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Testosterone treatment in frail, elderly men lost effect after 6 months
O’Connell MD. J Clin Endocrinol Metab. 2011;96:454-458.
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The effects of 6 months of testosterone therapy on muscle strength, lean body mass and quality of life in frail men were not sustained after the treatment period, researchers found.
Using a single center, randomized, double blind, placebo-controlled trial, researchers in Britain assessed the androgen effects of testosterone in frail and intermediate-frail men. Testosterone is among the first wave of pharmacologic anabolic interventions in frail men for whom resistance training is not practical.
The study included 274 men, aged 65 to 90 years, with low testosterone levels (≤12 nmol/L or calculated free testosterone ≤250 pmol/L) and at least one criteria for frailty (exhaustion, weight loss, physical activity, walk time, grip strength). Participants were randomly assigned testosterone gel (25 mg to 75 mg per day) or placebo for 6 months.
In the testosterone-treated group, the mean testosterone level increased from 11.1 nmol/L at baseline to 18.4 nmol/L at 6 months, before decreasing to 10.5 nmol/L at 12 months. The adjusted mean difference between isometric knee extension peak torque in the testosterone-treated group and the placebo group was 8.1 Newton meters (95% CI, –0.2 to 16.5) at 6 months.
Lean body mass increased in the testosterone-treated arm, for a difference between the two groups of 1.2 kg (95% CI, 0.8-1.7) at 6 months. The treatment group showed improvement in sexual and somatic symptoms; prostate-specific antigen and hematocrit levels increased slightly in the treatment group. No differences between groups remained at 12 months.
The decline in muscle mass and strength after testosterone treatment for 6 months may not sufficiently interrupt the progression of frailty in the study’s cohort of intermediate-frail and frail elderly men, researchers wrote.
“The main finding of this study was that the increased [lean body mass], muscle strength and [quality of life] after 6-month [testosterone] treatment in intermediate-frail and frail elderly men were not maintained 6 months posttreatment. Our results also indicate that any potentially adverse changes in safety parameters of [testosterone] treatment did not persist posttreatment,” researchers concluded.
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