Status:
COMPLETED
Testosterone Effects on Bone and Frailty
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Aging
Frailty
Eligibility:
MALE
60+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the effects of testosterone replacement on bone density, muscle strength, physical performance, quality of life and prostate symptoms in men selected for low bon...
Detailed Description
The hypothesis being tested is that testosterone supplementation can increase bone mineral density and specific parameters of frailty in older men with osteoporosis and characteristics of frailty. One...
Eligibility Criteria
Inclusion
- Men over age 60 years who have sustained a femoral fracture in the preceding 3 years
- Total testosterone levels below 375 ng/dl or bioavailable testosterone levels at least 1.5 SD lower than the young adult mean
- Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits
Exclusion
- Prostate specific antigen level over 4.0 ng/dl or the history of prostate cancer
- Disease of bone metabolism (i.e., Paget's disease, osteomalacia, hyperparathyroidism)
- History of pituitary disease
- History of sleep apnea
- Consumption of more than 3 alcoholic drinks/day
- Use of androgen, estrogen, or DHEA in the preceding year
- Use of antiresorptive agents such as calcitonin or bisphosphonates
- Metastatic or advanced cancer
- Current chemotherapy or radiation treatment
- Plans to move in the next three years
- Advanced liver or renal disease such that the subjects is unlikely to complete the three year intervention
- Hemaglobin \>16.5 g/dl
- Bilateral hip replacement or repair
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00182871
Start Date
November 1 2001
End Date
July 1 2007
Last Update
October 30 2009
Active Locations (1)
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1
Center on Aging, University of Connecticut Health Center
Farmington, Connecticut, United States, 06030