Phase 3
N=129
Starting a Testosterone and Exercise Program After Hip Injury
Hip Fracture · Frailty · Sarcopenia
Bottom Line
View on ClinicalTrials.gov: NCT02938923 ↗Enrolled (actual)
129
Serious AEs
8.5%
Results posted
Feb 2025
Primary outcome: Primary: Change in Six Minute Walk Distance — 42.69; 40.50; 37.65; 42.38 Meters — p=0.853
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Testosterone (Drug); Placebo gel (Drug); Supervised exercise training (Behavioral); Home exercise program (Behavioral); Health Education Modules (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Six Minute Walk Distance |
42.69; 40.50; 37.65; 42.38; 41.75; 33.95 | 0.853 |
| SECONDARY Change in Total Lean Body Mass |
922.91; 565.19; -14.02; 930.80; 547.43; 94.16 | 0.336 |
| SECONDARY Change in Appendicular Lean Body Mass |
446.35; 429.19; -116.29; 453.30; 419.57; -212.45 | 0.934 |
| SECONDARY Change in 1-repetition Maximum (1-RM) Leg Press Strength |
62.62; 61.91; 38.18; 64.26; 59.45; 39.36 | 0.946 |
| SECONDARY Change in Total Modified Physical Performance Test (mPPT) Score |
3.32; 2.12; 2.97; 3.33; 2.20; 2.74 | 0.125 |
| SECONDARY Change in Short Physical Performance Battery (SPPB) Score |
1.53; 0.68; 1.45; 1.55; 0.73; 1.43 | 0.006 sig |
| SECONDARY Change in Older Adult Resources and Services (OARS) Activities of Daily Living (ADL) Questionnaire |
0.60; 0.35; 0.79; 0.59; 0.36; 0.83 | 0.326 |
| SECONDARY Change in Functional Status Questionnaire (FSQ) Total Score |
2.04; 1.55; 3.00; 2.02; 1.56; 3.06 | 0.602 |
| SECONDARY Change in Hip Rating Questionnaire Total Score |
8.51; 7.55; 6.01; 8.48; 7.61; 6.01 | 0.649 |
| SECONDARY Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health |
1.89; 1.25; 4.07; 1.88; 1.24; 4.03 | 0.597 |
| SECONDARY Change in Bone Mineral Density (BMD) of the Non-fractured Proximal Femur |
-0.008; -0.001; -0.021; -0.002; 0.001; 0.000 | 0.821 |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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.
- 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) 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 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.
Data sourced from ClinicalTrials.gov (NCT02938923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.