Long-Term Approaches to Treating Osteoporosis

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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.