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In the United States, osteoporosis affects over 10 million adults, has high societal costs ( $22 billion in 2008), and is currently being underdiagnosed and undertreated. Given an aging population, this burden is expected to rise. We projected the fracture burden in US women by modeling the expected demographic shift as well as potential policy changes. With the anticipated population aging and growth, annual fractures are projected to increase from 1.9 million to 3.2 million (68%), from 2018 to 2040, with related costs rising from $ 57 billion to over$95 billion. Policy‐driven expansion of case finding and treatment of at‐risk women could lower this burden, preventing 6.1 million fractures over the next 22 years while reducing payer costs by $ 29 billion and societal costs by $55 billion. Increasing use of osteoporosis‐related interventions can reduce fractures and result in substantial cost‐savings, a rare and fortunate combination given the current landscape in healthcare policy. © 2019 The Authors. JBMR Plus published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.

ABSTRACT Background: Osteoporosis is a major and costly global public health problem. It is a chronic disease in which fracture is the main outcome, and the impact of these fractures can vary depending on the age of the individual and the severity of the fracture. Scope: Using literature review, this paper discusses and summarizes the information available regarding the individual and socio-economic consequences associated with the several types of osteoporotic fractures. Findings: Different types of osteoporotic fractures are generally associated with different age groups. The health-economic impact of vertebral and hip fractures has been extensively explored and it is well known that these fractures are associated with morbidity/disability and increased mortality; they also account for a substantial portion of the direct fracture costs. However, to accurately estimate the individual and socio-economic burden of the disease, further research is needed on the morbidity/disability, mortality, and costs associated with non-hip, nonvertebral fractures, which account for more than half of the total fractures. More data are also required on the indirect costs associated with all fracture types. Conclusions: Understanding the socio-economic consequences of each fracture type will be important to fully estimate the burden of osteoporosis and may help clinicians tailor management plans for individual patients.

Background Osteoporosis is often considered to be a disease of women. Over the last few years, owing to the increasing clinical and economic burden, the awareness and imperative for identifying and managing osteoporosis in men have increased substantially. With the approval of agents to treat men with osteoporosis, more economic evaluations have been conducted to assess the potential economic benefits of these interventions. Despite this concern, there is no specific overview of cost-effectiveness analyses for the treatment of osteoporosis in men. Objectives This study aims (1) to systematically review economic evaluations of interventions for osteoporosis in men; (2) to critically appraise the quality of included studies and the source of model input data; and (3) to investigate the comparability of results for studies including both men and women. Methods A literature search mainly using MEDLINE (via Ovid) and Embase databases was undertaken to identify original articles published between 1 January, 2000 and 30 June, 2022. Studies that assessed the cost effectiveness of interventions for osteoporosis in men were included. The Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases and the International Osteoporosis Foundation osteoporosis-specific guideline was used to assess the quality of design, conduct, and reporting of included studies. Results Of 2973 articles identified, 25 studies fulfilled the inclusion criteria, classified into economic evaluations of active drugs ( n = 8) or nutritional supplements ( n = 4), intervention thresholds ( n = 5), screening strategies ( n = 6), and post-fracture care programs ( n = 2). Most studies were conducted in European countries ( n = 15), followed by North America ( n = 9). Bisphosphonates (namely alendronate) and nutritional supplements were shown to be generally cost effective compared with no treatment in men over 60 years of age with osteoporosis or prior fractures. Two other studies suggested that denosumab was cost effective in men aged 75 years and older with osteoporosis compared with bisphosphates and teriparatide. Intervention thresholds at which bisphosphonates were found to be cost effective varied among studies with a 10-year probability of a major osteoporotic fracture that ranged from 8.9 to 34.2% for different age categories. A few studies suggested cost effectiveness of screening strategies and post-fracture care programs in men. Similar findings regarding the cost effectiveness of drugs and intervention thresholds in women and men were captured, with slightly greater incremental cost-effectiveness ratios in men. The quality of the studies included had an average score of 18.8 out of 25 (range 13–23.5). Hip fracture incidence and mortality risk were mainly derived from studies in men, while fracture cost, treatment efficacy, and disutility were commonly derived from studies in women or studies combining both sexes. Conclusions Anti-osteoporosis drugs and nutritional supplements are generally cost effective in men with osteoporosis. Screening strategies and post-fracture care programs also showed economic benefits for men. Cost-effectiveness and intervention thresholds were generally similar in studies conducted in both men and women, with slightly greater incremental cost-effectiveness ratios in men.

Background Osteoporotic-related fractures represent an increasing burden to patients, health care systems and society. Aims This study estimated cost-effectiveness of sequential treatment with abaloparatide (ABL) followed by alendronate (ALN) compared to relevant alternative strategies in US men and women aged 50 to 80 years at very high fracture risk (bone mineral density T-score ≤  − 2.5 and a recent fracture). Methods A lifetime Markov-based microsimulation model was used to estimate healthcare costs and quality-adjusted life years (QALYs). Comparators were sequential treatment with unbranded teriparatide (TPTD)/ALN, generic ALN monotherapy, and no treatment. Analyses were conducted based on initial fracture site (hip, vertebral, or any fracture) and treatment efficacy data (derived from clinical trials or a recent network meta-analysis). Results From all analyses completed, sequential ABL/ALN demonstrated more QALYs for lower healthcare costs versus unbranded TPTD/ALN. No treatment was dominated (higher costs for less QALYs) versus ALN monotherapy. Sequential ABL/ALN resulted in favorable cost-effectiveness (at US threshold of $150,000/QALY) versus generic ALN monotherapy in men aged ≥ 50 years with any fracture type, women aged ≥ 65 years with any fracture type, and women aged ≥ 55 years having a hip or vertebral fracture. Discussion Similar cost-effectiveness of sequential ABL/ALN versus unbranded TPTD/ALN, ALN monotherapy, and no treatment was observed in both US men and women at very high fracture risk, with a moderate improvement in cost-effectiveness in men versus women and in patients with a hip or vertebral fracture. Conclusions Sequential therapy with ABL/ALN was cost-effective in US men and women at very high risk of fractures.

Background and Objectives Abaloparatide (ABL) significantly increases bone mineral density in men with osteoporosis similar to what was reported in postmenopausal women with osteoporosis. The cost effectiveness of sequential treatment with ABL followed by alendronate (ALN) in men at high fracture risk was compared to relevant alternative treatments. Methods A Markov-based microsimulation model based on a lifetime US healthcare decision maker perspective was developed to evaluate the cost (expressed in US$2021) per quality-adjusted life-years (QALYs) gained of sequential ABL/ALN. Comparators were sequential treatment unbranded teriparatide (TPTD)/ALN, generic ALN monotherapy, and no treatment. Discount rates of 3% were used. Consistent with practice guidelines, patients received 18 months of ABL or TPTD followed by ALN for 5 years, or 5 years of ALN monotherapy. Analyses were conducted in high-risk men aged over 50 years defined as having a bone mineral density T-score ≤−2.5 and a recent fracture. Time-specific risk of subsequent fracture after a recent fracture, incremental costs up to 5 years following fractures, real-world medication adherence, and mostly US men-specific data were included in the model. One-way and probabilistic sensitivity analyses were conducted to assess the robustness of results. Results Over the full age range, sequential ABL/ALN led to more QALYs for lower costs than sequential unbranded TPTD/ALN, while no treatment was dominated (more QALYs, lower costs) by ALN monotherapy. The costs per QALY gained of sequential ABL/ALN were lower than the US threshold of US$150,000 versus generic ALN monotherapy. The probabilities that sequential ABL/ALN was cost effective compared to ALN monotherapy were estimated at 51% in men aged 50 years and between 88 and 90% in those aged ≥ 60 years. Conclusions Sequential therapy using ABL/ALN may be cost effective compared with generic ALN monotherapy in US men aged ≥ 50 years at high fracture risk, especially in those aged ≥ 60 years. Unbranded TPTD/ALN and no treatment were dominated interventions (less QALY, more costs) compared with ABL/ALN or ALN monotherapy.

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ABSTRACT Background: Osteoporosis is a prevalent disease with substantial individual and socioeconomic consequences. The challenges faced by physicians include identifying individuals at high risk of fracture, selecting the optimal treatment plan for each patient, and educating patients regarding their role in the effectiveness of therapy. Scope: This article discusses screening and patient selection for osteoporosis treatment, as well as available bisphosphonate therapies. Data on patient adherence and cost-effectiveness are also reviewed. The aim is to raise awareness among clinicians of the importance of osteoporosis assessment and of the differences in clinical outcomes between therapies. Findings: Reviewed data indicates that risk-factor assessment is invaluable in diagnosing osteoporosis and guidelines are available which should be consulted to help determine which patients need treatment. When selecting a treatment plan, the differences between therapies in terms of vertebral and nonvertebral efficacy, timing of onset of action, and tolerability should be considered. Furthermore, patient adherence to a particular therapy will affect its effectiveness and can be improved through active patient education. Finally, given the large number of affected individuals, cost-effectiveness of therapies should be considered. Conclusion: The appropriate therapy should match individual patient needs in terms of efficacy, early onset of action, tolerability, and likelihood of patient adherence to treatment.

Disclosure: M. Hiligsmann: Grant Recipient; Self; Radius Health, Inc. S. Silverman: Consulting Fee; Self; Amgen Inc, Radius Health, Inc. Grant Recipient; Self; Amgen Inc, Radius Health, Inc. A.J. Singer: Consulting Fee; Self; Agnovos, Amgen Inc, Radius Health, Inc, UCB. Speaker; Self; Amgen Inc, Radius Health, Inc. L. Pearman: Employee; Self; Radius Health, Inc. Stock Owner; Self; Radius Health, Inc. Y. Wang: Employee; Self; Radius Health, Inc. Stock Owner; Self; Radius Health, Inc. J.N. Caminis: Employee; Self; Radius Health, Inc. Stock Owner; Self; Radius Health, Inc. J. Reginster: Advisory Board Member; Self; Pierre Fabre. Consulting Fee; Self; IBSA-Genevrier, Mylan, Teva Pharmaceutical Industries Ltd. Speaker; Self; IBSA-Genevrier, Mylan, CNIEL, Dairy Research Council, Teva Pharmaceutical Industries Ltd. Background: Cost-effectiveness analyses are becoming increasingly important for efficiency in healthcare resource allocation. This study aims to assess the cost-effectiveness of four common treatment approaches of US men and women at very high risk of fracture: bisphosphonate (alendronate [ALN]) monotherapy, sequential treatment with an anabolic first (either abaloparatide [ABL] or teriparatide [TPTD]) followed by a bisphosphonate, and no treatment, as many patients at very high fracture risk do not receive an osteoporosis medication. Methods: A microsimulation-based Markov model was used to assess the cost-effectiveness of four treatment approaches in US women and men aged 50 to 80 years who had a recent fracture and had densitometry-confirmed osteoporosis (bone mineral density T-score ≤−2.5): ALN monotherapy, sequential ABL/ALN, sequential unbranded TPTD/ALN, and no treatment. Analyses were conducted from the US healthcare decision-maker perspective using$2022 costs, and health outcomes were expressed in quality-adjusted life years (QALYs). Deterministic and probabilistic sensitivity analyses were performed to characterize uncertainty. Results: In both sexes and over the full age range, no treatment and sequential unbranded TPTD/ALN were dominated (ie, they had lower QALYs for more costs than a comparator treatment), and should be excluded. Sequential ABL/ALN was associated with more QALYs and more costs than ALN monotherapy. At the US threshold of $ 150,000 per QALY gained, sequential ABL/ALN was cost-effective compared to ALN monotherapy in men aged ≥50 years and in women aged ≥65 years. Sensitivity analyses suggested that sequential ABL/ALN was also cost-effective in women with a recent hip or vertebral fracture aged ≥55 years. Conslusion: In both US men (aged ≥50 years) and women (aged ≥65 years) at very high risk of fracture, sequential ABL/ALN is the most cost-effective intervention among the four treatment approaches. Sequential unbranded TPTD/ALN and no treatment were dominated, and are thus not efficient treatment approaches. Treating US men and women at very high fracture risk with sequential ABL/ALN leads to an efficient resource allocation. Presentation: Friday, June 16, 2023

In the United States, more than 53 million individuals either have osteoporosis or low bone mass, placing them at increased risk for fracture. The current clinical and economic burden of osteoporosis is high due to the cost of osteoporotic fractures. This cost includes both direct medical costs, such as inpatient hospitalizations, care in skilled nursing facilities, outpatient office visits, and medications, as well as indirect societal costs related to productivity losses and informal caregiving. The burden of osteoporosis may be reduced through both the primary and secondary prevention of fractures. As the rate and costs of subsequent fracture after a new osteoporotic fracture are particularly high, preventing even a modest percentage of subsequent fractures may lead to substantial cost savings.

[Display omitted] Early detection of atrial fibrillation or flutter (AF) may enable prevention of downstream morbidity. Consumer wrist-worn wearable technology is capable of detecting AF by identifying irregular pulse waveforms using photoplethysmography (PPG). The validity of PPG-based software algorithms for AF detection requires prospective assessment. The Fitbit Heart Study (NCT04380415) is a single-arm remote clinical trial examining the validity of a novel PPG-based software algorithm for detecting AF. The proprietary Fitbit algorithm examines pulse waveform intervals during analyzable periods in which participants are sufficiently stationary. Fitbit consumers with compatible wrist-worn trackers or smartwatches were invited to participate. Enrollment began May 6, 2020 and as of October 1, 2020, 455,699 participants enrolled. Participants in whom an irregular heart rhythm was detected were invited to attend a telehealth visit and eligible participants were then mailed a one-week single lead electrocardiographic (ECG) patch monitor. The primary study objective is to assess the positive predictive value of an irregular heart rhythm detection for AF during the ECG patch monitor period. Additional objectives will examine the validity of irregular pulse tachograms during subsequent heart rhythm detections, self-reported AF diagnoses and treatments, and relations between irregular heart rhythm detections and AF episode duration and time spent in AF. The Fitbit Heart Study is a large-scale remote clinical trial comprising a unique software algorithm for detection of AF. The study results will provide critical insights into the use of consumer wearable technology for AF detection, and for characterizing the nature of AF episodes detected using consumer-based PPG technology.