Can testosterone plus exercise improve healing after hip fracture?

BOSTON — Researchers at the Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife and Harvard Medical School are participating in a 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, titled the Study of Testosterone and Exercise after Hip Injury (STEP-HI), 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 across six clinical centers who recently will have suffered a broken hip. The principal investigator, Ellen Binder, MD, is at Washington University in St. Louis.

“After a hip fracture, physical therapy is generally completed within a few weeks, leaving many patients with significant limitations in mobility and an inability to perform daily activities,” said Douglas Kiel, MD MPH, the principal investigator from the Hebrew SeniorLife site and a Professor of Medicine at Harvard Medical School. “We know that continuing physical therapy and exercise for six months — especially weightlifting exercises — improves mobility and function after the fracture. In this study, we hope to learn whether testosterone supplementation can improve function even more.”

Earlier research in this area has focused on the effect of anabolic hormones, such as testosterone, in older men, Kiel said. Based on small studies, there is good reason to believe that testosterone supplementation may be a promising agent to improve muscle strength in older women as well.

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.
STEP-HI 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 will be either an inactive placebo, or it will contain testosterone. Neither the participants nor the researchers will know who received the testosterone gel.

In addition to Hebrew SeniorLife, the study’s other clinical sites will be the Washington University St. Louis; the University of Colorado Denver; the University of Texas Medical Branch at Galveston; the University of Connecticut (UConn) Health in Farmington, Conn.; and the University of Maryland School of Medicine and John Hopkins University School of Medicine, both in Baltimore).

To be eligible for the STEP-HI 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 and arthritis, may be eligible to participate. All testing, medications, exercise training, and transportation will be provided free of charge to those who qualify for the study.

For more information or to volunteer for the study, contact study coordinator-Evelyn O’Neill at 617-971-5800 or e-mailing oneill@hsl.harvard.edu.

About the Hinda and Arthur Marcus Institute for Aging Research

Scientists at the Marcus Institute seek to transform the human experience of aging by conducting research that will ensure a life of health, dignity and productivity into advanced age. The Marcus Institute carries out rigorous studies that discover the mechanisms of age-related disease and disability; lead to the prevention, treatment and cure of disease; advance the standard of care for older people; and inform public decision-making.

About Hebrew SeniorLife

Hebrew SeniorLife, an affiliate of Harvard Medical School, is a national senior services leader uniquely dedicated to rethinking, researching and redefining the possibilities of aging. Based in Boston, the non-profit, non-sectarian organization has provided communities and health care for seniors, research into aging, and education for geriatric care providers since 1903. For more information about Hebrew SeniorLife, visit http://www.hebrewseniorlife.org, follow us on Twitter @H_SeniorLife, like us on Facebook or read our blog.