This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Approximately 1.6 million hip fractures occur worldwide each year, with almost 350,000 occurring in the United States alone. Due to the graying of the US population, the number of hip fractures is expected to rise to more than 700,000 by the year 2050. Although most of the hip fractures are expected to occur in elderly women, at least 30% of the total number of fractured hips will occur in men. The cost of hip fractures is also on the rise, with more than $12.5 billion currently being spent each year, and an expected three-fold rise in health care costs for osteoporosis-related fractures projected over the next 40 years. For the people who survive a hip fracture, the change in quality of life is considerable. At one year post fracture, more than 50% of patients do not return to pre-fracture functional levels. Men and women who have had an osteoporotic hip fracture are at high risk for subsequent fractures, leading to further deterioration in quality of life. Anti-resorptive therapies with bisphosphonates, calcitonins, HRT, or raloxifene have been used to reduce the risk of osteoporotic vertebral, hip, and other non-vertebral fractures; maintain or improve bone mass; and to suppress excessive bone turnover. Clinical studies suggest that among anti-resorptive approaches, bisphosphonate therapy provides the most rapid and effective therapy for osteoporotic patients at high risk of fracture, although no head-to-head fracture trials have been conducted. The low bioavailability of oral bisphosphonates and their characteristic chemical toxicity to epithelial tissue makes the bisphosphonate class poorly tolerated and difficult to administer reliably by the oral route. Pamidronate has been used successfully by some practitioners off-label as an IV treatment for osteoporosis, but dose administration requires a prolonged IV infusion every three months, anti-fracture efficacy remains untested, and the treatment of osteoporosis indications unapproved. The sponsor believes that annual IV dosing with zoledronic acid, combined with standard calcium and Vitamin D supplementation, will be superior to oral administration of bisphosphonates or IV administration of pamidronate, and will lead to a successful test of anti-fracture efficacy of zoledronic acid.
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