What is the purpose of the STEP-HI Study?
Many older women do not recover fully after a hip fracture even after they receive rehabilitation services and physical therapy. They often have ongoing muscle weakness and problems with mobility. This may partially be related to low levels of testosterone (a hormone present in men and women) in the body.
The STEP-HI study is evaluating whether 6 months of testosterone gel therapy combined with resistance (weight) training exercises can improve physical function after a hip fracture more effectively than resistance training alone, or Enhanced Usual Care with home-based exercise.
Testosterone skin gel is approved by the U.S. Food and Drug Administration to increase testosterone levels in men who do not produce enough of the hormone naturally. Older women can also have testosterone deficiency but there is not as much information available about the potential benefits of testosterone therapy as for older men. In this study testosterone gel therapy is investigational and is being compared to a placebo, which is an inactive substance containing no active study drug.
Frequently asked questions
Study interventions occur for 6 months. Some research testing is conducted before and after the intervention period.
There are 3 study groups. If you are eligible you will be assigned to a group randomly:
- Enhanced Usual Care (home exercise)
- Supervised Exercise at the research center + inactive skin gel
- Supervised Exercise at the research center + testosterone skin gel
- Exams and laboratory testing
- Nutritional counseling
- Vitamin D and Calcium supplements
- Transportation to all study visits
If you, or someone you know, is interested in learning more about the STEP-HI Study, please contact the study coordinator at a site near you:
Washington University School of Medicine in St. Louis
University of Connecticut Health – Farmington
Heather McAbee-Sevick, MS