Testosterone Therapy After Hip Fracture in Elderly Women

Phase 2

Completed

• Conditions: Hip Fracture; Testosterone Deficiency; Muscle Weakness

• Registration Number: NCT00280267
• Lead Sponsor: Washington University School of Medicine

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 contin...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2006-01-19
• Study First Submitted QC: 2006-01-19
• Study First Posted: 2006-01-20
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Serum testosterone levels, drug compliance, symptoms and side effects during the six months of treatment.	Six months

Secondary Outcome Measures

Name	Time	Method
Modified Physical Performance Test Score at 6 months	Six months
1-RM muscle strength at 6 months	Six months
Thigh cross-sectional area by MRI at 6 months	Six months
Self-report of ADL function at 6 months	Six months
SF-36 score (quality of life) at 6 months	Six months
Total and regional bone density by DEXA at 6 months	Six months

Trial Locations

Locations (1)

Washington University School of Medicine, Division of Geriatrics and Nutritional Science; 🇺🇸 Saint Louis, Missouri, United States