Long-Term Approaches to Treating Osteoporosis

治疗骨质疏松症的长期方法

• 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
• 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

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.

项目摘要/摘要 骨质疏松症，一种以骨骼强度受损和骨折风险增加为特征的骨骼疾病， 在美国影响1000万老年人。绝经后妇女约有50％和25％ 60岁以上的白人一生将经历骨质疏松性骨折，以及发病率，死亡率， 成本很高，预计随着美国人口的衰老而增加。有很多有效 骨质疏松症的药理学治疗选择，该方法广泛地属于抗吸收剂类别 抑制骨骼崩溃和造成骨骼的合成代谢剂。但是，个体骨质疏松症 不建议无限期使用疗法，尽管骨质疏松症是一种慢性疾病 需要长期管理以维持脆弱性骨折的风险降低。因此，处理 一生中骨质疏松症涉及药物之间的过渡。顺序使用骨质疏松症 药物是一个新颖而重要的调查领域，需要进一步检查。另外， 使用多种药物的组合治疗方案是另一个重要的主题 对于某些骨质疏松症的人特别高的人有效且适当的短期治疗 断裂风险。目前，几乎没有科学证据来指导医生和患者 骨质疏松症是针对长期治疗药物之间过渡的最佳策略，这 专业社会和NIH已将其视为该领域的关键知识差距。与 在本应用程序中提出的工作我们旨在通过评估许多不同的长期来解决这一知识差距 骨质疏松症的治疗策略，包括顺序和联合疗法，以识别最佳 一生中的治疗方法。为此，我们建议先执行临床的荟萃分析 关于顺序和联合疗法对骨质疏松症的疗效的研究（AIM 1）。随后，我们会的 进行全面的成本效益分析，比较各种长期治疗策略， 包括顺序和联合治疗方案，以及使用单个治疗剂 与患者 骨质疏松症和不同的临床特征（AIM 2）。我们的研究发现将阐明哪个 骨质疏松治疗策略对具有各种临床的人最有效，最具成本效益 一生中的特征，因此直接解决了医生面临的最大挑战之一 治疗骨质疏松症患者。这项创新的调查将有助于为证据提供框架 - 基于骨质疏松症的数百万美国人的基于和个性化的治疗过渡管理。