Combining Exercise Training and Testosterone Therapy in Older Women After Hip Fracture
作者:Ellen F. Binder, Jenna M. Bartley, Sarah D. Berry, Peter Doré, Steven R. Fisher, Richard H. Fortinsky, Camelia Guild, Douglas P. Kiel, George A. Kuchel, Robin L. Marcus, Christine M. McDonough, Kelly Monroe, Denise Orwig, Rocco A. Paluch, Dominic N. Reeds, Jennifer E. Stevens‐Lapsley, Elena Volpi, Kenneth B. Schechtman, Jay Magaziner · 发表于:JAMA Network Open · 年份:2025 · DOI:10.1001/jamanetworkopen.2025.10512 · 被引用次数:10 · 研究领域:Bone health and osteoporosis research、Total Knee Arthroplasty Outcomes、Hip and Femur Fractures
Importance: Despite receiving postacute rehabilitation services, many older women with a recent hip fracture repair are unable to return to their prefracture level of function. Whether testosterone therapy can enhance recovery after hip fracture in older women with persistent mobility impairments has not been fully examined. Objective: To evaluate the effects of a supervised exercise program combined with topical testosterone therapy on functional outcomes in older women with a recent hip fracture. Design, Setting, and Participants: 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. Interventions: For 24 weeks, the 2 exercise groups underwent a supervised, multimodal high-intensity exercise program that included progressive resistance training with trained and certified exercise interven...