Testosterone Therapy After Hip Fracture in Elderly Women
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hip Fracture; Testosterone Deficiency; Muscle Weakness
Intervention: Testosterone gel (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s): Ellen F. Binder, MD, Principal Investigator, Affiliation: Washington University School of Medicine, Division of Geriatrics and Nutritional Science
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.
Clinical Details
Official title: Testosterone Therapy After Hip Fracture in Elderly Women
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Serum testosterone levels, drug compliance, symptoms and side effects during the six months of treatment.
Secondary outcome: Modified Physical Performance Test Score at 6 months1-RM muscle strength at 6 months Thigh cross-sectional area by MRI at 6 months Self-report of ADL function at 6 months SF-36 score (quality of life) at 6 months Total and regional bone density by DEXA at 6 months
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.
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria: - female, hip fracture repair within previous 4 months
- 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: - permanent nursing home residence
- 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
Locations and Contacts
Washington University School of Medicine, Division of Geriatrics and Nutritional Science, Saint Louis, Missouri 63110, United States
Additional Information
Starting date: August 2004
Last updated: February 3, 2009
|