Calculator for Length of Use of Bisphosphonates (CLUB)

双膦酸盐使用期限计算器 (CLUB)

• 批准号: 10700142
• 负责人: LAURA D CARBONE
• 金额: $ 114.58万
• 依托单位: AUGUSTA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10700142
• 关键词: Address; Adult; Area; Benefits and Risks; Bone necrosis; Calibration; California; Caring; Clinical; Clinical Trials; Communities; Data; Decision Making; Discrimination; Drug usage; Dual-Energy X-Ray Absorptiometry; Educational workshop; Elderly; Ensure; Ethnic Origin; Excess Mortality; Femoral Fractures; Fracture; Guidelines; Health; Health Benefit; Health Care Costs; Health care facility; Healthcare Systems; Holidays; Individual; Internet; Intravenous; Jaw; Length; Long-Term Care; Measures; Mid-Atlantic Region; Minnesota; Modeling; Morbidity - disease rate; Nursing Homes; Online Systems; Oral; Osteoporosis; Outcome; Pathway interactions; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Population; Population Heterogeneity; Postmenopause; Prevention; Prevention therapy; Professional Organizations; Public Health; Quality of life; Race; Recommendation; Recording of previous events; Reporting; Risk; Risk Estimate; Risk Factors; Safety; Sex Differences; Site; Therapeutic; Time; United States National Institutes of Health; Validation; Veterans Health Administration; Voice; Woman; administrative database; alternative treatment; bisphosphonate; burden of illness; cohort; community living; comorbidity; cost; cost effective; cost effectiveness; design; ethnic difference; falls; fracture risk; high risk; medication safety; men; models and simulation; mortality; multidisciplinary; older patient; osteoporosis with pathological fracture; patient population; point of care; population based; prediction algorithm; prevent; racial difference; risk/benefit ratio; sex; shared decision making; side effect; tool; treatment duration

Osteoporotic fractures are a major public health problem, especially for older persons. Bisphosphonates (BPs) are an inexpensive therapeutic class of drugs effective at preventing these fractures. However, there has been a substantial decline in use of BPs for osteoporosis at least in part because of concerns for rare, albeit potentially serious side effects, namely atypical femoral fractures (AFF) and bisphosphonate medication related osteonecrosis of the jaw (MRONJ). Duration of treatment is a risk factor for long-term side effects from BPs, including AFF, and to a lesser extent, MRONJ. To assist with decision-making regarding duration of use of BPs, the FDA and professional societies developed guidelines suggesting that after three to five years of oral or three years of intravenous BP use, that reassessment of fracture risk with possible provision of a drug holiday be done. However, these recommendations were based on very limited evidence largely derived from white, healthy, community-dwelling postmenopausal women. Moreover, the risk associated with drug holidays is uncertain, as emerging reports suggest that a number of women have sustained osteoporotic fractures while off therapy. It is paramount to better understand the risk-benefit profile of long-term BP therapy and drug holidays, in both men and women, all races and ethnicities, and those with serious comorbidities. To accomplish this, we have amassed an expert multidisciplinary team to study large and diverse patient populations ranging from community dwelling to long-term care residents from Kaiser Permanente (KP; Northern California, Georgia, and Mid-Atlantic regions), Health Partners (HP; Minnesota), and the national Veterans Health Administration (VHA), spanning 30 years (1996 to 2025) and including over half a million older U.S. adults who initiated osteoporosis treatment with a BP. Utilizing this population, we will determine risks and benefits, health care costs and cost effectiveness of uninterrupted continuation of BPs versus BP drug holidays. These information will be utilized to develop a risk factor calculator to determine if a drug holiday should be done (Calculator for Length of use of Bisphosphonates (CLUB)). An expert panel including both clinician and consumer voices will inform the final design of CLUB. We anticipate that CLUB will be a clinically useful point-of-care tool to guide shared decision-making on BP use and optimize care for older patients at risk for fracture.

骨质疏松性骨折是一个主要的公共健康问题，特别是对老年人来说。 双膦酸盐(BP)是一种廉价的治疗药物，有效地预防 这些骨折。然而，BP在治疗骨质疏松症方面的使用率大幅下降 部分原因是担心罕见的、尽管可能严重的副作用，即非典型副作用 股骨骨折(AFF)和双膦酸类药物治疗相关的颌骨骨坏死 (MRONJ)。治疗持续时间是BP长期副作用的风险因素，包括 AFF，在较小程度上，MRONJ。协助制定有关使用期限的决策 FDA和专业协会制定了指南，建议在三到三年后 口服或静脉注射BP五年或三年后，重新评估骨折风险 可能会提供一个禁毒日。然而，这些建议是基于 非常有限的证据主要来自绝经后白人健康的社区居住 女人。此外，正如新出现的报告所述，与毒品假期相关的风险是不确定的 表明许多女性在停止治疗期间持续发生骨质疏松性骨折。它是 最重要的是更好地了解长期BP治疗和药物的风险-收益概况 节日，无论男女，所有种族和民族，以及那些严重的 合并症。为此，我们组建了一支多学科的专家团队进行研究。 从社区居住到长期护理，患者群体庞大而多样 来自Kaiser Permanente(KP；北加州、佐治亚州和大西洋中部地区)的居民， 健康伙伴(惠普；明尼苏达州)和国家退伍军人健康管理局(VHA)， 跨度为30年(1996年至2025年)，其中包括超过50万的美国老年人 开始治疗骨质疏松症，血压升高。利用这些人群，我们将确定风险和 不间断持续BPS的好处、医疗成本和成本效益与 英国石油公司的药品假日。这些信息将被用来开发风险因素计算器，以 确定是否应该放假(双膦酸类药物使用时间的计算器 (俱乐部))。一个包括临床医生和消费者声音的专家小组将向决赛通报 球杆的设计。我们预计，该俱乐部将成为临床上有用的指导护理点的工具 共享BP使用决策，并优化对有骨折风险的老年患者的护理。