Long-Term Approaches to Treating Osteoporosis

治疗骨质疏松症的长期方法

基本信息

批准号：
10804038
负责人：
Smita Nayak
金额：
$ 22.3万
依托单位：
BERKELEY MADONNA, INC.
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-30 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10804038
关键词：
Acute Acute myocardial infarction Address Adherence Adverse event Affect Age Aging Alendronate American Anabolic Agents Area Bone Density Bone Diseases Calcium Caring Categories Cerebrovascular Disorders Characteristics Chronic Chronic Disease Clinical Clinical Research Clinical Trials Collaborations Combined Modality Therapy Cost Effectiveness Analysis Data Elderly Exercise Therapy Face Forteo Fracture Future Hip Fractures Holidays Ibandronate Individual Investigation Knowledge Medical Medicare Meta-Analysis Modeling Morbidity - disease rate Osteoporosis Outcome Outcome Measure Patients Pattern Persons Pharmaceutical Preparations Pharmacological Treatment Physicians Pneumonia Population Postmenopause Professional Organizations Publication Bias Raloxifene Recommendation Recording of previous events Regimen Reporting Research Review Literature Risedronate Risk Risk Reduction Sequential Treatment Spinal Fractures Subgroup Testing Therapeutic Therapeutic Agents Time Treatment Protocols United States United States National Institutes of Health Vitamin D Woman Work Zoledronic Acid arm beneficiary bisphosphonate bone bone loss bone strength clinical care clinical efficacy compare effectiveness cost cost effective cost effectiveness efficacy evaluation evidence base experience falls fracture risk fragility fracture human old age (65+)improved innovation interest men mortality novel observational cohort study osteoporosis with pathological fracture personalized management prevent relative cost relative effectiveness skeletal disorder systematic review treatment as usual treatment strategy

项目摘要

Project Summary/Abstract Osteoporosis, a skeletal disease characterized by compromised bone strength and increased risk of fracture, affects 10 million older adults in the United States. Approximately 50% of postmenopausal women and 25% of white men over age 60 will experience an osteoporotic fracture in their lifetimes, and the morbidity, mortality, and costs are high and projected to increase with the aging of the U.S. population. There are many effective pharmacological treatment options for osteoporosis, which broadly fall into categories of antiresorptive agents that inhibit bone breakdown and anabolic agents that build bone. However, individual osteoporosis therapies are not recommended for indefinite use, although osteoporosis is a chronic disease that requires long-term management to maintain reduced risk of fragility fracture. Thus, treatment of osteoporosis over the lifetime involves transitions between agents. Sequential use of osteoporosis medications is a novel and important area of investigation that requires further examination. Additionally, the use of combination treatment regimens with multiple medications is another important topic of interest that may be effective and appropriate short-term therapy for some individuals with osteoporosis at particularly high fracture risk. Currently, there is little scientific evidence to guide physicians and patients with osteoporosis on best strategies for transitions between medications for long-term treatment, and this has been identified as a key knowledge gap in the field by professional societies and the NIH. With the work proposed in this application we aim to address this knowledge gap by evaluating many different long-term treatment strategies for osteoporosis, including sequential and combination therapies, to identify the best therapeutic approaches over the lifetime. To do so, we propose to first perform meta-analyses of clinical studies on the efficacy of sequential and combination therapies for osteoporosis (Aim 1). Subsequently, we will perform comprehensive cost-effectiveness analyses comparing various long-term treatment strategies, including sequential and combination therapy regimens, as well as the use of single therapeutic agents with intermittent drug holidays, exercise therapy, and usual care (calcium and vitamin D only) for patients with osteoporosis and different clinical characteristics (Aim 2). Our research findings will elucidate which osteoporosis treatment strategies are most effective and cost-effective for individuals with various clinical characteristics over the lifetime, and thus directly address one of the biggest challenges facing physicians who treat patients with osteoporosis. This innovative investigation will help provide the framework for evidence- based and individualized management of transitions of therapy for millions of Americans with osteoporosis.

项目概要/摘要骨质疏松症是一种骨骼疾病，其特征是骨强度受损和骨折风险增加，影响美国 1000 万老年人。大约 50% 的绝经后妇女和 25% 60岁以上的白人男性一生中都会经历骨质疏松性骨折，发病率、死亡率、而且成本很高，并且预计随着美国人口的老龄化而增加。有很多有效的骨质疏松症的药物治疗选择，大致属于抗骨吸收剂类别抑制骨分解和合成代谢剂来构建骨骼。然而，个体骨质疏松症尽管骨质疏松症是一种慢性疾病，但不建议无限期使用治疗方法需要长期管理以降低脆性骨折的风险。因此，治疗一生中的骨质疏松症涉及药物之间的转换。骨质疏松症序贯使用药物治疗是一个新颖且重要的研究领域，需要进一步检查。此外，使用多种药物的联合治疗方案是另一个重要的话题，可能会引起人们的兴趣。对某些骨质疏松症患者的短期治疗效果特别好骨折风险。目前，几乎没有科学证据可以指导医生和患者骨质疏松症长期治疗药物转换的最佳策略，以及已被专业协会和 NIH 确定为该领域的关键知识差距。随着在本申请中提出的工作，我们的目标是通过评估许多不同的长期目标来解决这一知识差距骨质疏松症的治疗策略，包括序贯疗法和联合疗法，以确定最佳治疗方案终生的治疗方法。为此，我们建议首先对临床数据进行荟萃分析序贯疗法和联合疗法治疗骨质疏松症的疗效研究（目标 1）。随后，我们将进行全面的成本效益分析，比较各种长期治疗策略，包括序贯和联合治疗方案，以及使用单一治疗药物间歇性药物假期、运动疗法和常规护理（仅钙和维生素 D）骨质疏松症和不同的临床特征（目标 2）。我们的研究结果将阐明哪些对于患有各种临床症状的个体来说，骨质疏松症治疗策略是最有效且最具成本效益的一生中的特征，从而直接解决医生面临的最大挑战之一治疗骨质疏松症患者。这项创新调查将有助于提供证据框架为数百万患有骨质疏松症的美国人提供基于个性化的治疗过渡管理。