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卫生问题，尤其是对于老年人。 双膦酸盐（BPS）是有效预防的廉价治疗类药物 这些断裂。但是，BPS用于骨质疏松症的使用已大幅下降 至少部分是由于对罕见的，尽管可能是严重的副作用，即非典型的副作用 股骨骨折（AFF）和双膦酸盐药物相关的颌骨 （mronj）。治疗持续时间是BPS长期副作用的危险因素，包括 AFF，较小程度的Mronj。协助有关使用时间的决策 FDA和专业社会制定了BPS 五年口服或三年的静脉注射使用，重新评估骨折风险 可能会提供毒品假期。但是，这些建议是基于 非常有限的证据主要来自白人，健康，社区居住的绝经后 女性。此外，正如新兴报道的那样，与毒品假期相关的风险是不确定的 表明许多女性在接受治疗时持续骨质疏松骨折。这是 至关重要的是更好地了解长期BP疗法和药物的风险效果 在男人和女人中，假期，所有种族和种族，以及认真的人 合并症。为此，我们积累了一个专业的多学科团队来学习 从社区居住到长期护理的大型患者人群 来自Kaiser Permanente（KP；北加州，佐治亚州和中大西洋地区）的居民， 卫生合作伙伴（HP；明尼苏达州）和国家退伍军人卫生管理局（VHA）， 跨越30年（1996年至2025年），其中包括超过半百万的美国成年人 开始用BP治疗骨质疏松症。利用该人群，我们将确定风险和 BPS与不间断延续的收益，医疗保健成本和成本效益 BP药物假期。这些信息将用于开发一个风险因素计算器 确定是否应该完成毒品假期（用于双膦酸盐使用时间的计算器 （俱乐部））。包括临床医生和消费者声音在内的专家小组将告知最终 俱乐部设计。我们预计俱乐部将成为指导临床上有用的护理工具 关于BP使用的共同决策，并为有骨折风险的老年患者提供护理。