Study finds that testosterone gel use in women recovering from hip fracture does not improve outcomes compared to supervised exercise alone

Results from a recent multi-center, randomized, controlled trial demonstrate that testosterone gel does not improve physical function compared to exercise alone in older women recovering from a hip fracture. The STEP-HI study was published in JAMA Open and is the largest such study of testosterone administration to women following a fracture of the hip.

Hip fractures are the most serious type of osteoporotic fracture, as they are accompanied by considerable pain, loss of muscular and bone strength, reduced mobility and independence with daily activities, and increased risk for future fractures and death. After a hip fracture patients undergo surgery to repair the broken bone followed by a period of rehabilitation. Even after standard rehabilitation, many patients do not recover to their level of mobility and function before the fracture. The STEP-HI study focused on interventions intended to improve outcomes after standard therapy was completed.

The study, "Effects of Exercise Training and Testosterone Therapy in Older Women after Hip Fracture: A Randomized Clinical Trial," provides valuable information that discourages adding low dose testosterone to exercise in women recovering from a hip fracture. Testosterone is a hormone present in all women that declines with age. It has effects on muscle that were hypothesized to augment the benefits of exercise during the recovery period.

The study was a randomized, double-blind clinical trial that enrolled women aged ≥ 65 years who had a recent surgical repair of a hip fracture, met objective criteria for mobility impairment, and were community-dwelling. Participants (n=129) were recruited from 8 clinical sites in the United States between February 2018 and February 2023. 

Key findings of the study include:

• 24 weeks of supervised exercise combined with testosterone therapy did not lead to significant improvement in Six Minute Walk Distance, which is a measure of long-distance mobility compared to supervised exercise alone.
• Adding testosterone therapy to exercise may not provide further benefits for long-distance mobility in older women recovering from a hip fracture.
• Adding testosterone therapy to exercise had some positive effects on short-distance mobility that will require further research to confirm.

Douglas P. Kiel, MD, PhD, who led the Boston site for this study and is a senior scientist at the Hinda and Arthur Marcus Institute for Aging Research, said that this was the largest clinical trial of testosterone use in women. “There remains a need to develop enhancements to exercise in women facing the uphill challenges of recovering from a hip fracture.”

This work is in part supported by the following grants: The National Institute on Aging provided funding and supervision for STEP-HI under award numbers: R21 AG023716, R34 AG040257, R01 AG051647, P30 AG067988, P30 AG024832, P30 AG028747. Support for STEP-HI at the Baltimore site was also provided by the Baltimore Veterans Affairs Medical Center Geriatric Research, Education, and Clinical Centers (GRECC).

Co-authors of the study include:

• Ellen F. Binder, MD^a, Jenna M. Bartley,PhD^b, Sarah D. Berry,MD,MPH^c, Peter Doré,MS^d,
• Steven R. Fisher, PT, PhD^e, Richard H. Fortinsky, PhD^b, Camelia Guild,MPH^d,
• Douglas P. Kiel, MD, MPH^c, George A. Kuchel, MD^b, Robin L. Marcus, PT, PhD^f,
• Christine M. McDonough, PT, PhD^g, Kelly M. Monroe, MSW^a, Denise Orwig, PhD^h,
• Rocco Paluch, MAⁱ, Dominic Reeds, MD^j, Jennifer Stevens-Lapsley, PT, PhD^k,
• Elena Volpi, MD, PhD^l, Kenneth B. Schechtman, PhD^d, Jay Magaziner, PhD^h.

^aDivision of General Medicine and Geriatrics, Washington University School of Medicine in St. Louis, St. Louis, MO

^bUConn Center on Aging, University of Connecticut, Farmington, CT

^cHinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife and the Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston MA

^dDivision of Biostatistics, Washington University School of Medicine in St. Louis, St. Louis, MO

^eDepartment of Physical Therapy, University of Texas Medical Branch, Galveston, TX

^fDepartment of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT

^gSchool of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA

^hDepartment of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD

ⁱJacobs School of Medicine, and Biomedical Sciences, University at Buffalo, Buffalo, New York

^jDivision of Nutritional Science and Obesity Medicine, Washington University School of Medicine in St. Louis, St. Louis, MO

^kDepartment of Physical Medicine and Rehabilitation, University of Colorado Anschutz Medical Campus, Denver, CO

^lSam and Ann Barshop Institute for Longevity and Aging Studies, Division of Geriatrics, Gerontology & Palliative Medicine, UT Health San Antonio, and San Antonio GRECC, San Antonio, TX, and Sealy Center on Aging, University of Texas Medical Branch, Galveston, TX.

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. Hebrew SeniorLife cares for more than 4,500 seniors a day across seven campuses throughout Greater Boston. Locations include: Hebrew Rehabilitation Center-Boston and Hebrew Rehabilitation Center-NewBridge in Dedham; NewBridge on the Charles, Dedham; Orchard Cove, Canton; Simon C. Fireman Community, Randolph; Center Communities of Brookline, Brookline; Jack Satter House, Revere; and Leyland Community, Dorchester. Founded in 1903, Hebrew SeniorLife also conducts influential research into aging at the Hinda and Arthur Marcus Institute for Aging Research, which has a portfolio of more than $98 million, making it one of the largest gerontological research facilities in the U.S. in a clinical setting. It also trains more than 500 geriatric care providers each year. For more information about Hebrew SeniorLife, visit our website or follow us on our blog, Facebook, Instagram, Threads, and LinkedIn.

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.