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Calculator for Length of Use of Bisphosphonates (CLUB)

双膦酸盐使用期限计算器 (CLUB)

基本信息

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
项目类别：
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

项目摘要

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重大的公共卫生问题，尤其是对老年人而言。