As stated by a recent consensus conference sponsored by the National Institute of Arthritis and Musculoskeletal, Skin Diseases, osteoporosis is a major cause of mortality, morbidity, and disability world wide. It is our hypothesis that the combination of the pharmacologic plus a non- pharmacologic intervention in elderly persons with low bone mineral density (BMD) and a high risk of falls will have a synergistic effect in increasing bone mineral density over time. It is also our hypothesis that since low BMD is a necessary but not sufficient cause for hip fractures a non- pharmacologic intervention targeted towards persons at risk for fall will improve their endurance gait and balance and decrease their risk for future falls as well as increase their BMD. This proposal is presented as an intervention development study because we did not have sufficient preliminary data on the effects of the non-pharmacologic intervention and we need to test the feasibility of recruitment and acceptance of a non- pharmacologic treatment which will require nasal inhalation and if that is not tolerated, self injections. Tests of feasibility of this two center randomized trial we will enroll 10 participants per center (total 80) in each of 4 arms: 1) pharmacologic (calcitonin plus Vitamin D), 2) non- pharmacologic (exercise), 3) combination pharmacologic and non- pharmacologic, and 4) control. Therefore our specific aims of the feasibility study are to assess the feasibility, acceptability, tolerance, and compliance for the pharmacologic intervention, to assess the feasibility of recruitment, enrollment, and adherence, and to pilot test the various measures proposed including obtaining and calculating costs of the interventions. Based on the feasibility study, we will conduct a full trial to reduce falls and fractures in people at high risk for hip fracture.
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