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,”, co-authored by Ellen Binder, MD, Professor of Medicine, WashU Medicine Division of General Medicine and Geriatrics, 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 finding 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.
“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”.
Study principal investigator, Ellen Binder, MD
“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,” shares Dr. Binder.
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).