Testosterone Effects on Bone and Frailty
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Testosterone Effects on Bone and Frailty in Men With Osteoporosis|
- Bone density and strength
- Physical performance
- quality of life
- prostate specific antigen
- prostate symptoms
|Study Start Date:||November 2001|
|Study Completion Date:||July 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
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 hundred and eighty men, age 60 years and older, who have sustained a hip fracture or other fragility fracture following mild to moderate trauma (such as a fall from standing height) in the previous 5 years or who have low femoral neck bone mineral density plus a component of frailty (weight loss, perception of exhaustion, physical strength, physical activity level and walking time) will be randomly assigned to receive either testosterone or placebo, delivered by topical gel applied daily, in a two year double-blind study.
Bone mineral density (BMD) by dual x-ray absorptiometry (DXA), will be performed at baseline and yearly to assess changes in BMD. Blood and urine samples will be collected at baseline and yearly; these tests will be correlated to changes in BMD.
To determine the effects of testosterone on frailty, strength of the upper and lower extremities will be measured every 6 months using the hand-held dynamometer and sitting leg press, respectively. Changes in lean body mass and percent body fat will be measured by total body DXA at baseline, 6 months and then annually. In addition, physical performance, emotional and sexual function, and disability will be assessed also.
The safety of testosterone supplementation on prostate and cardiovascular parameters will also be monitored; participants will be screened for prostate cancer at baseline, 6 months then yearly for 2 years. Fasting lipoprotein levels will be measured yearly while on testosterone replacement, and cardiovascular specific adverse effects such as angina, myocardial infarction, stroke and sudden death will be tracked.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00182871
|United States, Connecticut|
|Center on Aging, University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030|
|Principal Investigator:||Anne Kenny, MD||Center on Aging, University of Connecticut Health Center|