The Design and Validation of a New Algorithm to Identify Incident Fractures in Administrative Claims Data.

Our study validated a claims-based algorithm for the identification of incident and recurrent fractures in administrative data. We used Centers for Medicare and Medicaid (CMS) claims from 2005 to 2014 linked to the Reasons for Geographic and Racial Differences in Stroke (REGARDS) database. Case qualifying (CQ) fractures were identified among participants with ≥12 months of fee-for-service coverage before first fracture claim and ≥6 months after. Recurrent fractures were defined as the first CQ fracture that occurred following a clean period of at least 90 days from the last claim associated with the preceding incident fracture. We used medical records (discharge summary, imaging, and surgical report) to adjudicate fractures. We calculated positive predictive values (PPVs) for incident and recurrent fractures. Our study was not designed to assess the algorithm sensitivity or negative predictive value. We identified 2049 potential incident fractures from claims among 1650 participants. Record retrieval was attempted for 728 (35.5%) suspected incident fractures (prioritizing more recent CQ fractures associated with osteoporosis, but without explicitly requiring any osteoporosis ICD-9 diagnosis code). Our final sample included 520 claims-identified fractures with medical records, of which 502 (96.5%) were confirmed. The PPVs (95% CI) of the hip, wrist, humerus, and clinical vertebra-all exceeded 95%. We identified 117 beneficiaries with 292 ≥2 CQ fracture episodes at the same site, and attempted retrieval on 105 (36.0%) episodes. Our analytic sample included 72 (68.5%) CQ episodes from 33 participants. The PPVs for identifying recurrent clinical vertebral, hip/femur, and nonvertebral fractures with a 90-day clean period exceeded 95%. Although we could not ascertain sensitivity, our updated fracture identification algorithms had high PPV for the identification of incident and recurrent fractures of the same site. Although medical record review and clinical adjudication remain a gold standard, our claims-based algorithm provides an alternative approach to fracture ascertainment when high PPV is desired. © 2019 American Society for Bone and Mineral Research.

Race Plays a Role in the Knowledge, Attitudes, and Beliefs of Women with Osteoporosis.

Using a concurrent mixed methods design, we investigated how knowledge, attitudes, values, and beliefs among women with osteoporosis can explain racial disparities in bone health. We recruited African American and White women ≥ 65 years of age with osteoporosis to participate in focus groups. We quantitatively compared scores of the "Osteoporosis & You" knowledge scale and each domain (internal, powerful others, and chance) of the Multidimensional Health Locus of Control scale by race using t tests. We qualitatively explored potential racial differences in attitudes, values, and beliefs in the domains: (1) osteoporosis and bone health concerns, (2) knowledge about osteoporosis, (3) utilization of medical services for osteoporosis, (4) facilitators of osteoporosis prevention activities, and (5) barriers to osteoporosis prevention activities. A total of 48 women (White: 36; African American: 12) enrolled in the study. White women had a mean (SD) of 7.8 (0.92), whereas African American women score a 6.6 (2.6) (p = 0.044) out of 10 on the Osteoporosis & You Scale. The powerful others domain was significantly higher among African American for both general and bone health [General Health - African American: 26.7 (5.9) vs. White: 22.3 (3.8); p = 0.01]. Qualitative thematic analysis revealed differences by race in knowledge, types of physical activity, coping with comorbidities, physician trust, religion, and patient activation. Using both quantitative and qualitative methods, our study identified racial differences in knowledge, attitudes, and beliefs in women with osteoporosis that could result in racial disparities in bone health, indicating the need to improve education and awareness about osteoporosis in African American women.

Using tablet computers compared to interactive voice response to improve subject recruitment in osteoporosis pragmatic clinical trials: feasibility, satisfaction, and sample size.

INTRODUCTION: Pragmatic clinical trials (PCTs) provide large sample sizes and enhanced generalizability to assess therapeutic effectiveness, but efficient patient enrollment procedures are a challenge, especially for community physicians. Advances in technology may improve methods of patient recruitment and screening in PCTs. Our study looked at a tablet computer versus an integrated voice response system (IVRS) for patient recruitment and screening for an osteoporosis PCT in community physician offices. MATERIALS AND METHODS: We recruited women ≥ 65 years of age from community physician offices to answer screening questions for a hypothetical osteoporosis active comparator PCT using a tablet computer or IVRS. We assessed the feasibility of these technologies for patient recruitment as well as for patient, physician, and office staff satisfaction with the process. We also evaluated the implications of these novel recruitment processes in determining the number of primary care practices and screened patients needed to conduct the proposed trial. RESULTS: A total of 160 women (80% of those approached) agreed to complete the osteoporosis screening questions in ten family physicians' offices. Women using the tablet computer were able to complete all screening questions consistently and showed a nonsignificant trend towards greater ease of use and willingness to spend more time in their physician's office compared to those using IVRS. Using the proportion of women found to be eligible in this study (almost 20%) and other eligibility scenarios, we determined that between 240 and 670 community physician offices would be needed to recruit ample patients for our hypothetical study. CONCLUSION: We found good satisfaction and feasibility with a tablet computer interface for the recruitment and screening of patients for a hypothetical osteoporosis PCT in community office settings. In addition, we used this experience to estimate the number of research sites needed for such a study.

Identification and validation of vertebral compression fractures using administrative claims data.

INTRODUCTION: Vertebral compression fractures (VCFs) are the most common type of osteoporotic fracture. Administrative claims data might be useful to identify VCFs, but this approach to case finding has received limited evaluation. METHODS: Using the administrative claims databases of a large regional US health care organization, we identified adults with a claim with a VCF diagnosis code from January 2003 to June 2004 and excluded persons with malignancy. We examined the positive predictive values (PPV) of several claims algorithms to correctly identify any confirmed (prevalent or incident) VCF, and separately, incident VCFs. RESULTS: A total of 259 persons were identified with a VCF suspected based on their administrative claims data. A claims algorithm that required a VCF diagnosis on any claim had a PPV to identify any confirmed VCF of 87% (95% confidence interval (CI), 82-91%). The PPV of this algorithm to identify a confirmed incident VCF was 46% (95% CI, 37-54%). An algorithm that required a spine imaging test followed by a physician visit with a VCF code within 10 days, or a hospitalization with a primary diagnosis code, had higher PPVs (PPV = 93%; 95% CI, 87-98% for any confirmed VCF; PPV = 61%; 95% CI, 49-74% for incident VCFs). CONCLUSIONS: A simple case finding approach to identify VCFs using administrative claims data can identify prevalent VCFs with high accuracy but misclassified more than half of incident VCFs. A more complex claims algorithm may be used but still will result in some misclassification of incident VCFs.

Treatment with alendronate plus calcium, alendronate alone, or calcium alone for postmenopausal low bone mineral density.

OBJECTIVE: Bisphosphonates such as alendronate are widely used for postmenopausal osteoporosis. Supplemental calcium is also generally recommended. This trial directly compares alendronate to supplemental calcium and examines the effect of calcium supplementation on alendronate treatment. METHODS: This 2-year, randomized, double-blind, multicenter trial enrolled healthy, postmenopausal women with low bone mineral density (BMD). Patients with a dietary calcium intake > or = 800 mg/day received daily vitamin D 400 IU and alendronate 10 mg/calcium-placebo, alendronate 10 mg/elemental calcium 1000 mg, or alendronate-placebo/calcium 1000 mg (2:2:1). Endpoints included BMD, bone turnover markers (BTMs), and adverse events. RESULTS: Randomized patients (N = 701) were an average of 20.4 years postmenopausal. After 24 months, increases in lumbar spine BMD differed significantly between patients receiving calcium alone (0.8%) and either alendronate alone (5.6%) or alendronate + calcium (6.0%) (p < 0.001). Significant differences were also seen at the trochanter and femoral neck (p < 0.001). BTMs were significantly lower with alendronate-containing treatments than calcium alone (p < 0.001). Addition of calcium supplementation to alendronate did not significantly increase BMD compared to alendronate alone (p = 0.29 to 0.97), but did result in a statistically significant, though small, additional reduction in urinary NTx. Adverse events were similar among treatment groups. Limitations include no assessment of vitamin D levels and a discontinuation rate of approximately 30%, although discontinuation rates were similar among treatment groups. CONCLUSIONS: In postmenopausal women with a daily intake of > or =800 mg calcium and 400 IU vitamin D, 24-month treatment with alendronate 10 mg daily with or without calcium 1000 mg resulted in significantly greater increases in BMD and reduction of bone turnover than supplemental calcium alone. Addition of supplemental calcium to alendronate treatment had no effect on BMD and resulted in a small, though statistically significant, additional reduction in NTx.

Challenges in improving the quality of osteoporosis care for long-term glucocorticoid users: a prospective randomized trial.

BACKGROUND: In light of widespread undertreatment for glucocorticoid-induced osteoporosis (GIOP), we designed a group randomized controlled trial to increase bone mineral density (BMD) testing and osteoporosis medication prescribing among patients receiving long-term glucocorticoid therapy. METHODS: Using administrative databases of a large US health plan, we identified physicians who prescribed long-term glucocorticoid therapy to at least 3 patients. One hundred fifty-three participating physicians were randomized to receive a 3-module Web-based GIOP intervention or control course. Intervention modules focused on GIOP management and incorporated case-based continuing medical education and personalized audit and feedback of GIOP management compared with that of the top 10% of study physicians. In the year following the intervention, we compared rates of BMD testing and osteoporosis medication prescribing between intervention and control physicians. RESULTS: Following the intervention, intent-to-treat analyses showed that 78 intervention physicians (472 patients) vs 75 control physicians (477 patients) had similar rates of BMD testing (19% vs 21%, P = .48; rate difference, -2%; 95% confidence interval [CI], -8% to 4%) and osteoporosis medication prescribing (32% vs 29%, P = .34; rate difference, 3%; 95% CI, -3% to 9%). Among 45 physicians completing all modules (343 patients), intervention physicians had numerically but not significantly higher rates of BMD testing (26% vs 16%, P =.04; rate difference, 10%; 95% CI, 1%-20%) and bisphosphonate prescribing (24% vs 17%, P =.09; rate difference, 7%; 95% CI, -1% to 16%) or met a combined end point of BMD testing or osteoporosis medication prescribing (54% vs 44%, P =.07; rate difference, 10%; 95% CI, -1% to 21%) compared with control physicians. CONCLUSIONS: In the main analysis, a Web-based intervention incorporating performance audit and feedback and case-based continuing medical education had no significant effect on the quality of osteoporosis care. However, dose-response trends showed that physicians with greater exposure to the intervention had higher rates of GIOP management. New cost-effective modalities are needed to improve the quality of osteoporosis care.

Alendronic acid produces greater effects than risedronic acid on bone density and turnover in postmenopausal women with osteoporosis : results of FACTS -international.

BACKGROUND: The objective of the study was to evaluate the effects of alendronic acid once weekly relative to risedronic acid once weekly on bone mineral density (BMD), markers of bone turnover and tolerability in the treatment of osteoporosis in postmenopausal women. METHODS: This was a randomised, double-masked, double-dummy multicentre international study (75 centres in 27 countries in Europe, the Americas and Asia-Pacific). A total of 1303 women were screened and 936 with low bone density (T-score < or = -2.0 at the spine, hip trochanter, total hip or femoral neck) were randomised; 91% (n = 854) completed the study. Patients were randomised to treatment with either active alendronic acid 70 mg weekly (Fosamax) and placebo identical to risedronic acid weekly or active risedronic acid 35 mg weekly (Actonel) and placebo identical to alendronic acid weekly for 12 months. The primary efficacy endpoint was the percentage change from baseline in hip trochanter BMD at 12 months. Secondary endpoints included the percentage change from baseline in lumbar spine, total hip and femoral neck BMD; biochemical markers of bone turnover (including serum bone-specific alkaline phosphatase [BSAP] and urinary type I collagen N-telopeptides [NTx]); and safety and tolerability as assessed by reporting of adverse experiences. RESULTS: Alendronic acid produced greater increases in BMD than did risedronic acid at 12 months at all sites measured. Mean percentage increases from baseline in hip trochanter BMD at month 12 were 3.56% and 2.71% in the alendronic acid and risedronic acid groups, respectively (treatment difference [95% CI]: 0.83% [0.22, 1.45; p = 0.008]). Mean percentage increases from baseline were greater with alendronic acid than risedronic acid at the lumbar spine, total hip and femoral neck BMD at month 12 (p = 0.002, p < 0.001, p = 0.039, respectively). Increases in BMD with alendronic acid compared with risedronic acid were also significantly greater at 6 months at the trochanter and total hip. There was a greater reduction in bone turnover with alendronic acid compared with risedronic acid: NTx decreased 58% with alendronic acid compared with 47% with risedronic acid at 12 months (p < 0.001); and BSAP decreased 45% with alendronic acid compared with 34% with risedronic acid at 12 months (p < 0.001). Overall tolerability and upper gastrointestinal tolerability were similar for both agents. CONCLUSIONS: Alendronic acid once weekly produced greater BMD increases at both hip and spine sites and greater reductions in bone turnover relative to risedronic acid once weekly. Both agents were well tolerated with no significant difference in upper gastrointestinal adverse experiences. Clinicians should consider these results when making treatment decisions for postmenopausal women with osteoporosis.

Patients with osteoporosis prefer once weekly to once daily dosing with alendronate.

OBJECTIVES: Once weekly dosing of alendronate has been shown to provide equivalent efficacy to once daily dosing for treatment of osteoporosis in postmenopausal women. Whether patients will prefer weekly dosing to daily dosing for a chronic condition such as osteoporosis has not been studied. The aim of this international study was to assess preference for the weekly or daily dosing regimen of alendronate among postmenopausal women with osteoporosis. METHODS: This randomised open-label crossover study was conducted at 45 study sites in 19 countries. Four hundred and six postmenopausal women with osteoporosis were assigned randomly to treatment with either alendronate 70 mg once weekly for 4 weeks followed by alendronate 10 mg once daily for 4 weeks or vice versa. The main outcome was the responses of the participants to the Dosing Regimen Questionnaire administered at the end of the study. RESULTS: Of the participants expressing a preference, 84% preferred the once weekly dosing regimen with alendronate to the once daily dosing regimen. In addition, the once weekly regimen was considered by 87% of the participants to be more convenient and was the regimen most of the participants (84%) would be more willing to take for a long period of time (P < 0.001 for each parameter). CONCLUSIONS: The majority of postmenopausal women with osteoporosis preferred the once weekly to the once daily dosing regimen of alendronate. Physicians should consider patient preference for dosing regimen when selecting the appropriate treatment for osteoporosis.

Alendronate prevents loss of bone density associated with discontinuation of hormone replacement therapy: a randomized controlled trial.

BACKGROUND: Many women using hormone replacement therapy (HRT) will discontinue HRT and lose its bone-protective effect. Methods to preserve bone density in these women need to be explored. This multicenter, international, randomized, blinded, 12-month study was conducted to assess the effect of alendronate sodium on bone density in women who had recently discontinued HRT. METHODS: The 144 postmenopausal women included in the study were diagnosed as having low bone mineral density (BMD) and had recently discontinued HRT. They were randomized to receive either a daily dose of 10 mg of alendronate sodium or matching placebo. The main outcome measures were spine, hip, and total body BMD; biochemical markers of bone turnover; and tolerability. RESULTS: Alendronate treatment was associated with a 2.3% mean increase (95% confidence interval [CI], 1.7%-3.0%) in spine BMD compared with a mean loss of 3.2% (95% CI, - 4.6% to - 1.7%) in patients receiving placebo, for a difference of 5.5% (95% CI, 4.2%-6.8%) between alendronate and placebo. Greater hip and total body BMD preservation was also observed with alendronate use. Bone turnover decreased significantly with alendronate (bone-specific alkaline phosphatase levels decreased by 20% and urinary N-telopeptide/creatinine ratio by 47%), but increased in the placebo group (by 18% and 36%, respectively). Alendronate was well tolerated, with no increase in adverse events compared with placebo. CONCLUSIONS: A high rate of bone loss was observed in the first 12 to 15 months after discontinuation of HRT in postmenopausal women with low BMD. Treatment with alendronate increased or maintained both spine and hip BMD and prevented the increase in bone resorption seen with withdrawal of HRT in this population.

Performance of risk indices for identifying low bone density in postmenopausal women.

OBJECTIVE: To examine the ability of 4 published osteoporosis risk indices to identify women with low bone density. SUBJECTS AND METHODS: Subjects included postmenopausal women 45 years and older consecutively recruited from US clinics, women from general practice centers in The Netherlands (age range, 50-80 years), women in the Rotterdam Study (The Netherlands) 55 years and older, and women aged 55 to 81 years old screened for a clinical trial of alendronate. Bone mineral density (BMD) was measured at the femoral neck or lumbar spine; T scores represent the number of SDs below the mean for young healthy women. One risk index was calculated from age and weight; the other risk indices included up to 4 additional variables obtained by questionnaire. We calculated the sensitivity and specificity for identifying women with BMD T scores of -2.5 or less or -2.0 or less in the US clinic sample and created 3 risk categories, using each of the 4 indices. RESULTS: Data were available for 1102 women from the US clinic sample, 3374 women in the Rotterdam Study, 23,833 women screened for a clinical trial of alendronate, and 4204 women from general practice centers in The Netherlands. Specificity for identifying BMD T scores of -2.5 or less ranged from 37% to 58% (depending on risk index) when sensitivity was approximately 90%. The prevalence of osteoporosis (defined as T scores < or = -2.5) differed widely across the 3 risk categories, ranging from 2% to 4% for the low-risk category to 47% to 61% for the high-risk category in the US clinic sample. For spine BMD in the US clinic sample, the prevalence of T scores of -2.5 or less ranged from 7% (low risk) to 38% (high risk). The large differences in prevalence across risk categories were consistent across the other 3 samples of postmenopausal women in the United States and The Netherlands for all 4 risk indices. CONCLUSIONS: We recommend measuring BMD in women who are classified as having an increased risk of osteoporosis by using any of these risk indices because all 4 indices appear to predict low bone mass equally well. The Osteoporosis Self-assessment Tool index is easiest to calculate and therefore may be most useful in clinical practice.

Alendronate improves bone mineral density in elderly women with osteoporosis residing in long-term care facilities. A randomized, double-blind, placebo-controlled trial.

BACKGROUND: Many elderly female residents of long-term care facilities have osteoporosis and could benefit from intervention to increase bone density. OBJECTIVE: To examine the efficacy and safety of alendronate for treatment of osteoporosis in elderly female residents of long-term care facilities. DESIGN: Multicenter, randomized, double-blind, placebo-controlled 2-year study. SETTING: 25 long-term care facilities. PATIENTS: 327 elderly women with osteoporosis. INTERVENTION: Patients were randomly assigned to receive alendronate, 10 mg/d, or placebo. All patients also received vitamin D, 400 IU/d, and some patients received supplemental calcium (total intake, approximately 1500 mg/d). MEASUREMENTS: Bone mineral density (BMD) of the spine and hip and biochemical markers of bone turnover. RESULTS: Alendronate produced significantly greater increases in BMD than did placebo (24-month differences: spine, 4.4% [95% CI, 3.3% to 5.5%]; femoral neck, 3.4% [CI, 2.3% to 4.4%]). Alendronate produced greater decreases from baseline in biochemical markers of bone turnover than did placebo (P < 0.001). CONCLUSION: Alendronate increased BMD at both the spine and hip in elderly female residents of long-term care facilities.