Testosterone Supplements in Frail Elderly Men

February 21, 2010 by  
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As we age, we tend to lose both muscle mass and bone density.  These adverse effects of aging often lead to an increased risk of generalized weakness, early fatigue, imbalance and falls, bone fractures, long-term disability, and hospitalization or other forms of chronic institutionalization.  In turn, these complications of frailty in the elderly are significantly associated with an increased risk of death.

While an elixir of eternal youth has not yet been discovered (despite many claims to the contrary over the centuries), some of the causes of aging-related frailty can be treated.  Sex hormone replacement therapy in the elderly has been a major focus of clinical intervention, in both men and women, in an effort to reverse many of the debilitating effects of aging, including declines in muscle mass, bone density, and sexual function.  However, the true risks and benefits of sex hormone replacement therapy have not always been well understood.  Indeed, within the past decade, old assumptions about the safety of hormone replacement therapy have been called into question by high-level prospective, randomized, placebo-controlled, blinded clinical research trials, including the recent and disturbing (but not altogether surprising) findings that long-term combination hormone replacement therapy in postmenopausal women is associated with a significant increase in the risk of both breast cancer and cardiovascular disease.

Although aging men do not experience an abrupt and total loss of testicular function, unlike the complete loss of ovarian function that occurs in women following menopause, testicular function does dramatically and progressively decline with advancing age.  Significant decreases in the levels of testosterone (and other “androgens”) in the blood often leads to decreased muscle mass and bone density which, in turn, can result in reduced strength and balance, and an increased risk of falls and serious injuries. 

Testosterone replacement therapy has been shown to be effective in improving muscle mass and bone density (and sexual function) in older men with very low testosterone levels (hypogonadism).  However, the role of testosterone replacement therapy in men with borderline-low circulating levels of androgen hormones has been much less clear.   As with sex hormone replacement therapy in postmenopausal women, there are known side effects associated with male sex hormone replacement therapy.  These include enlargement of the prostate gland (benign prostatic hypertrophy, or BPH), liver disease (especially with oral testosterone supplements), fluid retention, decreased fertility, breast enlargement and pain (gynecomastia), and a potential increase in the risk of prostate cancer, among others.

A newly published research study, in the Journal of Clinical Endocrinology & Metabolism, evaluated 274 men who were 65 years of age or older, and who were determined, by validated clinical criteria, to be either “intermediate-frail” or “frail.”  All of these men were also confirmed to have “borderline-low” levels of testosterone in their blood. 

In this randomized, prospective, placebo-controlled, double-blind study (which is the “gold standard” method of performing clinical research), these older men were randomly assigned to receive either transdermal testosterone therapy (50 mg per day) or a placebo gel that appeared identical to the testosterone gel.  These treatments were continued for 6 months.  The researchers then assessed both groups of men in terms of their muscle strength, muscle mass, body fat, overall level of physical function, and self-reported quality-of-life.

At the end of 6 months, the men who had been secretly randomized to the testosterone gel group were found to have experienced significant improvements in both muscle mass and muscle strength, as well as a decrease in total body fat.  Overall physical function in the “intermediate-frail” and “frail” older men also significantly improved.  Finally, and not surprisingly, self-reported physical health and sexual health satisfaction scores were substantially improved among the men who, unknown to them at the time, had received the testosterone gel.

Thus, the findings of this prospective, randomized, controlled clinical research trial certainly suggest a potential role for transdermal testosterone supplementation in frail older men with borderline-low testosterone levels.  At the same time, continued follow-up of the men in this study who elected to continue receiving testosterone supplementation is indicated, as the rather short duration of this study (6 months) is not long enough to identify the long-term benefits and risks of androgen replacement therapy.

If you are an older man who is experiencing significant frailty and disability due to progressive muscle mass and bone density loss, and you have borderline-low or low testosterone levels, then you might wish to discuss the potential benefits of a monitored testosterone supplementation regimen with your physician, or with an Endocrinologist who specialize in male endocrinology (Andrology).


On a related topic, please also see my recent column on the use of Vitamin D to decrease the risk of falls and fractures in the elderly:



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Disclaimer: As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity

Dr. Wascher is an oncologic surgeon, a professor of surgery, a cancer researcher, an oncology consultant, and a widely published author

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