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Osteoporosis Treatment and Drug Holiday Duration

骨质疏松症治疗和药物假期持续时间

基本信息

批准号：
9569267
负责人：
Smita Nayak
金额：
$ 15.96万
依托单位：
BERKELEY MADONNA, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-21 至 2020-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9569267
关键词：
Activities of Daily Living Acute Address Adult Adverse event Affect Affinity Aftercare Age Aging Alendronate American Binding Bone Density Bone necrosis Bone remodeling Cerebrovascular Disorders Cessation of life Clinical Collaborations Computer Simulation Elderly Expert Opinion FDA approved Femoral Fractures Fracture Future Hip Fractures Hip region structure Holidays Ibandronate Individual Intravenous Jaw Knowledge Length Literature Medical Medicare Meta-Analysis Modeling Morbidity - disease rate Myocardial Infarction Nursing Homes Oral Osteoclasts Osteoporosis Patients Pharmaceutical Preparations Pharmacology Placebos Pneumonia Population Recommendation Recording of previous events Relative Risks Research Residual state Risedronate Risk Risk Reduction Safety Serious Adverse Event Spinal Fractures Suggestion Time Translating Uncertainty United States Woman Work Zoledronic Acid base bisphosphonate bone chronic pain clinical care clinical practice comparative effectiveness compare effectiveness cost cost effective cost effectiveness effective therapy evidence base experience fracture risk high risk human old age (65+)inhibitor/antagonist men models and simulation mortality osteoporosis with pathological fracture spine bone structure systematic review therapy duration treatment duration

项目摘要

Project Summary/Abstract Osteoporosis is highly prevalent among older adults in the United States, with approximately 10 million people affected. Nearly 50% of women over age 50 years and 25% of white men over age 60 years will suffer an osteoporotic fracture in their lifetimes, with significant consequences including death, difficulty in performing activities of daily living, loss of ambulatory ability, nursing home placement, and chronic pain. Bisphosphonates, a class of medications that are strong inhibitors of osteoclast bone remodeling, are effective for reducing fracture risk and the most commonly prescribed medications for osteoporosis treatment. FDA- approved bisphosphonates for treatment of osteoporosis include alendronate, risedronate, ibandronate, and zoledronic acid. These medications should not be continued indefinitely due to an increased risk of rare serious adverse events, such as atypical femoral fracture or osteonecrosis of the jaw, with therapy duration beyond 5 years. However, there is uncertainty with respect to the optimal duration of bisphosphonate therapy for individuals with osteoporosis. Furthermore, for individuals who stop treatment, the optimal duration of the “drug holiday”, or period of time in which treatment is stopped before restarting treatment, is unknown. Bisphosphonates bind to bone and can remain bound for many years, thus resulting in residual pharmacological activity for years after discontinuation. However, binding affinity to bone varies among the bisphosphonates, and thus it is likely that the optimal drug holiday duration may vary depending on the particular bisphosphonate. The purpose of this proposed research is to systematically review the evidence on the duration of treatment for which fracture risk reduction has been demonstrated for each of the FDA- approved bisphosphonates for osteoporosis treatment and associated fracture risk reduction efficacy and change in bone mineral density (BMD) on bisphosphonate treatment, the impact of drugs holidays on fracture risk and BMD, and the safety (adverse events rates) associated with different durations of treatment (Aim 1); and to compare the effectiveness and cost-effectiveness of different treatment and drug holiday durations for each bisphosphonate for U.S. adults with osteoporosis (Aim 2). Our analyses would address key osteoporosis clinical care knowledge gaps and provide evidence to guide treatment duration and drug holiday duration decisions in clinical practice; and help enable a future R01 proposal to investigate approaches to translate findings about best treatment practices to the clinical setting to reduce osteoporosis-related morbidity and mortality. Our research team is ideally suited to perform this work; we have substantial experience and expertise in osteoporosis, systematic reviews/meta-analysis, and cost-effectiveness modeling, and a track record of successful collaboration.

项目总结/摘要骨质疏松症在美国的老年人中非常普遍，大约有1000万人影响。近50%的50岁以上的女性和25%的60岁以上的白色男性将遭受在他们的一生中，有重大后果，包括死亡，执行困难，日常生活活动、行走能力丧失、疗养院安置和慢性疼痛。双磷酸盐是一类有效的破骨细胞骨重建强效抑制剂用于降低骨折风险和治疗骨质疏松症的最常用处方药。FDA- 批准用于治疗骨质疏松症的双膦酸盐包括阿仑膦酸盐、利塞膦酸盐、伊班膦酸盐和唑来膦酸这些药物不应无限期地持续使用，因为罕见的严重治疗持续时间超过5年的不良事件，如非典型股骨骨折或颌骨骨坏死年然而，对于双膦酸盐治疗的最佳持续时间存在不确定性，患有骨质疏松症的人。此外，对于停止治疗的个体，“药物”的最佳持续时间假期”或重新开始治疗前停止治疗的时间段未知。二膦酸盐与骨结合，并可保持结合多年，从而导致残留停药后数年的药理活性。然而，与骨的结合亲和力在不同的细胞中是不同的。因此，最佳药物假期持续时间可能取决于药物组合而变化。特别是二膦酸盐。这项研究的目的是系统地审查证据，已证明FDA- 批准用于骨质疏松症治疗和相关骨折风险降低疗效的双膦酸盐，双膦酸盐治疗后骨密度（BMD）的变化，药物假期对骨折的影响风险和BMD，以及与不同治疗持续时间相关的安全性（不良事件发生率）（目标1）; 并比较不同治疗和药物假期持续时间的有效性和成本效益，每种双膦酸盐用于美国成年骨质疏松症患者（目标2）。我们的分析将解决关键的骨质疏松症临床护理知识差距，并提供证据来指导治疗持续时间和药物假期持续时间临床实践中的决策;并帮助实现未来的R 01提案，以研究将关于临床环境中减少糖尿病相关发病率的最佳治疗实践的研究结果， mortality.我们的研究团队非常适合执行这项工作;我们有丰富的经验，骨质疏松症的专业知识，系统综述/荟萃分析，成本效益建模，以及跟踪成功合作的记录。