Using testosterone gel to treat women recovering from hip fractures provides no added benefits, clinical trial finds

Hip fractures, often a result of a fall, are the most serious type of osteoporotic fracture because they are accompanied by considerable pain, loss of muscle and bone strength, reduced mobility and independence with daily activities, and increased risk for future fractures and death. More than 200,000 American women every year experience hip fractures, and up to three-quarters of them never fully regain their ability to resume normal activities like walking, even after undergoing weeks of exercise rehabilitation.

In a pressing effort to test new treatments, researchers conducted a clinical trial to see whether applying a testosterone gel with exercise could improve function and mobility in these patients. Testosterone is a hormone present in all women that declines with age and it has effects on muscle; therefore, it was hypothesized that it would augment the benefits of exercise during the recovery period.

Results published today in the journal JAMA Network Open found that testosterone gel did not improve physical function compared to a placebo in older women who were engaging in a supervised exercise program and recovering from a hip fracture. Testosterone therapy did appear to have some positive effects on short-distance mobility, which may require further study to confirm.

“Hip fractures can affect many aspects of function in older people and require multiple strategies to restore function,” said study co-author and one of the study principal investigators, Jay Magaziner, Ph.D., MSHyg, Professor of Epidemiology in the University of Maryland School of Medicine (UMSOM). “This study considered two approaches: the use of testosterone gel and high intensity exercise. What we learned is that the addition of testosterone to exercise is not a useful method of improving physical function in this group of women.”

The study, called STEP-HI, involved 129 women 65 and older living in the community who had a recent surgical repair of a hip fracture and experiencing mobility impairment. It is the largest such study of testosterone administration to women following a fracture of the hip and was conducted at UMSOM and seven other clinical sites throughout the country.

“Having a hip fracture is a sentinel event for patients and their families,” said study co-author and clinical site principal investigator Denise Orwig, Ph.D., Professor of Epidemiology and Gerontology at UMSOM who has spent more than 25 years doing research to identify strategies to maximize functional recovery after hip fracture. “While I’m disappointed that testosterone did not lead to the improvements we were expecting, the results are further evidence of how powerful exercise can be in helping hip fracture patients achieve restoration of function.”

Ellen Binder, MD, lead study principal investigator and Professor of Medicine in the Division of General Medicine and Geriatrics at the Washington University School of Medicine, pointed out one bright spot in the study findings regarding the use of testosterone gel: “It is notable that at the end of the intervention period, women assigned to exercise and testosterone had a significant reduction in the use of walking aids and greater improvement in a short-distance performance measure than women assigned to exercise and placebo. This finding will need further exploration to confirm whether testosterone therapy can facilitate recovery after a hip fracture in older women.”

Hip fractures, often a result of a fall, are the most serious type of osteoporotic fracture because they are accompanied by considerable pain, loss of muscle and bone strength, reduced mobility and independence with daily activities, and increased risk for future fractures and death. More than 200,000 American women every year experience hip fractures, and up to three-quarters of them never fully regain their ability to resume normal activities like walking, even after undergoing weeks of exercise rehabilitation.

In a pressing effort to test new treatments, researchers conducted a clinical trial to see whether applying a testosterone gel with exercise could improve function and mobility in these patients. Testosterone is a hormone present in all women that declines with age and it has effects on muscle; therefore, it was hypothesized that it would augment the benefits of exercise during the recovery period.

Results published today in the journal JAMA Network Open found that testosterone gel did not improve physical function compared to a placebo in older women who were engaging in a supervised exercise program and recovering from a hip fracture. Testosterone therapy did appear to have some positive effects on short-distance mobility, which may require further study to confirm.

“Hip fractures can affect many aspects of function in older people and require multiple strategies to restore function,” said study co-author and one of the study principal investigators, Jay Magaziner, Ph.D., MSHyg, Professor of Epidemiology in the University of Maryland School of Medicine (UMSOM). “This study considered two approaches: the use of testosterone gel and high intensity exercise. What we learned is that the addition of testosterone to exercise is not a useful method of improving physical function in this group of women.”

The study, called STEP-HI, involved 129 women 65 and older living in the community who had a recent surgical repair of a hip fracture and experiencing mobility impairment. It is the largest such study of testosterone administration to women following a fracture of the hip and was conducted at UMSOM and seven other clinical sites throughout the country.

“Having a hip fracture is a sentinel event for patients and their families,” said study co-author and clinical site principal investigator Denise Orwig, Ph.D., Professor of Epidemiology and Gerontology at UMSOM who has spent more than 25 years doing research to identify strategies to maximize functional recovery after hip fracture. “While I’m disappointed that testosterone did not lead to the improvements we were expecting, the results are further evidence of how powerful exercise can be in helping hip fracture patients achieve restoration of function.”

Ellen Binder, MD, lead study principal investigator and Professor of Medicine in the Division of General Medicine and Geriatrics at the Washington University School of Medicine, pointed out one bright spot in the study findings regarding the use of testosterone gel: “It is notable that at the end of the intervention period, women assigned to exercise and testosterone had a significant reduction in the use of walking aids and greater improvement in a short-distance performance measure than women assigned to exercise and placebo. This finding will need further exploration to confirm whether testosterone therapy can facilitate recovery after a hip fracture in older women.”