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.
Public Health Relevance Statement
Data not available.
NIH Spending Category
No NIH Spending Category available.
Project Terms
accidental fallsaerobic exerciseagingbalancebiopsyblood chemistrybone densitycalcitoninclinical trialsdietary calciumdisease /disorder proneness /riskfrail elderlyhealth care cost /financinghiphip fractureshormone therapyhuman old age (65+)human subjecthuman therapy evaluationhuman very old age (85+)injection /infusionlongitudinal human studynutrition related tagosteoporosisphoton absorptiometryquality of lifequestionnairesskeletal disorder chemotherapytherapy complianceurinalysisvitamin Dvitamin therapy
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