Hip fractures are common in elderly women and can have a devastating impact on their ability to remain independent. A significant functional decline following a hip fracture has been documented, and many patients have persistent strength and mobility deficits that impair their capacity for independent living. Such individuals are at high rsk for continued supportive services, recurrent injury, and institutionalization. High-risk patients include those with deficits in skeletal muscle strength during the post-fracture period. Age-associated androgen deficiency contributes to deficits in muscle mass and strength that are common in this patient population. Exercise training can reverse deficits in skeletal muscle strength and functional performance to a modest degree. We have observed a high rate of testosterone deficiency in elderly female hip fracture patients with physical frailty. The role of testosterone therapy for improving deficits in muscle mass, strength, and functional capacity in the frail elderly is unclear, particularly for elderly women. Expanding from our R21 project which showed study feasibility, the proposed project will develop a prospective randomized, double-blinded, placebo-controlled trial to determine, in community-dwelling elderly (e65 yrs) female hip fracture patients, the efficacy of 6 months of testosterone therapy and exercise training, alone and in combination, at improving muscle strength and physical function after the fracture event.
Our specific aims are to: 1) Finalize the protocol for the proposed clinical trial (study hypothese and experimental design, eligibility criteria, details of study treatments, safety assessments, sample size, analysis plan, including plans for an interim analysis);2) Establish the research team and finalize the collaborative arrangements for the trial (clinical trial sites and related agreements);3) Develop a plan for data management and quality control;4) Develop a detailed manual of procedures including establishing the means to assure standardization of procedures across sites, and plans for staff training and certification. We will bring together an outstandin team of investigators with expertise conducting clinical trials of hip fracture patients, testosterone replacement therapy, exercise training, clinical trial design, MRI and Quantitative CT imaging techniques, data analysis and management. These efforts will lead to submission of a grant application to the National Institute on Aging (NIA) to test the role for the proposed interventions in elderly female hip fracture patients. The proposed clinical trial will also be the first to elucidate the role of testosterone therapy combined with exercise training for improving recovery in elderly women after hip fracture, which is a problem with a large public health impact.
More than 300,000 hip fractures occur annually in the U.S., with associated health care costs estimated at $10-14 billion. A significant functional decline following hip fracture has been documented, and many patients have persistent strength and mobility deficits that impair their ability to live independently. This project will plan a clinica trial of testosterone therapy and exercise training to determine whether they are effective at improving physical function for elderly female hip fracture patients, which is a problem with a large public health impact.