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.

项目摘要/摘要在美国的老年人中，骨质疏松症非常普遍，大约1000万人做作的。近50％以上50岁的妇女和60岁以上的白人男性将遭受骨质疏松性骨折一生，带来重大后果，包括死亡，难以执行日常生活的活动，卧床能力的丧失，护士住房安置和慢性疼痛。双膦酸盐是破骨细胞骨重塑的强抑制剂的一类药物，是有效的用于减少骨折风险和最常见的骨质疏松治疗药物。 fda- 批准的双膦酸盐用于治疗骨质疏松症唑来膦酸。由于罕见严重的风险增加，不应无限期继续这些药物不良事件，例如非典型股骨骨折或颌骨的骨坏死，治疗持续时间超过5 年。但是，关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，对于停止治疗的个人，“药物的最佳持续时间假期”或在重新启动治疗之前停止治疗的时间段是未知的。双膦酸盐与骨头结合，可以保持多年的结合，因此导致残留停产后多年的药理活性。但是，在骨头多样性的结合双膦酸盐，因此，最佳药物度假持续时间可能会因特定的双膦酸盐。这项拟议的研究的目的是系统地回顾有关的证据每种FDA- 批准的双膦酸盐用于骨质疏松治疗以及相关的骨折风险降低效率和骨矿物质密度（BMD）对双膦酸盐处理的变化，药物节日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（不良事件率）（AIM 1）；并比较不同治疗和毒品度假持续时间的有效性和成本效益每种双膦酸盐用于骨质疏松症的美国成年人（AIM 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，并提供证据以指导治疗时间和毒品假期持续时间临床实践中的决定；并有助于实现未来的R01建议，以调查翻译的方法关于临床环境的最佳治疗方法的结果，以减少与骨质疏松相关的发病率和死亡。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，系统评价/荟萃分析和成本效益建模方面的专业知识以及轨道成功合作的记录。