Testosterone Therapy After Hip Fracture in Elderly Women

NCT ID: NCT00280267

Last Updated: 2009-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2006-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Hip Fracture; Testosterone Deficiency; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Testosterone gel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age 65 years and older
• serum total testosterone level < 30 ng/dl
• modified Physical Performance Test Score between 13-28
• able to ambulate 50 ft

Exclusion Criteria

• dementia severe enough to prohibit informed consent
• clinically significant visual or hearing impairments
• history of a hormone dependent neoplasia
• active or unstable cardiopulmonary disease
• history of sleep apnea
• elevated liver function tests
• hematocrit > 51%
• history of alcohol or substance abuse
• symptoms of depression severe enough to cause weight loss of >5% in previous 3 months or interfere with daily activities or medication compliance

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Washington University

Principal Investigators

Ellen F. Binder, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine, Division of Geriatrics and Nutritional Science

Locations

Washington University School of Medicine, Division of Geriatrics and Nutritional Science

St Louis, Missouri, United States

Countries

United States

Other Identifiers

R21AG023716

Identifier Type: NIH

Identifier Source: org_study_id

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