NCT02938923.

Study name	Combining testosterone therapy and exercise to improve function post hip fracture
Methods	Multicenter, randomised, placebo‐controlled trial. Blinded participants, care providers, investigators and outcomes assessors
Participants	Community‐dwelling or in assisted living prior to the hip fracture event. Female 65 years and older. Surgical repair of a non‐pathologic fracture of the proximal femur (including: intracapsular, intertrochanteric and subtrochanteric fractures) with a surgical repair date that is within 6 to 14 weeks at screening, and within 16 weeks at randomisation. Functional impairment at the time of screening, defined as a modified Physical Performance Score (mPPT) of 12 to 28. Serum total testosterone level < 40 ng/dL. Aim: 300 participants
Interventions	1. Exercise plus testosterone gel 2. Exercise plus placebo gel 3. Enhanced usual care
Outcomes	Follow‐up: 6 months Change in 6‐Minute Walk Test distance Change in total lean body mass Change in appendicular lean body mass Change in 1 repetition maximum (1 RM) leg press strength Change in Total Modified Physical Performance Test score Change in Short Physical Performance Battery score Change in Older Adult Resources and Services Activities of Daily Living Questionnaire ADL Total Score Change in Functional Status Questionnaire Total Score Change in Hip Rating Questionnaire Total Score Change in Patient‐Reported Outcomes Measurement Information System Global Health score Change in bone mineral density of the non‐fractured proximal femur
Starting date	Study start date: September 2017 Estimated completion date: May 2022
Contact information	Ellen F Binder, MD Professor of Medicine, Washington University School of Medicine 314‐286‐2707 ebinder@wustl.edu Kelly M Monroe, MSW 314‐273‐1160 monroek@wustl.edu
Notes	RM: repetition maximum