NCT02938923

Starting a Testosterone and Exercise Program After Hip Injury

Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized controlled double-blinded multi-center clinical trial enrolling female hip fracture patients who are 65 and older. It will compare the effects of six months of supervised exercise training combined with daily topical testosterone gel, to six months of supervised exercise and inactive gel, and to Enhanced Usual Care. The randomization protocol is that for every nine participants randomized, 4 will be assigned to the topical testosterone gel and supervised exercise training group; 4 will be assigned to topical inactive gel and supervised exercise training group; and 1 will be assigned to the enhanced usual care group. All participants will receive nutritional counseling, and calcium and vitamin D supplements.

Detailed description

Hip fractures are common among older women and can have a devastating impact on their ability to remain independent. A clinically important functional decline and failure to recover following a hip fracture has been documented as late as a year after the fracture, even among women who were functioning at high levels before the event. Age-associated androgen deficiency in women contributes to deficits in muscle mass, strength and power that are common in this patient population before the fracture, and are exacerbated afterward. A pilot study of testosterone (T) supplementation in elderly female hip fracture patients has demonstrated the feasibility of T treatment in this population, and showed gains in lean body mass (LBM) and muscle strength with active drug, compared to placebo. The benefits of exercise in restoring muscle strength and physical function after a hip fracture have been documented. However, it remains unclear whether T treatment can augment the effects of exercise on mobility and patient-reported function after hip fracture. The STEP-HI study is a 3-group, multi-center, randomized, placebo-controlled, double-blinded, parallel group clinical trial in older female hip fracture patients. Between 120 and 168 female hip fracture patients, age 65 years and older, will be randomized from multiple clinical sites in the USA, using objective screening criteria for T deficiency (serum total testosterone level \< 60 ng/dL) and physical frailty (Modified Physical Performance Test (PPT) Score of 12-28). The primary study aim is to compare supervised exercise training (EX) with inactive (placebo) gel (EX+P) and EX combined with T therapy (EX+T), to ascertain the incremental impact of adding T to EX in older adult women with a recent hip fracture. The study team will carefully monitor testosterone levels, adverse events, biochemical parameters, and factors related to adherence to the interventions. Information from this study has the potential to alter treatment of hip fracture in older women, a problem that contributes to significant morbidity and mortality, and has a large public health impact. The STEP-HI study is highly aligned with NIA's mission of identifying interventions that target common geriatric conditions and improve treatment options for older adults with multiple morbidities or risk factors.

Conditions

• Hip Fracture
• Frailty
• Sarcopenia

Interventions

Type	Name	Description
DRUG	Testosterone	Topical testosterone gel 1%
DRUG	Placebo gel	Inactive skin gel
BEHAVIORAL	Supervised exercise training	Multicomponent exercise program focused primarily on progressive resistance exercise training
BEHAVIORAL	Home exercise program	Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
BEHAVIORAL	Health Education Modules	30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.

Timeline

• Start date: 2019-03-05
• Primary completion: 2023-08-31
• Completion: 2023-11-06
• First posted: 2016-10-19
• Last updated: 2025-02-04
• Results posted: 2025-02-04

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study