Testosterone is a male hormone, or androgen, largely produced in the testicles. With effects on bone density, muscle size and strength, body fat distribution, facial and body hair, sperm production, sex drive and red blood cell production, testosterone plays multiple roles in maintaining men’s health. Should Older Men Take Testosterone Supplements?
But when men age, the testosterone levels drop. There is a link between the decline of testosterone and loss of muscle mass, loss of muscle strength, gain of abdominal fat, cognitive decline, and bone loss. Some men have much more of a testosterone decline than others do, but it’s not yet clear when a man might benefit from testosterone supplement.
Should older men take testosterone supplement? This seems to be common question that many people want to find answer. Then The testosterone trials were designed to determine if testosterone treatment might help to alleviate the symptoms and conditions.
The T Trials are a coordinated set of seven double-blind, placebo-controlled trials that are being 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 the National Institute on Aging (NIA), part of the National Institutes of Health.
To enroll in these trials overall, participants had to qualify for at least one of the three main trials including the Sexual Function Trial, the Physical Function Trial, or the Vitality Trial, but they could participate in more than one if they qualified. In the Sexual Function Trial, testosterone increased sexual activity, sexual desire, and erectile function.
Bone mineral density
A second trial examined the effect of 12 months of testosterone gel or placebo on bone mineral density in a group of 211 men with average testosterone concentrations less than 275 ng/L . The treatment increased median serum concentrations of total testosterone, free testosterone, and estradiol to within the normal ranges for young men.
The study showed significantly greater increases – measured by quantitative computed tomography – with testosterone treatment, compared with placebo, in spine trabecular, spine peripheral, hip trabecular, and peripheral volumetric bone mineral density, as well as in mean estimated strength of spine trabecular bone, spine peripheral bone, and hip trabecular and peripheral bone.
Researchers also noted that the magnitude of the increase in spine trabecular bone mineral density from baseline was significantly associated with changes in total testosterone and estradiol.
However, there were no significant differences in fracture rate, with six fractures reported in each group during the year of treatment. In the observation year after treatment, three fractures were reported in the testosterone arm and four in the placebo arm.
The primary hypothesis of the Vitality Trial was that testosterone treatment of elderly men with low vitality would increase the proportion whose score on the Functional Assessment of Chronic Illness Therapy (FACIT)–Fatigue Scale would increase by ≥4. The sample size estimate was based on providing 90% power to detect a difference of 15% (20% of men in the placebo group and 35% of men in the testosterone group) in the proportion of men showing would exhibit an increase at least this great. The inclusion criterion for the Vitality Trial was low vitality, as defined by both self-reported decreased energy and a score of <40 on the FACIT-Fatigue Scale.
The fourth study looked at mean change in cognitive function from baseline in 493 men with a serum testosterone level less than 275 ng/dL, impaired sexual function, physical function, or vitality, and who met the criteria for age-associated memory impairment. Half the participants were assigned to 12 months of testosterone gel, and half were assigned to placebo gel
Researchers found no significant differences between the two groups from baseline to 6 months and 12 months in mean change in delayed paragraph recall score, visual memory, executive function, or spatial ability.
“The lack of association between testosterone treatment and cognition was apparent across all cognitive domains assessed among men with, in spite of an increase in circulating total and free testosterone concentrations in the testosterone group to levels typical of men aged 19-40 years,” wrote Susan M. Resnick, PhD, of the National Institute on Aging, and her coauthors.
The primary aim was to determine if testosterone treatment would increase hemoglobin by 1.0 g/dL in men with unexplained mild to moderate anemia of the elderly, defined as a hemoglobin concentration 10.0–12.7 g/dL not due to nutrient deficiency, renal insufficiency, inflammation, or known hematologic disease. We expect to enroll about 100 men who met this criterion, which would provide >90% power to detect this difference.
The primary hypothesis was that testosterone treatment would decrease progression of noncalcified coronary artery plaque volume, as assessed by computed tomography (CT) angiography. Data using similar CT angiography techniques suggested that scans at baseline and 12 months for 60 men/arm would provide 80% power to detect a 13 mm3 or larger difference between treatment arms after 1 year of treatment, a value chosen to be more conservative than the 14 mm3 treatment effect of statins (Dr Budoff, unpublished). Dr Budoff trained the site technicians who performed the CT angiography.