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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00280267 |
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Date of registration:
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19/01/2006 |
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Primary sponsor: |
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Public title:
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Testosterone Therapy After Hip Fracture in Elderly Women
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Scientific title:
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Testosterone Therapy After Hip Fracture in Elderly Women |
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Date of first enrolment:
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August 2004 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00280267 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Ellen F. Binder, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Washington University School of Medicine, Division of Geriatrics and Nutritional Science |
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Key inclusion & exclusion criteria
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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
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hip Fracture
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Muscle Weakness
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Testosterone Deficiency
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Intervention(s)
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Drug: Testosterone gel
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Primary Outcome(s)
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Serum testosterone levels, drug compliance, symptoms and side effects during the six months of treatment.
[Time Frame: Six months]
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Secondary Outcome(s)
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1-RM muscle strength at 6 months
[Time Frame: Six months]
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Modified Physical Performance Test Score at 6 months
[Time Frame: Six months]
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Self-report of ADL function at 6 months
[Time Frame: Six months]
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SF-36 score (quality of life) at 6 months
[Time Frame: Six months]
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Thigh cross-sectional area by MRI at 6 months
[Time Frame: Six months]
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Total and regional bone density by DEXA at 6 months
[Time Frame: Six months]
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Secondary ID(s)
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R21AG023716
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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