Hip FracturePhase 3STEP-HINCT02938923

Starting a Testosterone and Exercise Program After Hip Injury

A Phase 3 study testing Testosterone, Supervised exercise training and Home exercise program in people with Hip Fracture and Frailty, run by Washington University School of Medicine at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 years and older, women only
Conditions the study is for: Hip Fracture, Frailty, Sarcopenia
What is being tested?: Testosterone, Supervised exercise training and Home exercise program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 129 participants
Where: 8 sitesUnited States
Study dates: 5 Mar 2019to 6 Nov 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
Women only
No healthy volunteers
Older adult

Who may be able to join

Female 65 years and older.
Surgical repair of a non-pathologic fracture of the proximal femur (Including: femoral neck or intracapsular, intertrochanteric, and subtrochanteric fractures) with a surgical repair date that is within 24 weeks at randomization. If a revision of such a fracture is performed due to failure of the repair, that surgery revision date may be used to calculate the time frame for the screening and randomization dates.
Community-dwelling or in assisted living prior to the hip fracture event.
Functional impairment at the time of screening, defined as a modified Physical Performance Score (mPPT) of 12-28.
Serum total testosterone level <60 ng/dL.

Who cannot join

Cognitive impairment or dementia of severity sufficient to interfere with ability to fully participate in the study or provide one's own informed consent, or a score of 11 or greater on the Short Blessed Test of Orientation, Memory and Concentration.
Residence too far from research center (specific distance to be determined by each site) or planned travel greater than 2 weeks within the next 9 months.
Anticipated to be permanently living in a nursing home at the time of randomization.
Use of progestin or androgen containing compound within the previous 6 months.
Treatment with systemic corticosteroids (daily dose > 5 mg prednisone or equivalent) for at least 90 days within the previous 12 months.
Visual or hearing impairments that interfere with following directions for research procedures.

Show all 28Show fewer

Active or unstable cardiopulmonary disease (recent myocardial infarction, unstable angina, class III or IV Congestive Heart Failure) within prior 6 months, which would limit full participation in the study.
Respiratory disease requiring chronic continuous oxygen therapy, or oxygen therapy during walking or exercise, which would limit full participation in this study.
History of idiopathic deep venous thrombosis or pulmonary embolus (i.e., not related to period or immobilization or surgery), any pulmonary embolus less than 12 weeks prior to the first screening visit, recurrent or multiple venous thrombi; history of a hypercoagulable state such as Factor V Leiden thrombophilia.
Musculoskeletal or neurological conditions that limit participation in this study, could be made worse by exercise training, or not expected to improve with exercise.
Lower extremity amputation other than toes.
Severe lower extremity pain or ulceration that could limit full participation in this study.
History of: a) Breast, ovarian, endometrial or cervical cancer with diagnosis within the previous 10 years; b) Breast, ovarian, endometrial, or cervical cancer of Stage 2 or higher.
History of HIV or active viral hepatitis.
End Stage Renal Disease on dialysis or Glomerular Filtration Rate (GFR)<15 ml/min.
Allergy to gel components.
Recent history of alcohol or substance abuse, or current alcohol intake of ≥ 10 drinks/week.
Planned joint surgery during the intervention period.
Participation in another research study that in the site investigator's judgement could interfere or conflict with STEP-HI research assessments or interventions.
Current use of aldactone, flutamide or leflunomide.
Geriatric Depression Scale (GDS) score ≥ 12 at the screening assessment.
Uncontrolled hypertension, defined as a systolic BP > 160 mmHg or diastolic BP > 95 mmHg, on at least two occasions.
Elevated liver transaminase or alkaline phosphatase levels ≥ 2.5 times above normal range.
Erythrocytosis defined as hematocrit > 51% (all sites but University of Utah) or ≥ 52% at University of Colorado - Denver and University of Utah sites.
Severe anemia defined as Hgb < 7gm/dL.
Uncontrolled diabetes defined as HgbA1C > 10%.
Untreated or unstable thyroid disease, with serum Thyroid-stimulating Hormone (TSH) level ≥ 10 milli-international units per liter (mIU/L) or TSH level ≤ 0.4 mIU/L. Levels outside of the given range require site physician documentation addressing treatment or absence of thyroid disease and approval by the Central Coordinating Center (CCC).
Site investigator's judgement that the participant would not be able to complete research procedures or interventions.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

University of Colorado, Denver
Aurora, Colorado, 80045
University of Maryland School of Medicine/Johns Hopkins University
Baltimore, Maryland, 21201
University of Connecticut Heath - UConn Health
Farmington, Connecticut, 06030
University of Texas Medical Branch at Galveston (UTMB)
Galveston, Texas, 77555
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
HebrewSenior Life Harvard Medical School
Roslindale, Massachusetts, 02131
University of Utah
Salt Lake City, Utah, 84108
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture

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.

Read the 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
Being tested: Testosterone, Placebo gel, Supervised exercise training, Home exercise program, Health Education Modules
Medical subject headings: Hip Fractures, Frailty, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TestosteroneDrug
Also called T
Topical testosterone gel 1%
Placebo gelDrug
Also called P
Inactive skin gel
Supervised exercise trainingBehavioural
Also called EX
Multicomponent exercise program focused primarily on progressive resistance exercise training
Home exercise programBehavioural
Also called EUC
Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
Health Education ModulesBehavioural
Also called EUC
30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.

Study groups in NCT02938923
Study group	Role	What they receive
Exercise + Testosterone (EX + T)	Experimental	Supervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression) daily, both for six months duration. Receives: Drug: Testosterone; Behavioral: Supervised exercise training
Exercise + Placebo (EX + P)	Placebo comparator	Supervised exercise training 2 times per week and placebo gel daily, both for six months duration. Receives: Drug: Placebo gel; Behavioral: Supervised exercise training
Enhanced Usual Care (EUC)	Other	Home exercise program 3 times per week and monthly health education modules, both for six months duration. Receives: Behavioral: Home exercise program; Behavioral: Health Education Modules

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Six Minute Walk Distance
Walking endurance was measured using a 6-Minute Walk Distance. Participants were asked to walk back and forth on a measured path marked clearly at both ends for turning purposes, while being told when each minute has passed, and receiving verbal encouragement every 60 seconds. Total distance was measured in meters with higher distances equating to higher walking endurance. Each individual participant distance from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in walking distance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Measured: Baseline to 6 months

Secondary outcomes (10)

Change in Total Lean Body Mass
Total lean body mass measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more gains in total lean body mass. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months.
Measured: Baseline to 6 months
Change in Appendicular Lean Body Mass
Lean body mass of the arms and legs, measured by dual x-ray absorptiometry (DXA). Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more gains in appendicular lean body mass. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months.
Measured: Baseline to 6 months
Change in 1-repetition Maximum (1-RM) Leg Press Strength
Muscle strength measured as the maximal amount of weight that the participant was able to lift for one repetition (1-RM). The 1-RM is defined as the greatest resistance that could be overcome through a defined range of motion using proper techniques. Subjects were asked to move against progressively heavier resistance loads until a repetition failure was achieved. Each individual participant measure from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent the increased ability to lift more weight. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Measured: Baseline to 6 months
Change in Total Modified Physical Performance Test (mPPT) Score
A modified version of the Physical Performance Test (mPPT) was used to measure physical function. Participants were asked to complete 9 standardized tasks (book lift, putting on a lab coat, picking up a penny from the floor, standing balance, standing up five times from a 16-inch chair, 50 foot walk including a turn, 360 degree turn, stair climb for 10 steps, and climbing 2 additional flights of steps) for a total score ranging from 0 (significant impairment) to 36 (excellent functioning). Each individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in physical functioning.
Measured: Baseline to 6 months
Change in Short Physical Performance Battery (SPPB) Score
The Short Physical Performance Battery (SPPB) is a well validated objective physical performance measure used to identify risk for disability. The SPPB consists of: chair rise, progressive Romberg balance, and 4 meter gait speed. Each task was scored (0-4) with a total range of 0-12. Participants who score 0 are unable to complete the tasks and participants with higher scores are considered to have higher functional mobility. Each individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in physical performance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Measured: Baseline to 6 months
Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
The OARS Multidimensional Functional Assessment Questionnaire Activities of Daily Living (ADL) is a standardized, valid and reliable, self-report questionnaire used to determine the effect of services on the functional status of older adults by asking respondents about their ability to perform ADLS on 2 subscales: Basic (BADL) and Instrumental (IADL). Both subscales are scored from 0 (significant impairment) to 14 (excellent functioning). The individual participant score from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in functioning. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Measured: Baseline to 6 months
Change in Functional Status Questionnaire (FSQ) Total Score
The Functional Status Questionnaire (FSQ) is a self-reported measure asking about the amount of difficulty a participant experienced when performing daily tasks in the previous 4 weeks. There are a total of 6 subscales, but only the basic ADL and Intermediate ADL were used in the STEP-HI study for a total of 9 items. Scores range from 0 (high amount of difficulty completing tasks) to 36 (no difficulty completing tasks). Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Measured: Baseline to 6 months
Change in Hip Rating Questionnaire Total Score
The Hip Rating Questionnaire (HRQ) Standardized is a 14-item scale with weighted questions regarding quality of life (pain level and ability to walk) and function (ability to use stairs, put on socks/shoes, use public transportation, bathe, shop, do housework, and get in and out of a chair/bed) related to the hip fracture event. The scale scores range from 16 to 100. Higher scores are associated with less pain, higher function, and better quality of life. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Measured: Baseline to 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Patient-Reported Outcomes Measurement Information System (PROMIS®) Global Health instrument is a 10 item self report questionnaire used to measure overall quality of life using 2 summary scores: Physical and Mental Health. Each summary score is standardized to the general population, with the average T-score for the US population being 50 and standard deviation of 10. Each individual participant T-score from Baseline was subtracted from Month 6 T-score to represent change over the length of the study. Higher scores represent larger increases in Physical and Mental Health. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.
Measured: Baseline to 6 months
Change in Bone Mineral Density (BMD) of the Non-fractured Proximal Femur
Bone mineral density (BMD) measured by dual x-ray absorptiometry (DXA) of the non-fractured proximal femur in participants without hardware in the contralateral hip. Baseline DXA scans were completed prior to the first administration of study drug. All scans were completed prior to exercise or 1-RM measurements if scheduled for the same day. DXA scans were reviewed for quality control, proper positioning, and artifacts centrally. Per the protocol: In addition to the primary analysis (unadjusted baseline to 6 month comparison), additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline. DXA was not performed at 3 months.
Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 20196 Nov 2023

First posted19 Oct 2016 (estimated)
Study start5 Mar 2019
Primary completion31 Aug 2023
Study completion6 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Hip FractureStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02938923
Sponsor's protocol ID: R01AG051647
Other IDs: 201609077
Acronym: STEP-HI
Status last verified: Jan 2025
First submitted: 14 Oct 2016
Last updated: 4 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Binder EF, Christensen JC, Stevens-Lapsley J, Bartley J, Berry SD, Dobs AS, Fortinsky RH, Hildreth KL, Kiel DP, Kuchel GA, Marcus RL, McDonough CM, Orwig D, Sinacore DR, Schwartz RS, Volpi E, Magaziner J, Schechtman KB. A multi-center trial of exercise and testosterone therapy in women after hip fracture: Design, methods and impact of the COVID-19 pandemic. Contemp Clin Trials. 2021 May;104:106356. doi: 10.1016/j.cct.2021.106356. Epub 2021 Mar 11.
PubMed 33716173
Earp JE, Zhao S, Xu F, Kuo CL, Bartley JM, Fortinsky RH, Kositsawat J, Rehbein CO, Binder EF, Stevens-Lapsley J, Kuchel GA. Testosterone therapy effects adipose distribution in older females post hip-fracture: The STEP-HI study. Obes Pillars. 2026 Jan 12;17:100247. doi: 10.1016/j.obpill.2026.100247. eCollection 2026 Mar.
PubMed 41624165
Binder EF, Bartley JM, Berry SD, Dore PM, Fisher SR, Fortinsky RH, Guild C, Kiel DP, Kuchel GA, Marcus RL, McDonough CM, Monroe KM, Orwig DL, Paluch RA, Reeds D, Stevens-Lapsley J, Volpi E, Schechtman KB, Magaziner JS. Combining Exercise Training and Testosterone Therapy in Older Women After Hip Fracture: The STEP-HI Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2510512. doi: 10.1001/jamanetworkopen.2025.10512.
PubMed 40372752
Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
PubMed 36070134

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
Pelvic and Acetabular Fracture: A Prospective Observational Study
Pelvic Fracture, Acetabular Fracture
RecruitingObservational study
Z1 Hip System: Post-Market Clinical Follow Up Study
Hip Osteoarthritis, Acute Traumatic Fracture of the Femoral Head or Neck
Not yet recruiting
Trochanteric Bursa Repair and Lateral Hip Pain After Hemiarthroplasty for Femoral Neck Fracture
Femoral Neck Fracture

All Hip Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combining Testosterone Therapy and Exercise to Improve Function Post Hip Fracture
ClinicalTrials.gov ID: NCT02938923
Acronym / sponsor ID: STEP-HI / R01AG051647
Conditions: Hip Fracture, Frailty, Sarcopenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Collaborators: University of Maryland, Baltimore, University of Colorado, Denver, The University of Texas Medical Branch, Galveston, Johns Hopkins University, Harvard University, University of Connecticut, University of Utah, University of Pittsburgh Medical Center
Study start: 5 Mar 2019 (actual)
Primary completion: 31 Aug 2023 (actual)
Study completion: 6 Nov 2023 (actual)
First posted: 19 Oct 2016 (estimated)
Results: Posted 4 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Exercise + Testosterone (EX + T)	Experimental	Drug: Testosterone, Behavioral: Supervised exercise trainingSupervised exercise training 2 times per week and topical testosterone 1% gel (12.5 mg per pump depression) daily, both for six months duration.
Exercise + Placebo (EX + P)	Placebo comparator	Drug: Placebo gel, Behavioral: Supervised exercise trainingSupervised exercise training 2 times per week and placebo gel daily, both for six months duration.
Enhanced Usual Care (EUC)	Other	Behavioral: Home exercise program, Behavioral: Health Education ModulesHome exercise program 3 times per week and monthly health education modules, both for six months duration.

Who may qualify

Ages: 65 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Female 65 years and older.
Surgical repair of a non-pathologic fracture of the proximal femur (Including: femoral neck or intracapsular, intertrochanteric, and subtrochanteric fractures) with a surgical repair date that is within 24 weeks at randomization. If a revision of such a fracture is performed due to failure of the repair, that surgery revision date may be used to calculate the time frame for the screening and randomization dates.
Community-dwelling or in assisted living prior to the hip fracture event.
Functional impairment at the time of screening, defined as a modified Physical Performance Score (mPPT) of 12-28.
Serum total testosterone level <60 ng/dL.

Key exclusion criteria (28 listed)

Cognitive impairment or dementia of severity sufficient to interfere with ability to fully participate in the study or provide one's own informed consent, or a score of 11 or greater on the Short Blessed Test of Orientation, Memory and Concentration.
Residence too far from research center (specific distance to be determined by each site) or planned travel greater than 2 weeks within the next 9 months.
Anticipated to be permanently living in a nursing home at the time of randomization.
Use of progestin or androgen containing compound within the previous 6 months.
Treatment with systemic corticosteroids (daily dose > 5 mg prednisone or equivalent) for at least 90 days within the previous 12 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TestosteroneAlso: TTopical testosterone gel 1%	Drug	Exercise + Testosterone (EX + T)
Placebo gelAlso: PInactive skin gel	Drug	Exercise + Placebo (EX + P)
Supervised exercise trainingAlso: EXMulticomponent exercise program focused primarily on progressive resistance exercise training	Behavioural	Exercise + Placebo (EX + P), Exercise + Testosterone (EX + T)
Home exercise programAlso: EUCFlexibility exercises performed at home 3 times per week and reviewed by study staff once a month.	Behavioural	Enhanced Usual Care (EUC)
Health Education ModulesAlso: EUC30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.	Behavioural	Enhanced Usual Care (EUC)

Primary outcome

Change in Six Minute Walk Distance
Time frame: Baseline to 6 months
Walking endurance was measured using a 6-Minute Walk Distance. Participants were asked to walk back and forth on a measured path marked clearly at both ends for turning purposes, while being told when each minute has passed, and receiving verbal encouragement every 60 seconds. Total distance was measured in meters with higher distances equating to higher walking endurance. Each individual participant distance from Baseline was subtracted from Month 6 to represent change over the length of the study. Higher positive values represent more improvement in walking distance. In addition to the primary analysis (unadjusted baseline to 6 month comparison), statistical contracts were evaluated to determine if there was significant between-group differences in the change from baseline to 3 months and additional analysis of covariance were performed to adjust for baseline values and covariates that differed across groups at baseline.

10 secondary outcomes

Change in Total Lean Body Mass
Time frame: Baseline to 6 months
Change in Appendicular Lean Body Mass
Time frame: Baseline to 6 months
Change in 1-repetition Maximum (1-RM) Leg Press Strength
Time frame: Baseline to 6 months
Change in Total Modified Physical Performance Test (mPPT) Score
Time frame: Baseline to 6 months
Change in Short Physical Performance Battery (SPPB) Score
Time frame: Baseline to 6 months
Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire
Time frame: Baseline to 6 months
Change in Functional Status Questionnaire (FSQ) Total Score
Time frame: Baseline to 6 months
Change in Hip Rating Questionnaire Total Score
Time frame: Baseline to 6 months
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
Time frame: Baseline to 6 months
Change in Bone Mineral Density (BMD) of the Non-fractured Proximal Femur
Time frame: Baseline to 6 months

Results and safety

Results posted to the registry on 4 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exercise + Testosterone (EX + T)	55	54
Exercise + Placebo (EX + P)	54	51
Enhanced Usual Care (EUC)	20	19

Primary outcome: Change in Six Minute Walk Distance

Time frame: Baseline to 6 months. Least squares mean (95% Confidence Interval). Unit: Meters

Measure	Exercise + Testosterone (EX + T) n = 53	Exercise + Placebo (EX + P) n = 51	Enhanced Usual Care (EUC) n = 18
Unadjusted baseline to 6 months	42.69 (26.35 to 59.04)	40.50 (23.82 to 57.18)	37.65 (8.29 to 67.02)
Baseline to 6 month with covariates	42.38 (24.96 to 59.80)	41.75 (23.98 to 59.52)	33.95 (4.30 to 63.60)
Unadjusted baseline to 3 months	24.10 (9.72 to 38.48)	29.18 (14.37 to 43.99)	37.60 (12.00 to 63.20)
Baseline to 3 months with covariates	24.72 (11.87 to 37.56)	30.23 (16.98 to 43.48)	38.36 (15.76 to 60.96)

Exercise + Testosterone (EX + T) vs Exercise + Placebo (EX + P): Mean Difference (Final Values): 2.19 (95% CI -21.16 to 25.54), p = 0.853, Mixed Models Analysis
Exercise + Testosterone (EX + T) vs Enhanced Usual Care (EUC): Mean Difference (Final Values): 5.04 (95% CI -28.57 to 38.65), p = 0.767, Mixed Models Analysis
Exercise + Placebo (EX + P) vs Enhanced Usual Care (EUC): Mean Difference (Final Values): 2.84 (95% CI -30.93 to 36.62), p = 0.868, Mixed Models Analysis

Population analysed: Randomized participants (N=122) who completed the primary outcome measure at baseline and one other follow-up time point (3 Months or 6 Months post randomization).

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from randomization until 30 days after the participant's final assessment visit (either 6 months after randomization or early withdrawal) or any subsequent event believed to be reasonably related to participation in the study. After consent, but prior to randomization, adverse events that were a direct result of study procedures or occurred while the participant was under study staff supervision were also collected.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exercise + Testosterone (EX + T)	7 of 54 (13%)	36 of 54 (66.7%)	1 of 55
Exercise + Placebo (EX + P)	3 of 55 (5.5%)	24 of 55 (43.6%)	0 of 54
Enhanced Usual Care (EUC)	1 of 20 (5%)	11 of 20 (55%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33716173Binder EF, Christensen JC, Stevens-Lapsley J, Bartley J, Berry SD, Dobs AS, Fortinsky RH, Hildreth KL, Kiel DP, Kuchel GA, Marcus RL, McDonough CM, Orwig D, Sinacore DR, Schwartz RS, Volpi E, Magaziner J, Schechtman KB. A multi-center trial of exercise and testosterone therapy in women after hip fracture: Design, methods and impact of the COVID-19 pandemic. Contemp Clin Trials. 2021 May;104:106356. doi: 10.1016/j.cct.2021.106356. Epub 2021 Mar 11.
Derived from this study: PubMed 41624165Earp JE, Zhao S, Xu F, Kuo CL, Bartley JM, Fortinsky RH, Kositsawat J, Rehbein CO, Binder EF, Stevens-Lapsley J, Kuchel GA. Testosterone therapy effects adipose distribution in older females post hip-fracture: The STEP-HI study. Obes Pillars. 2026 Jan 12;17:100247. doi: 10.1016/j.obpill.2026.100247. eCollection 2026 Mar.
Derived from this study: PubMed 40372752Binder EF, Bartley JM, Berry SD, Dore PM, Fisher SR, Fortinsky RH, Guild C, Kiel DP, Kuchel GA, Marcus RL, McDonough CM, Monroe KM, Orwig DL, Paluch RA, Reeds D, Stevens-Lapsley J, Volpi E, Schechtman KB, Magaziner JS. Combining Exercise Training and Testosterone Therapy in Older Women After Hip Fracture: The STEP-HI Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2510512. doi: 10.1001/jamanetworkopen.2025.10512.
Derived from this study: PubMed 36070134Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ellen F Binder, MD principal investigator

Washington University School of Medicine

Kenneth B Schechtman, PhD principal investigator

Washington University School of Medicine

Jay Magaziner, PhD principal investigator

University of Maryland, Baltimore

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Six Minute Walk Distance (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02938923, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.