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 is a randomized, double-blinded, placebo-controlled Phase III clinical trial that has been carefully designed to evaluate interventions aimed at improving functional outcomes in older female hip fracture patients.
300 female hip fracture patients, age 65 yrs. and older are being recruited from 6 clinical sites in the USA. Study enrollment does not begin until patients have completed their standard rehabilitation care, typically between 6-22 weeks after surgical repair of the fracture.
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 is 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 receive Supervised Exercise plus topical Testosterone therapy, compared to Supervised Exercise plus placebo gel, and compared with Enhanced Usual Care.
Secondary outcomes include 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 will be evaluated for eligibility between 6-22 weeks following surgical repair of the fracture. After consent to participate, eligible participants will undergo a comprehensive screening assessment. Those who meet eligibility criteria will undergo baseline assessments and then will be 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 will receive a home exercise program, nutritional counseling, vitamin D and calcium supplements, and a monthly health education program.
Women assigned to Supervised Exercise will be expected to attend a twice-weekly exercise session on-site at one of the research centers. They will receive either active Testosterone gel or a Placebo gel. They will also receive nutritional counseling and vitamin D and calcium supplements. Testosterone blood levels will be monitored monthly.
Primary and secondary study outcomes will be measured again at 3 and 6 months post-randomization. Safety and adherence measures will be obtained monthly.
Participants will be carefully monitored during the 6-month intervention period. All clinical examinations, laboratory tests, and clinical research testing will be provided at no cost to participants. Local transportation to the research centers will also be provided at no cost to participants.