Calculator for Length of Use of Bisphosphonates (CLUB)

双膦酸盐使用期限计算器 (CLUB)

• 批准号: 10515879
• 负责人: LAURA D CARBONE
• 金额: $ 125.14万
• 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/10515879
• 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; base; bisphosphonate; burden of illness; cohort; community living; comorbidity; cost effective; cost effectiveness; design; ethnic difference; fracture risk; high risk; medication safety; men; 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卫生问题，尤其是对老年人而言。 双膦酸盐（BPs）是一种廉价的治疗类药物，可有效预防 这些骨折。然而，在2009年， 至少部分是因为担心罕见的，尽管可能严重的副作用，即非典型的 股骨骨折（AFF）和双膦酸盐药物相关的颌骨骨坏死 （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。协助做出关于使用期限的决策 FDA和专业协会制定了指导方针，建议在三到 使用口服BP五年或静脉BP三年， 可能会有一个药物假期。然而，这些建议是基于 非常有限的证据主要来自白色、健康、社区居住的绝经后妇女 妇女此外，与药物假期相关的风险是不确定的，因为新出现的报告 表明许多妇女在停止治疗时发生了持续性骨折。是 最重要的是更好地了解长期BP治疗和药物治疗的风险-获益特征， 假期，在男性和女性，所有种族和民族，以及那些严重的 合并症。为了实现这一目标，我们组建了一个多学科专家团队， 从社区住宅到长期护理的大量不同患者人群 来自Kaiser Permanente（KP;北方加州、格鲁吉亚和大西洋中部地区）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）， 跨越30年（1996年至2025年），包括超过50万美国老年人， 开始用BP治疗骨质疏松症利用这些人口，我们将确定风险， 不间断地继续使用BP的益处、医疗保健成本和成本效益， 英国石油公司毒品假期。这些信息将用于开发风险因素计算器， 确定是否应休药期（双膦酸盐使用时间计算器 （CLUB））。一个专家小组，包括临床医生和消费者的声音将告知最终的 俱乐部的设计我们预计，CLUB将是一个临床上有用的即时护理工具， 共享BP使用的决策，并优化对有骨折风险的老年患者的护理。