Placebo Versus Oxandrolone Supplementation in Trauma

• Status: Not yet recruiting
• Trial end date: 2025-02-15
• Target enrollment: 0
• Participant gender: Male

Summary

The primary aim of this study is to examine the effect of Oxandrolone supplementation after lower extremity high energy fracture on muscle volume recovery. As Oxandrolone supplementation has never been examined in this patient population, the primary null hypothesis is that there will be no difference in measured thigh muscle mass volume between Oxandrolone supplementation and placebo administration groups.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: United States Department of Defense; Walter Reed National Military Medical Center
• Treatments: Oxandrolone

Criteria

Inclusion Criteria:

1. Male

2. Ages 18-55 [inclusive]

3. Skeletally-mature as based upon tibial or femoral physeal closure41

4. Fracture of the femur or tibia treated with open reduction and internal fixation (simple articular patterns allowed).

5. High energy injuries with associated local soft tissue damage. -

Exclusion Criteria:

1. Unable to participate in rehabilitation including severe head injury, pre-existing TBI or cognitive dysfunction (stroke, dementia, documented developmental delay), patients with significant spinal cord injury or pre-accident paralytic injury or condition will beessential treatment in both intervention and control groups.

2. Medically unfit for anabolic steroid treatment including those with active malignancy, concurrent prednisone use, elevated liver enzymes at baseline (baseline bloodwork to include LFT)

3. Fracture due to primary or metastatic bone lesion

4. Any contraindications to MRI.

5. Patients with major psychiatric illness [trauma presentation for suicide attempts] and incarcerated patients will be excluded as they may lack autonomy, decision-making capacity and the ability to meet follow-ups.

6. Patients with substance use disorders, due to increased abuse potential and possible baseline hepatic injury.

7. Patients who are on blood thinning medication, at baseline.

8. Patients receiving hormone treatment.

9. Patients with active cancers.

10. Patients with a history of hypercalcemia/parathyroid disease and chronic renal disease.

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