Data from the STEP-HI Randomized Clinical Trial
Description
This phase 3 double-blind, placebo-controlled randomized clinical trial, Starting a Testosterone and Exercise Program After Hip Injury (STEP-HI), was conducted at 8 US sites between December 2018 and August 2023. Participants were women aged 65 years or older with a recent surgical repair of a nonpathologic femur fracture, met objective criteria for mobility impairment, and were community dwelling after discharge from rehabilitation. During the first 14 months of the trial, participants were randomly assigned to 1 of 3 treatment groups: exercise plus topical testosterone gel, exercise plus placebo gel, or enhanced usual care. Statistical analysis, using a modified intention-to-treat approach, was performed from November 2023 to November 2024.
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Steps to reproduce
STEP-HI was a phase 3, multicenter, 3-group, double-blind, placebo-controlled randomized clinical trial conducted at 8 sites in the US between December 2018 and August 2023. Refer to the "Methods" section of the published manuscript.
Institutions
- Washington University in St. LouisMO, Saint Louis
- University of PittsburghPA, Pittsburgh
- Hebrew SeniorLifeMA, Boston
- University of Texas Health Science Center at San AntonioTX, San Antonio
- University of Maryland School of MedicineMD, Baltimore
- University of Texas Medical Branch at GalvestonTX, Galveston
- University of UtahUT, Salt Lake City
- University of ConnecticutCT, Storrs
Categories
Funders
Additional Metadata for Digital Commons Data@Becker
| Keywords | Hip Fracture, Testosterone, Frailty, Rehabilitation, Aging |