Researchers at Washington University School of Medicine in St. Louis are leading a national, multicenter study exploring whether testosterone plus exercise can restore physical abilities in elderly women who have broken a hip.
More than 265,000 older adults fracture a hip each year in the United States, with associated health-care costs estimated at more than $20 billion annually. About 25 percent of these patients die within a year, and more than 75 percent never recover their ability to function day to day.
This five-year study is funded with a $15.6 million grant from the National Institute on Aging of the National Institutes of Health (NIH). It will involve 300 women who recently have suffered a broken hip. They will be treated at one of six centers in the U.S., including Washington University.
“After a woman sustains a hip fracture, standard physical therapy often is completed within a few weeks, but many patients still have significant problems with mobility and their ability to perform daily activities,” said Ellen F. Binder, MD, the national study’s principal investigator and a professor of medicine in Washington University’s Division of Geriatrics and Nutritional Science. “Previously, we demonstrated that continuing physical therapy and exercise for six months — especially with the addition of weightlifting exercises — significantly improves strength and the ability to walk and live as patients had before the fractures. In this study, we want to learn whether testosterone supplementation can improve things even more.”
Earlier research in this area has focused primarily on whether anabolic hormones, such as testosterone, might improve balance, walking and other related abilities in older men, Binder said. Studies in women have been less common, but small studies of testosterone supplementation in women have shown promise for improving muscle strength, including a study led by Binder of women with hip fractures.
“We conducted a pilot study looking at whether short-term testosterone supplementation could improve function in women after a hip fracture, and we saw increased muscle mass and strength at six months,” she said.
In this new study, researchers will test whether combining testosterone with exercise can lead to even greater improvements in physical abilities after a hip fracture.
Study participants will be randomly assigned to one of three groups. Two of those groups will participate in a supervised exercise program, including weightlifting, at one of the study’s clinical centers. A third group will be given exercises to do at home. Women in the two supervised exercise groups will be asked to apply a gel to the skin. The gel some receive will be an inactive placebo; the gel others receive will contain testosterone. Neither the participants nor the researchers will know who received the testosterone gel.
In addition to Washington University, the study’s other clinical sites will be the University of Colorado Denver; the University of Texas Medical Branch at Galveston; the University of Connecticut (UConn) Health in Farmington, Conn.; the University of Maryland School of Medicine and John Hopkins University School of Medicine, both in Baltimore; and Hebrew SeniorLife and Harvard Medical School, Boston.
The study’s other principal investigators include Kenneth B. Schechtman, a professor of biostatistics who will lead the data coordinating center at Washington University; and Jay S. Magaziner, a professor of epidemiology and an expert on hip fracture recovery at the University of Maryland.
To be eligible for the study, volunteers must be women 65 and older who have suffered a recent hip fracture and lived either at home or in assisted living before the fracture. They also must be mentally fit enough to maintain the training regimen and understand why they are doing the exercises. Those who have significant cognitive impairments from Alzheimer’s disease or other dementias will not be eligible.
Women with other age-related health problems, such as diabetes, may be eligible to participate. All testing, medications and exercise training are provided free of charge to those who qualify for the study.
For more information or to volunteer for the study, contact study coordinator Kelly Monroe by calling 314-273-1160 or emailing firstname.lastname@example.org.