Background: Osteoporotic fractures are common among postmenopausal women and are associated with morbidity, mortality, and impaired quality of life. Despite the elevated risk of subsequent fractures, post-fracture treatment initiation remains low. This study evaluated subsequent fracture risk and treatment uptake among postmenopausal women in the US.Methods: We conducted a retrospective cohort study using Optum© Clinformatics® Data Mart administrative claims database to identify U.S. women aged ≥50 years with an incident clinical fracture between 2012 and 2021. Primary outcomes included subsequent fracture at any site, hip/femur, and spine occurring ≥90 days after the index fracture. The secondary outcome was initiation of prescription osteoporosis treatment. Cumulative incidence at 6, 12, and 24 months was estimated using an inverse probability weighted estimator, with stratification by index fracture site, prior osteoporosis diagnosis, and age.Results: A total of 467,721 women with an incident fracture were identified; median age at index fracture was 76 years. The 24-month cumulative risk of any subsequent fracture was 19.4% overall, with the highest risk observed in women with an index spine (27.8%) and pelvic fracture (24.2%). Subsequent fracture risk was higher in women with a prior osteoporosis diagnosis and increased with age. Treatment initiation by 24 months was 17.5% with 64% of treatments occuring within the first six months. Oral bisphosphonates were the most commonly initiated therapy.Conclusions: In this large national cohort, subsequent fracture risk was high, yet treatment initiation remained low. These results underscore the need for timely osteoporosis therapy to reduce secondary fracture risk.
This survey of 116 patients aged ≥ 50 years with ≥ 1 confirmed symptomatic vertebral fracture within 36 weeks prior to enrollment showed that pain related to fracture persisted after 24 weeks for a subset of patients and affected activities of daily living. These data emphasize the importance of vertebral fracture prevention. To describe pain persistence, severity, and effect on ADLs after symptomatic vertebral fracture. This was an observational cross-sectional survey of patients recruited from 7 United States clinical sites aged ≥ 50 years with ≥ 1 symptomatic osteoporotic vertebral fracture diagnosed within the prior 36 weeks. Patients’ experience of pain and its impact on ADLs during the past 7 days before the patient survey were evaluated. Data were collected through one-time patient surveys and retrospective medical chart review and analyzed descriptively. Of 116 patients enrolled, most were postmenopausal women (83
Although clinical trials have shown that denosumab significantly increases bone mineral density at key skeletal sites more than oral bisphosphonates, evidence is lacking from head-to-head randomized trials evaluating fracture outcomes. This retrospective cohort study uses administrative claims data from Medicare fee-for service beneficiaries to evaluate the comparative effectiveness of denosumab vs alendronate in reducing fracture risk among women with PMO in the US. Women with PMO ≥ 66 yr of age with no prior history of osteoporosis treatment, who initiated denosumab (n = 89 115) or alendronate (n = 389 536) from 2012 to 2018, were followed from treatment initiation until the first of a specific fracture outcome, treatment discontinuation or switch, end of study (December 31, 2019), or other censoring criteria. A doubly robust inverse-probability of treatment and censoring weighted function was used to estimate the risk ratio associated with the use of denosumab compared with alendronate for hip, nonvertebral (NV; includes hip, humerus, pelvis, radius/ulna, other femur), non-hip nonvertebral (NHNV), hospitalized vertebral (HV), and major osteoporotic (MOP; consisting of NV and HV) fractures. Overall, denosumab reduced the risk of MOP by 39%, hip by 36%, NV by 43%, NHNV by 50%, and HV fractures by 30% compared with alendronate. Denosumab reduced the risk of MOP fractures by 9% at year 1, 12% at year 2, 18% at year 3, and 31% at year 5. An increase in the magnitude of fracture risk reduction with increasing duration of exposure was also observed for other NV fracture outcomes. In this cohort of almost half-a-million treatment-naive women with PMO, we observed clinically significant reductions in the risk of MOP, hip, NV, NHNV, and HV fractures for patients on denosumab compared with alendronate. Patients who remained on denosumab for longer periods of time experienced greater reductions in fracture risk.
Summary In a characterization of treatment rates and healthcare costs among patients with an osteoporotic-related fragility fracture overall and by site of care, costs were high and treatment rates were low. Purpose Osteoporotic fractures can be debilitating, even fatal, among older adults. The cost of osteoporosis and related fractures is projected to increase to more than $25 billion by 2025. The objective of this analysis is to characterize disease-related treatment rates and healthcare costs of patients with an osteoporotic fragility fracture overall and by site of fracture diagnosis. Methods In this retrospective analysis, individuals with fragility fractures were identified in the Merative MarketScan® Commercial and Medicare Databases among women 50 years of age or older and diagnosed with fragility fracture between 1/1/2013 and 6/30/2018 (earliest fracture diagnosis = index). Cohorts were categorized by clinical site of care where the diagnosis of fragility fracture was made and were continuously followed for 12 months prior to and following index. Sites of care were inpatient admission, outpatient office, outpatient hospital, emergency room hospital, and urgent care. Results Of the 108,965 eligible patients with fragility fracture (mean age 68.8), most were diagnosed during an inpatient admission or outpatient office visit (42.7%, 31.9%). The mean annual healthcare costs among patients with fragility fracture were $44,311 (± $67,427) and were highest for those diagnosed in an inpatient setting ($71,561 ± $84,072). Compared with other sites of care at fracture diagnosis, patients diagnosed during an inpatient admission also had highest proportion of subsequent fractures (33.2%), osteoporosis diagnosis (27.7%), and osteoporosis therapy (17.2%) during follow-up. Conclusion The site of care for diagnosis of fragility fracture affects treatment rates and healthcare costs. Further studies are needed to determine how attitude or knowledge about osteoporosis treatment or healthcare experiences differ at various clinical sites of care in the medical management of osteoporosis.
In postmenopausal women with osteoporosis, up to 10 years of denosumab treatment significantly and continuously improved bone microarchitecture assessed by tissue thickness–adjusted trabecular bone score, independently of bone mineral density. Long-term denosumab treatment decreased the number of high fracture-risk patients and shifted more patients to lower fracture-risk categories. To investigate the long-term effect of denosumab on bone microarchitecture assessed by tissue thickness–adjusted trabecular bone score (TBSTT) in post-hoc subgroup analysis of FREEDOM and open-label extension (OLE). Postmenopausal women with lumbar spine (LS) or total hip BMD T-score <−2.5 and ≥−4.0 who completed the FREEDOM DXA substudy and continued in OLE were included. Patients received either denosumab 60 mg subcutaneously every 6 months for 3 years and same-dose open-label denosumab for 7 years (long-term denosumab; n=150) or placebo for 3 years and open-label denosumab for 7 years (crossover denosumab; n=129). BMD and TBSTT were assessed on LS DXA scans at FREEDOM baseline, month 1, and years 1–6, 8, and 10. In long-term denosumab group, continued increases from baseline to years 4, 5, 6, 8, and 10 in BMD (11.6%, 13.7%, 15.5%, 18.5%, and 22.4%) and TBSTT (3.2%, 2.9%, 4.1%, 3.6%, and 4.7%) were observed (all P < 0.0001). Long-term denosumab treatment decreased the proportion of patients at high fracture-risk (according to TBSTT and BMD T-score) from baseline up to year 10 (93.7 to 40.4%), resulting in increases in the proportions at medium-risk (6.3 to 53.9%) and low-risk (0 to 5.7%) (P < 0.0001). Similar responses were observed in crossover denosumab group. Changes in BMD and TBSTT were poorly correlated during denosumab treatment. In postmenopausal women with osteoporosis, up to 10 years of denosumab significantly and continuously improved bone microarchitecture assessed by TBSTT, independently of BMD, and shifted more patients to lower fracture-risk categories.
Objective: Describe patient characteristics, health care resource utilization, costs, and humanistic burden of women with Medicare insurance with incident fragility fracture who were admitted to post-acute-care (PAC). Design: Retrospective cohort study using 100% Medicare Fee-for-Service (FFS) data. Setting and Participants: Community-dwelling female Medicare beneficiaries with incident fragility fracture January 1, 2017, to October 17, 2019, resulting in PAC admission to a skilled nursing facility (SNF), home-health care, inpatient-rehabilitation facility, or long-term acute-care hospital. Methods: Patient demographic/clinical characteristics were measured during 1-year baseline. Resource utilization and costs were measured during baseline, PAC event, and PAC follow-up. Humanistic burden was measured among SNF patients with linked Minimum Data Set assessments. Multivariable regression examined predictors of PAC costs after discharge and changes in functional status during SNF stay. Results: A total of 388,732 patients were included. Compared with baseline, hospitalization rates were 3.5, 2.4, 2.6, and 3.1 times higher and total costs 2.7, 2.0, 2.5, and 3.6 times higher for SNF, home-health, inpatient-rehabilitation, and long-term acute-care, respectively, following PAC discharge. Utilization of dual-energy X-ray absorptiometry (DXA) and osteoporosis medications remained low: 8.5% to 13.7% received DXA during baseline vs 5.2% to 15.6% following PAC; 10.2% to 12.0% received osteoporosis medication during baseline vs 11.4% to 22.3% following PAC. Dual eligibility for Medicaid (ie, low income) was associated with 12% higher costs; Black patients had 14% higher costs. Activities of daily living scores improved 3.5 points during SNF stay, but Black patients had 1.22-point lower improvement than White patients. Pain intensity scores showed small improvement (-0.8 points). Conclusions and Implications: Women admitted to PAC with incident fracture had high humanistic burden with little improvement in pain and functional status and significantly higher economic burden after discharge compared with baseline. Disparities in outcomes related to social risk factors were observed, with consistently low utilization of DXA and osteoporosis medications even after fracture. Results indicate a need for improved early diagnosis and aggressive disease management to prevent and treat fragility fractures. (c) 2023 The Authors. Published by Elsevier Inc. on behalf of AMDA - The Society for Post-Acute and Long-Term Care Medicine. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).
TBS algorithm has been updated to account for regional soft tissue noise. In postmenopausal women with osteoporosis, denosumab improved tissue thickness–adjusted TBS vs placebo independently of bone mineral density over 3 years, with the magnitude of changes from baseline or placebo numerically greater than body mass index–adjusted TBS. To evaluate the effect of denosumab on bone microarchitecture assessed by trabecular bone score (TBS) in the FREEDOM study using the updated algorithm that accounts for regional soft tissue thickness (TBSTT) in dual-energy X-ray absorptiometry (DXA) images and to compare percent changes from baseline and placebo with classical body mass index (BMI)–adjusted TBS (TBSBMI). Postmenopausal women with lumbar spine or total hip bone mineral density (BMD) T score < − 2.5 and ≥ − 4.0 received placebo or denosumab 60 mg subcutaneously every 6 months. TBSBMI and TBSTT were assessed on lumbar spine DXA scans at baseline and months 1, 12, 24, and 36 in a subset of 279 women (129 placebo, 150 denosumab) who completed the 3-year FREEDOM DXA substudy and rolled over to open-label extension study. Baseline characteristics were similar between groups. TBSTT in the denosumab group showed numerically greater changes from both baseline and placebo than TBSBMI at months 12, 24, and 36. Denosumab led to progressive increases in BMD (1.2, 5.6, 8.1, and 10.5%) and TBSTT (0.4, 2.3, 2.6, and 3.3%) from baseline to months 1, 12, 24, and 36, respectively. Both TBS changes were significant vs baseline and placebo from months 12 to 36 (p < 0.0001). As expected, BMD and TBSTT were poorly correlated both at baseline and for changes during treatment. In postmenopausal women with osteoporosis, denosumab significantly improved bone microstructure assessed by TBSTT over 3 years. TBSTT seemed more responsive to denosumab treatment than TBSBMI and was independent of BMD.