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Sponsors and Collaborators: |
Washington University School of Medicine National Institute on Aging (NIA) |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00280267 |
The purpose of this study is to determine the feasibility of testosterone replacement therapy in frail elderly female hip fracture patients who have testosterone deficiency, and to obtain preliminary information about the effects of testosterone therapy on muscle strength and size, bone density, mobility, daily functioning, and quality of life.
Condition | Intervention | Phase |
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Hip Fracture Testosterone Deficiency Muscle Weakness |
Drug: Testosterone gel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety Study |
Official Title: | Testosterone Therapy After Hip Fracture in Elderly Women |
Enrollment: | 15 |
Study Start Date: | August 2004 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Hip fractures are common among 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 function. Such individuals are at high risk 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. 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. There is insufficient information regarding tolerability of testosterone therapy, and the appropriate medication dosage and target serum testosterone levels necessary to induces changes in skeletal muscle mass and functional measures in elderly women with physical frailty due to muscle weakness.
The goals of this project are to conduct a randomized, double-blinded, placebo-controlled prospective study to determine the feasibility, tolerability, and safety of 6 months of testosterone therapy in community-dwelling, physically frail, elderly female hip fracture patients. Twenty-seven female hip fracture patients will be recruited, using objective criteria for testosterone deficiency and frailty. We plan to evaluate two dosages of testosterone, administered as a 0.5% topical gel: a physiologic replacement dosage, and a supraphysiologic dosage. We plan to carefully monitor testosterone levels, side effects, biochemical parameters, and factors related to compliance with therapy. We plan to obtain preliminary information regarding the changes in measurements of muscle strength, total score on an Objective Physical Performance Test, total lean body mass by dual energy x-ray absorptiometry (DEXA), thigh cross-sectional areas by magnetic resonance imaging (MRI), and self-reported performance of activities of daily living, and quality of life. These data will be used to develop a full-scale proposal to test the long-term hypothesis that testosterone therapy combined with exercise training can improve physical function after a hip fracture.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria: -female, hip fracture repair within previous 4 months
Exclusion Criteria: -permanent nursing home residence
United States, Missouri | |
Washington University School of Medicine, Division of Geriatrics and Nutritional Science | |
Saint Louis, Missouri, United States, 63110 |
Principal Investigator: | Ellen F. Binder, MD | Washington University School of Medicine, Division of Geriatrics and Nutritional Science |
Responsible Party: | Washington University ( Ellen Binder, MD ) |
Study ID Numbers: | R21AG023716 |
Study First Received: | January 19, 2006 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00280267 History of Changes |
Health Authority: | United States: Food and Drug Administration |
hip fracture testosterone muscle weakness frail elderly aging |
Antineoplastic Agents, Hormonal Asthenia Hormone Antagonists Fractures, Bone Hormones, Hormone Substitutes, and Hormone Antagonists Wounds and Injuries Disorders of Environmental Origin Methyltestosterone Muscle Weakness Hormones Testosterone 17 beta-cypionate |
Hip Fractures Signs and Symptoms Anabolic Agents Testosterone Femoral Fractures Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Leg Injuries Androgens |
Antineoplastic Agents Fractures, Bone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Disorders of Environmental Origin Muscle Weakness Hormones Hip Fractures Signs and Symptoms Femoral Fractures Pathologic Processes Musculoskeletal Diseases Therapeutic Uses Neuromuscular Manifestations |
Antineoplastic Agents, Hormonal Nervous System Diseases Wounds and Injuries Hip Injuries Methyltestosterone Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Testosterone Muscular Diseases Neurologic Manifestations Leg Injuries Androgens |