Study Suggests Low Testosterone Drugs May Actually Increase Fracture Risks

Although testosterone replacement therapy is known to improve bone density and structure, the findings of a new study suggests that the low testosterone drugs may actually increase the risk of fractures among men with hypogonadism, which is a hormonal deficiency when the body does not produce enough testosterone naturally.

In findings published this week in The New England Journal of Medicine, researchers from the Perelman School of Medicine, University of Pennsylvania indicate middle-aged and older men taking drugs for low testosterone were more likely to suffer from hip, wrist, humerus, and spinal fractures, compared to those given a placebo.

Testosterone gels, injections, and other therapies were intended to improve bone density and quality, and to reduce the risk of fractures among those suffering from the condition. However, the findings of this new study indicate that the hormone therapies may not be as effective in that role as previously thought.

Testosterone Linked to Increased Fracture Risks

In this new report, a team of medical researchers conducted a randomized study involving 5,204 men between the ages of 45 and 80 years, who were diagnosed with hypogonadism and also had preexisting cardiovascular disease, or had an increased risk of developing the condition.

Half of the participants were given transdermal testosterone gel to apply daily to each shoulder, while the other half applied a placebo gel. Participants were assessed multiple times throughout the first year to report any incidence of fractures, and then annually for approximately three years afterwards, to determine whether the testosterone treatment was effective in reducing fractures.

After a mean follow up period of 3.19 years, researchers found fractures were more common among those given testosterone than those given the placebo. Among those in the testosterone group, 3.50% reported a clinically confirmed fracture, compared to 2.46% of those in the placebo group, according to the data. Fractures occurred among 91 participants given testosterone gel, while only 64 occurred among those given the placebo.

The findings revealed the most common areas where fractures occurred included the rib, wrist, and ankle. Researchers indicate the fracture sites reported among the participants are mostly associated with trauma and falls. They also note these fracture sites are specifically associated with low bone mineral density, and increase the risk of sustaining future fractures or death.

Researchers suggest further data is needed to investigate the increased risk of fractures associated with testosterone among those with hypogonadism.

Testosterone Health Concerns

Although drug treatments for low testosterone were initially introduced as a “niche” therapy for men who experienced drops in testosterone levels associated with a condition known as hypogonadism, in prior decades the drugs became popular among aging men, to provide increased strength and stamina.

Amid aggressive marketing by drug makers that encouraged men experiencing normal effects of aging to speak to their doctors about “low T”, prescriptions for testosterone drugs increased more than 300% between 2001 and 2013. However, following a series of studies and warnings about serious heart risks associated with use of the drugs, prescriptions have dropped substantially in recent years.

The FDA required a label change for all prescription “Low T” drugs, such as AndroGel, Axiron, Testim, Depo-Testosterone and other gels, creams patches and injections after concluding there is evidence of a possible link between testosterone drugs and heart problems.

Thousands of testosterone lawsuits were filed against drug makers by users who experienced heart problems, most of which have now settled.