Researchers from the University of Texas Medical Branch (UTMB) joined a multi-center team in conducting the largest randomized clinical trial to date on testosterone therapy in women recovering from hip fractures, finding that the hormone treatment did not improve physical function compared to supervised exercise alone.
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. “Hip fractures can affect many aspects of function in older people and require multiple strategies to restore function,” said Ellen Binder, MD, one of the project principal investigators and Professor of Medicine at Washington University in St. Louis.
The study 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. , “Although testosterone did not provide the functional benefits to older women recovering from a hip fracture that we were expecting, our study offers valuable information on the importance of exercise and other treatments during recovery”, said Dr. Elena Volpi, the principal investigator of the UTMB study site". "Findings also suggested that Testosterone helped reduce the use of assistive devices, which may have implication for the clinical management of these patients” said Dr. Steve Fisher, the lead Physical Therapist for the UTMB site.
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.
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, Camelia Guild, Kelly M. Monroe, Dominic Reeds and Kenneth B. Schechtman from Washington University. Jenna M. Bartley, Richard Harold Fortinsky and George A. Kuchel from University of Connecticut. Sarah D. Berry and Douglas P. Kiel from Beth Israel Deaconess Medical Center and Harvard Medical School. Steven R. Fisher from the University of Texas Medical Branch. Robin L. Marcus from University of Utah. Christine M. McDonough from University of Pittsburgh. Denise Orwig and Jay Magaziner from University of Maryland. Rocco Paluch from University at Buffalo. Jennifer Stevens-Lapsley from University of Colorado and Elena Volpi from UT Health San Antonio.