“Mixed results,” is the current status report on the Testosterone Trials (“T Trials”). In older men with low testosterone, 1 year of testosterone treatment not only improved bone density and corrected anemia, but also increased the volume of coronary artery plaque.
The T Trials were designed to determine whether testosterone treatment could alleviate problems, such as impaired cognition, anemia, cardiovascular disease, diminished sexual function, decreased mobility, and fatigue. The trials were conducted at 12 sites nationwide in 790 men aged ≥ 65 years. Participants were randomly assigned to apply testosterone gel or placebo to the skin daily. Serum testosterone was measured at 1, 2, 3,6, 9, and 12 months. The men were closely monitored for prostate and cardiovascular problems.
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After 1 year of testosterone treatment, 54% of men with unexplained anemia and 52% of men with anemia from known causes had clinically significant increases in hemoglobin, compared with 15% and 12% of men in the placebo group. Older men with low testosterone had significantly increased volumetric bone density and estimated bone strength compared with the controls.
However, the testosterone-treated group also had significantly higher levels of coronary artery plaque, although only 170 men had coronary computed tomograph arteriography. The researchers found no significant differences between the 2 groups in cognition in older men with age-associated memory impairment.
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The results illustrate the need for individualized decisions about testosterone treatment, said Evan Hadley, MD, director of National Institute on Aging’s Division of Geriatrics and Clinical Gerontology. The “diverse outcomes,” he notes, indicate the potential trade-offs between benefits and risks of testosterone treatment in older men. Clarifying the effects of testosterone will take longer, larger scale trials.