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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 |
Estimated Enrollment: | 27 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | August 2006 |
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
Contact: Toni Gordon, BSN | 314-286-2716 | tgordon@wustl.edu |
Contact: Ellen F. Binder, MD | 314-286-2707 | ebinder@wustl.edu |
United States, Missouri | |
Washington University School of Medicine, Division of Geriatrics and Nutritional Science | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Toni Gordon, BSN 314-286-2716 tgordon@wustl.edu | |
Contact: Ellen F. Binder, MD 314-286-2707 ebinder@im.wustl.edu | |
Principal Investigator: Ellen F. Binder, MD |
Principal Investigator: | Ellen F. Binder, MD | Washington University School of Medicine, Division of Geriatrics and Nutritional Science |
Study ID Numbers: | R21AG023716 |
Study First Received: | January 19, 2006 |
Last Updated: | January 19, 2006 |
ClinicalTrials.gov Identifier: | NCT00280267 |
Health Authority: | United States: Food and Drug Administration |
hip fracture testosterone muscle weakness frail elderly aging |
Asthenia Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Methyltestosterone Muscle Weakness Testosterone 17 beta-cypionate Hip Fractures |
Signs and Symptoms Testosterone Femoral Fractures Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Leg Injuries |
Neuromuscular Manifestations Antineoplastic Agents, Hormonal Antineoplastic Agents Nervous System Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hip Injuries |
Hormones Pharmacologic Actions Anabolic Agents Pathologic Processes Therapeutic Uses Androgens |