Mixed Results for Trials of Testosterone in Older Men

T Trials’ mixed results. In older men with low testosterone, 1 year of testosterone treatment improved bone density and corrected anemia of both known and unknown causes, but also increased the volume of coronary artery plaque.

In older men with low testosterone, 1 year of testosterone treatment improved bone density and corrected anemia of both known and unknown causes, but also increased the volume of coronary artery plaque, according to results reported from the Testosterone Trials (T Trials). Testosterone treatment had no effect on memory or other cognitive function. The results were reported in two journals of the American Medical Association.

The T Trials were conducted at 12 sites across the country in 790 men age 65 and older with low levels of testosterone and symptoms to which low testosterone might contribute. The studies were funded primarily by NIA; NHLBI, NINDS and NICHD also contributed. Additional funding, and the study drug and placebo, were provided by AbbVie Pharmaceuticals.

“A number of older men have testosterone levels below those found in healthy younger men,” said NIA director Dr. Richard Hodes. “In most cases, these low levels are not due to diseases known to affect testosterone levels. Many of these men also have problems that could be related to low testosterone, including impaired cognition, anemia, cardiovascular disease, diminished sexual function, decreased mobility and fatigue. The T Trials were designed to determine if testosterone treatment might help alleviate these symptoms and conditions while monitoring for adverse effects.”

“The results on diverse outcomes indicate the potential trade-offs between benefits and risks of testosterone treatment in older men,” said Dr. Evan Hadley, director of NIA’s Division of Geriatrics and Clinical Gerontology. “However, clarifying the effects of testosterone on many major clinical outcomes such as cardiovascular events, fractures and disability will require longer, larger scale trials. The results also illustrate that decisions about testosterone treatment need to be individualized, taking into account each patient’s balance of risks for the various conditions that testosterone treatment could affect.”