Overview

Starting a Testosterone and Exercise Program After Hip Injury

Status:
Recruiting
Trial end date:
2022-05-31
Target enrollment:
0
Participant gender:
Female
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. Out of nine participants, 4 will receive topical testosterone gel and a supervised exercise training program; 4 will receive topical inactive gel and a supervised exercise training program; and 1 will receive a home exercise program. All participants will receive nutritional counseling, and calcium and vitamin D supplements.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Washington University School of Medicine
Collaborators:
Harvard University
Johns Hopkins University
The University of Texas Medical Branch, Galveston
University of Colorado, Denver
University of Connecticut
University of Maryland
University of Maryland, Baltimore
University of Pittsburgh Medical Center
University of Texas
University of Utah
Treatments:
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
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 <60 ng/dL.

Exclusion Criteria:

- 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.

- 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.