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Report of National Institute on Aging Advisory Panel on Testosterone Replacement in Men.

The development of interventions to prevent or treat ageassociated diseases and disability is an important part of the mission of the National Institute on Aging. In the last decade, there has been increased interest in the potential of T replacement therapy for older men with low levels of T. Whether the gradual decline in serum T concentrations to levels significantly lower than those found in young men contributes to frailty, and whether treatment with T can prevent or reverse these changes, remains unknown. Several recent studies of T replacement in older men have included relatively small numbers of participants (maximum 108 subjects) and have been of limited duration. These studies have shown increases in bone mineral density, muscle strength, and lean body mass; decreases in body fat; and improved serum lipid profiles (1–7). However, results have not been consistent in all trials, and their implications for clinical outcomes are not clear. The studies have also been too small to adequately address many potential adverse effects such as an increase in prostate cancer risk. The Advisory Panel considered the following questions.