TOM: Testosterone in Older Men With Sarcopenia

Sarcopenia Clinical Trial

Official title: Testosterone Replacement for Older Men With Sarcopenia

Status Terminated

Clinical Trial Summary

The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.

Clinical Trial Description

The primary objective of this study is to determine whether testosterone replacement in older men, who have low testosterone levels and mild to moderate physical impairment, will increase their maximal voluntary muscle strength of major upper and lower extremity muscle groups. The second objective is to determine whether testosterone replacement will improve the power of knee extension, physical performance tests, the level of physical activity (measured by 3D accelerometer), self-reported disability, exercise tolerance and mobility. The third objective is to determine whether testosterone supplementation improves fatigue, affect, and overall sense of well being in older men with low testosterone levels. A fourth objective is to define the Minimum Clinically Important Differences in physical measures perceived by the participants (MCID).

Participant involvement will require 15-17 clinic visits over 28 weeks. Five to 7 of these visits are for physical testing, including body composition, muscle performance, and physical function. Throughout the study, hormone measurements will be obtained. ;

Related Conditions & MeSH terms

• Hypogonadism
• Muscular Diseases
• Sarcopenia

• NCT number: NCT00240981
• Study type: Interventional
• Source: Boston Medical Center
• Status: Terminated
• Phase: Phase 4
• Start date: January 2005
• Completion date: December 2009