper GI events and HCRU in women initiating oral BIS.  METHODS: Using a U.S. national claims database, this retrospective study identified women aged ≥ 55 years who were prescribed oral BIS during 2001-2011 and had no history of GI events 12 months prior to treatment initiation. Patients with medical claims for an upper GI event ≤ 4 months posttreatment initiation were cases; all others were controls. The date of the first upper GI event among cases and a randomly assigned date ≤ 4 months posttreatment initiation among controls was the index date. Cases were matched 1:1 to controls by propensity scores derived from logistic regression of pre-index patient characteristics. Outcomes were all-cause and osteoporosis (OP)-related HCRU in the 6-month post-index period. Differences were assessed using McNemar's test. RESULTS: Of the 62,863 eligible patients, 4,751 (7.6%) experienced an upper GI event ≤ 4 months posttreatment initiation (cases); 4,739 cases were matched with 4,739 controls. Compared with controls, cases had higher rates of all-cause HCRU (outpatient: 99.3% vs. 87.8%; inpatient: 20.2% vs. 6.4%; emergency room [ER]: 12.5% vs. 7.4%; all P less than 0.0001) and OP-related HCRU (outpatient: 24.6% vs. 18.2%; inpatient: 3.4% vs. 1.0%; ER: 0.7% vs. 0.4%; all P less than 0.05). CONCLUSIONS: Patients with upper GI events had higher rates of all-cause and OP-related health care utilization. Upper GI events may pose an incremental HCRU burden among patients initiating BIS.

Psychometric properties of the osteoporosis assessment questionnaire (OPAQ) 2.0: results from the multiple outcomes of raloxifene evaluation (MORE) study.

BACKGROUND: We explored psychometric properties of the Osteoporosis Assessment Questionnaire 2.0 in terms of reliability, validity, and responsiveness with generic, clinical, demographic, and preference-based data collected from a population of postmenopausal women with osteoporosis. METHODS: The Multiple Outcomes of Raloxifene Evaluation study was a randomized, placebo-controlled, multinational clinical trial evaluating efficacy and safety of raloxifene. The Osteoporosis Assessment Questionnaire 2.0, a generic quality of life measure (Nottingham Health Profile), and a preference-based measure (Health Utilities Index) were administered at baseline and annually. Psychometric properties of the 14 Osteoporosis Assessment Questionnaire 2.0 domains were evaluated by standard statistical techniques. RESULTS: This study included a subset of 1477 women from the Multiple Outcomes of Raloxifene Evaluation study population completing the questionnaires. Mean (standard deviation) age was 68.4 (6.8) years. Prevalent vertebral fractures were found in 70% (n =1038) of women. Internal consistency was >0.7 in 9 Osteoporosis Assessment Questionnaire 2.0 domains. Correlations were moderate and significant for similar Osteoporosis Assessment Questionnaire 2.0 domain scores, Nottingham Health Profile domains, and Health Utilities Index scores. All but 2 Osteoporosis Assessment Questionnaire 2.0 domains distinguished between patients with or without prevalent vertebral fractures and detected worsening with increased number of vertebral fractures. Women with ≥ 1 incident vertebral fracture generally had a greater worsening in Osteoporosis Assessment Questionnaire 2.0 scores (excluding social activity and support of family and friends) from baseline to study endpoint compared with women without incident vertebral fractures. CONCLUSIONS: Most domains in the Osteoporosis Assessment Questionnaire 2.0 demonstrated robust psychometric properties; however, several domains not showing these criteria may need to be reassessed and removed for a potentially shorter and validated version of the Osteoporosis Assessment Questionnaire.

Validation of the Osteoporosis-Specific Morisky Medication Adherence Scale in long-term users of bisphosphonates.

PURPOSE: To examine the psychometric properties and validity of the 8-item Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS-8) in postmenopausal women prescribed bisphosphonates (BPs) for at least 15 months. METHODS: A random sample of women aged ≥55 years with osteoporosis prescribed daily or weekly BPs was identified. Pharmacy fill data were extracted to calculate the medication possession ratio (MPR). Eligible women were stratified by low (<0.50), medium (0.50-0.79), or high (≥0.80) MPR, with the a priori goal of recruiting 133 participants in each group. OS-MMAS-8 scores can range from 0 to 8 and were categorized as low (<6), medium (6 to <8), and high (8) adherence. Internal consistency reliability (Cronbach's alpha), test-retest reliability [intraclass correlation coefficients (ICCs)] and convergent validity (correlating OS-MMAS-8 with MPR and other self-reported measures) were assessed. RESULTS: A total of 400 women out of 449 respondents reported that they were still taking their BPs at the time of the survey and completed OS-MMAS-8. Overall, 38.5, 34.3, and 27.3% of participants had low, medium, and high OS-MMAS-8 scores, respectively. The mean (SD) MPRs according to OS-MMAS-8 scores (<6, 6 to <8 and 8) were 56.9 (22.6), 69.0 (24.9), and 76.7 (26.4), respectively. The correlation between OS-MMAS-8 and MPR was 0.36; p < 0.0001. Cronbach's alpha was 0.74, and the ICC was 0.83 (95% CI 0.76-0.88). CONCLUSIONS: OS-MMAS-8 has acceptable psychometric properties for assessing medication adherence in postmenopausal women prescribed therapy for osteoporosis. Additional studies are needed to investigate the psychometric properties of OS-MMAS-8 in other settings and populations.

Use of health-related quality of life measures to predict health utility in postmenopausal osteoporotic women: results from the Multiple Outcomes of Raloxifene Evaluation study.

BACKGROUND: The aim of this study is to examine the associations between health utility (HU), health-related quality of life (HRQoL), and patient characteristics in postmenopausal osteoporotic (PMO) women. METHODS: Baseline data from a subsample of 1,245 participants of the Multiple Outcomes of Raloxifene Evaluation study, a randomized, placebo-controlled, multinational clinical trial to evaluate the safety and efficacy of raloxifene, were analyzed. The study cohort included 694 participants from non-European Union (non-EU) countries and 551 participants from EU countries. All participants with complete baseline HU and HRQoL assessments were included in the following analyses: 1) HU (HUI or EQ-5D) and HRQoL (QualEFFO or OPAQ and NHP) associations; 2) HU variability explained by HRQoL domains; and 3) the percentage of HU variability explained by statistically significant (p < 0.05) HRQoL domains, after adjusting for baseline characteristics. RESULTS: Several domains were significantly associated with HU scores. HU variance was well explained (41% to 61%) by 4 to 6 (p < 0.05) significant HRQoL domains. After controlling for baseline characteristics, 48% to 64% of the HU variance was well explained by 5 to 7 significant (p < 0.05) HRQoL domains. Additional trend analyses detected statistically significant decreases in HRQoL and HU scores with an increased number of vertebral and non-vertebral fractures. CONCLUSIONS: Both disease-targeted and generic HRQoL domains were well correlated with HU. A large percentage (48% to 64%) of the HU variance was explained by HRQoL, after adjusting for baseline characteristics. Both disease-targeted and generic HRQoL measures were significant predictors of HU. HRQoL and HU scores decreased with increased vertebral and non-vertebral fractures.

Psychometric properties of the Osteoporosis-specific Morisky Medication Adherence Scale in postmenopausal women with osteoporosis newly treated with bisphosphonates.

BACKGROUND: Poor adherence to oral osteoporosis medications is common. Strategies for improving adherence begin with identification of the problem. The 8-item Morisky Medication Adherence Scale for self-reported adherence to antihypertensive medications was modified for assessing adherence to oral osteoporosis medications. An evaluation of the measurement properties of the Osteoporosis-Specific Morisky Medication Adherence Scale (OS-MMAS) was needed. OBJECTIVE: To examine the psychometric properties of the OS-MMAS in women with postmenopausal osteoporosis. METHODS: Five hundred women aged 55 years and older with osteoporosis who were newly prescribed daily or weekly oral bisphosphonates between May 15, 2010, and August 15, 2010, were randomly selected from Kaiser Permanente Southern California, a large integrated health care delivery system, and mailed a self-administered survey that included the 8-item OS-MMAS, Self-Efficacy for Appropriate Medication Use Scale (SEAMS), Beliefs about Medicines Questionnaire (BMQ), Treatment Satisfaction Questionnaire for Medication (TSQM), Gastrointestinal Symptom Rating Scale (GSRS), and 12-item Short-Form Health Survey (SF-12v2). OS-MMAS scores can range from 0 to 8, with higher scores indicating better medication adherence. Internal consistency reliability was evaluated using Cronbach α coefficient. Test-retest reliability was assessed using intraclass correlation coefficients (ICCs) in a subset of 102 participants. Construct validity was assessed using confirmatory factor analysis and correlations between OS-MMAS and related measures. RESULTS: Of 197 participants, 150 reported that they were still taking their bisphosphonate at the time of the survey and completed the OS-MMAS. Overall, 30.7%, 32.7%, and 36.7% had low, medium, and high OS-MMAS scores (<6, 6 to <8, and 8, respectively). Cronbach α was 0.82 and the ICC was 0.77. Convergent validity was supported by significant correlations with SEAMS, BMQ necessity, and TSQM scores. In confirmatory factor analysis, a single-factor scale was supported. CONCLUSIONS: The OS-MMAS showed strong psychometric properties with good reliability and construct validity and may provide a valuable assessment of self-reported medication adherence in women newly prescribed oral osteoporosis medications.

Development, reliability, and validity of a new Preference and Satisfaction Questionnaire.

OBJECTIVES: Existing questionnaires that assess preference and/or satisfaction with postmenopausal bone loss treatments were reviewed and determined to be inadequate for the assessment of an oral pill versus a subcutaneous injection. The Preference and Satisfaction Questionnaire (PSQ) was developed to assess preference, satisfaction, and bother with a weekly oral tablet versus a once every 6 months subcutaneous injection for treatment of postmenopausal bone loss. METHODS: Questions were developed based on literature review and expert input. Content validity of the PSQ in this patient population was assessed among current or previous bisphosphonate users in group interviews, and item comprehension and readability were also evaluated. Reliability, validity, and structure of the questionnaire were assessed in two phase 3 randomized clinical trials. RESULTS: Twenty-four women participated in cognitive interviews and found the PSQ understandable and acceptable. Subsequently, 1583 trial participants took the PSQ. Interitem correlations, ranging from 0.50 to 0.97 for preference items, 0.85 to 0.94 for pill-satisfaction items, and 0.84 to 0.92 for injection-satisfaction items, and a well-fitting confirmatory factor analysis (root mean square error of approximation 0.04, nonnormed fit index 0.99, and root mean square residual 0.08) supported the structure of the instrument. Cronbach's alpha reliability values for pill satisfaction, injection satisfaction, pill bother, and injection bother were 0.93, 0.89, 0.82, and 0.61, respectively. Discriminative validity was indicated with better satisfaction and bother scores being related to adherence and the absence of adverse events. CONCLUSIONS: The PSQ is a valid and reliable measure and may be a valuable tool to assess patient preference and satisfaction with a weekly oral tablet and 6-month subcutaneous injection for postmenopausal bone loss.

Factors Associated with Persistence with Teriparatide Therapy: Results from the DANCE Observational Study.

Purpose. Determine patient-reported reasons for discontinuation with teriparatide. Methods. Patients taking teriparatide in a multicenter, prospective, and observational study were given three questionnaires: baseline, follow-up questionnaire 1 (QF1, 2 to 6 months), and follow-up questionnaire 2 (QF2, 12 months). Discontinuation reported at QF1 and QF2 was defined as "early" and "late," respectively, and remaining patients were considered persistent. Cochran-Armitage trend test was used to identify factors associated with discontinuation. Results. Side effects, concern about improper use, injection difficulties, and several patient-perceived physician issues were associated with early discontinuation. Low patient-perceived importance of continuing treatment, side effects, difficulty paying, and low patient-perceived physician knowledge were associated with late discontinuation. The most common specific reasons selected for discontinuing treatment were "concerns about treatment outweighing the benefits" (n = 53) and "difficulty paying" (n = 47). Conclusions. Persistence with teriparatide is dependent on managing side effects, addressing financial challenges, proper training, and obtaining support from the healthcare provider.

Growing up with sickle cell disease: a pilot study of a transition program for adolescents with sickle cell disease.

We implemented the Duke Sickle Cell Disease (SCD) Transition Program for adolescents with SCD and investigated the knowledge about SCD; concerns and emotions about transitioning; and the initial impact of the Transition Program. Thirty-three adolescents participated in the initial study. Gaps in knowledge included ethnicities affected by SCD and inheritance of SCD. Adolescents were primarily concerned about transferring to a new medical team. There was a mix of both positive and negative emotions that varied over time. Overall, we have identified educational gaps and concerns and emotions about transitioning, which we will address through the Duke SCD Transition Program.

Understanding patient compliance and persistence with osteoporosis therapy.

Chronic non-terminal diseases, including postmenopausal osteoporosis, are associated with poor treatment compliance and persistence. The longer a patient with osteoporosis complies and persists with treatment, the lower the risk of fracture. Retrospective studies with emphasis on real-world data have led to a greater understanding of the factors affecting medication compliance and persistence, and their association with improved treatment outcomes. However, these data do not contain information about patient choices of medication or patient commitment to particular medication regimens. Patient preferences can affect compliance and persistence behaviours. While recent evidence questions the importance of dosing regimen in patient preferences, other recent data show that medication efficacy and safety remain the most important determinants of patient preference. Informed patient decision making about treatment options, adverse effects and outcomes can have a beneficial impact on medication-taking behaviour. Healthcare professionals play a crucial role in the management of factors associated with poor compliance and persistence with osteoporosis therapies. Education about disease consequences and differences among treatment options, as well as treatment monitoring and positive reinforcement, are crucial to improving medication compliance and persistence in osteoporotic patients.

Older men's explanatory model for osteoporosis.

PURPOSE: To explore the nature of men's experiences of osteoporosis by developing an understanding of men's explanatory models. DESIGN AND METHODS: This descriptive study invited community-residing male osteoporosis patients aged 50+ to participate in interviews about osteoporosis. Participants were recruited from a hospital-affiliated bone clinic. Men completed a questionnaire on demographic, medication, and fracture-related information, and descriptive statistics were calculated using Statistical Package for the Social Sciences. Interviews elicited the 5 domains of men's explanatory model (Kleinman, 1987) and open-ended information regarding men's experiences living with this disorder. Narrative data were analyzed both for content and inductively. RESULTS: Men's narratives demonstrate that an osteoporosis diagnosis is accompanied by negative psychosocial sequelae in this population. Men defined it as a disease of the bone that may increase the likelihood of fracture and that may cause pain. Participants reported that osteoporosis is diagnosed by bone mineral density (BMD) score and that disease progression is measured by a decrease in BMD and an increase in pain or new fractures. Men described a reluctance to take medications, dissatisfaction with side effects, and a perception that osteoporosis treatment in men had little basis in long-term medication efficacy or safety data. They viewed osteoporosis as a degenerative chronic disease with an overall stable course. IMPLICATIONS: Participants' explanatory models for osteoporosis are substantively different than clinical models. These differences provide a foundation for exploring the importance of gender to osteoporosis outcomes, a context for making sense of men's bone health behavior, and a clear case for an increase in advocacy and educational efforts for men who have or are at risk for osteoporosis.

Compliance and persistence with osteoporosis medications: a critical review of the literature.

It is widely acknowledged that compliance and persistence with oral osteoporosis medications, particularly with bisphosphonates, is poor. Several excellent reviews have been written on compliance and persistence with osteoporosis medications and have discussed improvements seen with extended dosing intervals. This review begins with studies on extended dosing intervals to examine the limitations of administrative claims data. It also looks at compliance and persistence across multiple medical conditions, examining the importance of prescription fulfillment, intentional choice, causation and possible interventions.

Weekly versus monthly drug regimens: 1-year compliance and persistence with bisphosphonate therapy.

OBJECTIVE: To determine compliance and persistence with weekly risedronate and monthly ibandronate therapy. RESEARCH DESIGN AND METHODS: The IMS longitudinal prescription database was used to evaluate compliance (mean medication possession ratio), persistence (days until a gap >90 days between prescriptions occurred) and cumulative drug availability (ratio of drug supply and days between first fill date and the end of the study) among patients taking weekly risedronate or monthly ibandronate over a 12-month period using three retrospective cohorts: overall sample, new to osteoporosis therapy, and new to osteoporosis therapy after initial market availability. Comparisons were made between drug groups for each measure. RESULTS: Compliance was significantly different for the overall sample (80.15 +/- 18.90% for risedronate vs. 74.68 +/- 22.56% for ibandronate; p < 0.0001), and marginally different during the initial post-marketing year (p = 0.091), but not for patients new to therapy (p = 0.693). Persistence was significantly different for the overall sample (250.04 +/- 132.34 days for risedronate vs. 151.54 +/- 137.24 days for ibandronate; p < 0.0001), for patients new to therapy (154.38 +/- 135.29 days for risedronate vs. 133.33 +/- 130.36 days for ibandronate; p < 0.0001), and after initial market availability (165.00 +/- 141.58 days for risedronate vs. 133.33 +/- 130.36 days for ibandronate; p < 0.0001). Mean cumulative drug availability was significantly different for the overall sample (64.54 +/- 29.86% for risedronate vs. 43.38 +/- 32.96% for ibandronate; p < 0.0001), for patients new to therapy (40.34 +/- 31.84% for risedronate vs. 36.05 +/- 31.09% for ibandronate; p < 0.0001), and after initial market availability (43.17 +/- 33.34% for risedronate vs. 36.05 +/- 31.09% for ibandronate; p < 0.0001). CONCLUSIONS: Patient compliance, persistence and cumulative drug availability were similar for monthly ibandronate and weekly risedronate dosing. Interpretations from this study are limited by assumptions of persistence based on initial drug dosing and selected refill gap length measured. Furthermore, comparisons with earlier studies are difficult, due to differences in definitions of compliance and persistence. Further studies are needed to explore factors affecting patterns of medication use, particularly the effects of patient preference, acceptance, and patient education on compliance and persistence.