- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00280267
Testosterone Therapy After Hip Fracture in Elderly Women
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine, Division of Geriatrics and Nutritional Science
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum testosterone levels, drug compliance, symptoms and side effects during the six months of treatment.
Time Frame: Six months
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Modified Physical Performance Test Score at 6 months
Time Frame: Six months
|
Six months
|
1-RM muscle strength at 6 months
Time Frame: Six months
|
Six months
|
Thigh cross-sectional area by MRI at 6 months
Time Frame: Six months
|
Six months
|
Self-report of ADL function at 6 months
Time Frame: Six months
|
Six months
|
SF-36 score (quality of life) at 6 months
Time Frame: Six months
|
Six months
|
Total and regional bone density by DEXA at 6 months
Time Frame: Six months
|
Six months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ellen F. Binder, MD, Washington University School of Medicine, Division of Geriatrics and Nutritional Science
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Leg Injuries
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Femoral Fractures
- Hip Injuries
- Muscle Weakness
- Fractures, Bone
- Hip Fractures
- Paresis
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Androgens
- Testosterone
Other Study ID Numbers
- R21AG023716 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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