Summary
Hip fractures are common among older women and can have a devastating impact on their ability to remain independent. Many women who were high functioning before the hip fracture do not return to their pre-fracture level of function, have persistent weakness and mobility impairments, and may require ongoing supportive services. Age-associated androgen deficiency may contribute to deficits in muscle mass, strength and power that are common in older female hip fracture patients.
The STEP-HI Study was a randomized, double-blinded, placebo-controlled Phase III clinical trial that was carefully designed to evaluate interventions aimed at improving functional outcomes in older female hip fracture patients.
This study is funded by grant R01AG051647 from the National Institute on Aging and is being lead by a team of experts in diverse fields including geriatric medicine, endocrinology, osteoporosis, exercise science, physical therapy, and epidemiology.
For more information go to Clinicaltrials.gov – NCT02938923
Objectives
The primary goal of STEP-HI was to determine in female hip fracture patients, whether change in mobility over 6 months, as measured by the 6-Minute Walk Distance, is significantly better for those who received Supervised Exercise plus topical Testosterone therapy, compared to Supervised Exercise plus placebo gel, and compared with Enhanced Usual Care.
Secondary outcomes included measures of muscle strength, body composition, bone mineral density, objective physical performance, and self-reported ADL performance and quality of life.
Design and Outcomes
Female hip fracture patients age 65 yrs. and older were evaluated for eligibility between 6-22 weeks following surgical repair of the fracture. After consent to participate, eligible participants underwent a comprehensive screening assessment. Those who met eligibility criteria completed baseline assessments and were then randomized to one of the three study groups:
- Enhanced Usual Care
- Supervised Exercise + topical placebo gel
- Supervised Exercise + topical testosterone gel
Women assigned to Enhanced Usual Care received a home exercise program, nutritional counseling, vitamin D and calcium supplements, and a monthly health education program.
Women assigned to Supervised Exercise were expected to attend a twice-weekly exercise session on-site at one of the research centers. They received either active Testosterone gel or a Placebo gel. They also received nutritional counseling and vitamin D and calcium supplements. Testosterone blood levels were monitored monthly.
Primary and secondary study outcomes were measured again at 3 and 6 months post-randomization. Safety and adherence measures were obtained monthly.
Participants were carefully monitored during the 6-month intervention period. All clinical examinations, laboratory tests, and clinical research testing were provided at no cost to participants. Local transportation to the research centers was provided at no cost to participants.