(Taken from the application): Osteoporosis is a major cause of morbidity and mortality in the United States. It is a disease of aging and its prevalence increases with each decade of life. In the typical nursing home, well over half of the residents will have remarkably diminished bone density and most of these individuals are susceptible to fractures. Optimal therapy has not been established. The current proposal is a clinical trial planning grant. Fourteen medical school affiliated nursing homes have organized into a research cooperative (The National Geriatrics Research Consortium [NGRC]) for the purpose of strengthening clinical research in the nursing home. This consortium plans to investigate a newly developed pharmacologic agent, zoledronate, for the treatment of osteoporosis in nursing home patients. In a one year planning phase, issues of research methodology and clinical trial design will be examined and a coordinated research proposal will be submitted upon completion of this planning phase. Several features about nursing home research make such a planning period advantageous. These include the likelihood of coexisting medical conditions in the patient volunteers and the frequent use of multiple other prescription medications. Furthermore, issues of informed consent from patients with cognitive impairment (as is the case with many, if not most of the potential subjects in our proposed trial), need to be fully understood. Details of the proposed trial are under development but it is the current expectation that it will be a multi institutional (NGRC), masked, randomized, placebo controlled clinical study in which nursing home patients with osteoporosis will receive either zoledronate or placebo every two months for two years. The primary outcome to be measured will be the occurrence of fractures and secondary outcomes will be pain relief, quality of life and bone mineral density. The outcome of this planning grant will be well constructed research proposal describing in detail this proposed clinical research.
|Dardzinski, B J; Schmithorst, V J; Holland, S K et al. (2001) MR imaging of murine arthritis using ultrasmall superparamagnetic iron oxide particles. Magn Reson Imaging 19:1209-16|