Status:
COMPLETED
Testosterone Therapy After Hip Fracture in Elderly Women
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Hip Fracture
Testosterone Deficiency
Eligibility:
FEMALE
65+ years
Phase:
PHASE2
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 ...
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, an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00280267
Start Date
August 1 2004
End Date
December 1 2006
Last Update
February 4 2009
Active Locations (1)
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1
Washington University School of Medicine, Division of Geriatrics and Nutritional Science
St Louis, Missouri, United States, 63110