Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture (Starting a Testosterone and Exercise Program after Hip Injury: STEP-HI)

PI: Ellen F. Binder, MD, Division of General Medicine & Geriatrics

The STEP-HI study is a multi-site, randomized, double-blinded, placebo controlled, parallel group study with a clinical Coordinating Center and Data Coordinating Center at Washinton University in St. Louis funded by the NIH (NIA).  After a comprehensive screening process, females aged 65 and older with recent hip fracture repairs randomize to receive Enhanced Usual Care (home exercise and health education), Exercise + Placebo gel (Placebo and supervised exercise training), or Exercise + Testosterone gel (Testosterone and supervised exercise training). The primary goal of the study is to establish that improvements from baseline to post-intervention on the Six Minute Walking Distance are significantly greater for the Exercise + Testosterone group compared to the Exercise + Placebo or the Enhanced Usual Care groups.

Trial-CARE staff provided project management to the study during the planning and start-up phase. Initially, Trial-CARE staff assisted the study leadership with acquiring site sub-contracts, submission of the sIRB application, development of the protocol, creation of the MOP & CRFs, and REDCap design. STEP-HI hired their own coordinator who was mentored through the completion of the above tasks, coordinator training meeting, site initiations, maintenance of multi-site regulatory documents, and overall project management. As study recruitment and intervention ended and a full-time coordinator was no longer necessary, Trial-CARE provided staff support to complete site closeout.

Clincaltrials.gov NCT02938923