NCT00182871

Testosterone Effects on Bone and Frailty

Testosterone Effects on Bone and Frailty in Men With Osteoporosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (planned)
• Sponsor: National Institute on Aging (NIA) · NIH
• Sex: Male
• Age: 60 Years
• Healthy volunteers: Not accepted

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 bone mineral density or fracture and some aspect of frailty.

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 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.

Conditions

• Aging
• Frailty
• Osteoporosis

Interventions

Type	Name	Description
DRUG	testosterone

Timeline

• Start date: 2001-11-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2005-09-16
• Last updated: 2009-10-30

Locations

1 site across 1 country: United States