Placebo Versus Oxandrolone Supplementation in Trauma

NCT05516849 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: 3822: POST-INJURY
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Trauma Injury

Outcome Measures

Primary Outcomes (1)

• Delta volumetric vastus medialis diameter on MRI

  MRI is taken to assess the vastus medialis muscle mass.

  upto 6 months

Secondary Outcomes (10)

• Delta volumetric thigh muscle mass on MRI

  Up to 1 year

• Functional measure: 6-minute walk test

  Up to 1 year

• Activity count by ActiGraph GT3X-BT

  Up to 1 year

• Short Form 36 Health Survey

  Up to 1 year

• Patient-Reported Outcomes Measurement Information System (PROMIS)

  Up to 1 year

Study Arms (2)

Oxandrolone

EXPERIMENTAL

Participants will be randomly assigned in a 1:1 fashion to one of the two treatment arms using the REDCap database randomization procedure.

Drug: Oxandrolone

Placebo

PLACEBO COMPARATOR

Participants will be randomly assigned in a 1:1 fashion to one of the two treatment arms using the REDCap database randomization procedure.

Other: Placebo

Interventions

Oxandrolone DRUG

Oxandrolone is a synthetic anabolic androgenic steroid that induces its responses by binding to androgen receptors which modulates gene expression to increase protein synthesis and efficient utilisation of amino acids. Oxandrolone was first synthesized in 1962 through 17alpha-alkylation of testosterone resulting in a formal composition of (4bS,7S,9aS,9bR,11aS)-tetradecahydro-7-hydroxy-4aS,6aS,7-trimethyl- cyclopentanaphthopyran-2(1H)-one and molecular formula of C19H30O3.

Oxandrolone

Placebo OTHER

As there is currently no approved medication to aid in soft-tissue regeneration, we will be using a placebo control.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Ages 18-55 \[inclusive\]
• Skeletally-mature as based upon tibial or femoral physeal closure41
• Fracture of the femur or tibia treated with open reduction and internal fixation (simple articular patterns allowed).
• High energy injuries with associated local soft tissue damage. -

You may not qualify if:

• 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.
• Medically unfit for anabolic steroid treatment including those with active malignancy, concurrent prednisone use, elevated liver enzymes at baseline (baseline bloodwork to include LFT)
• Fracture due to primary or metastatic bone lesion
• Any contraindications to MRI.
• 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.
• Patients with substance use disorders, due to increased abuse potential and possible baseline hepatic injury.
• Patients who are on blood thinning medication, at baseline.
• Patients receiving hormone treatment.
• Patients with active cancers.
• Patients with a history of hypercalcemia/parathyroid disease and chronic renal disease.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• United States Department of Defense: collaborator
• Walter Reed National Military Medical Center: collaborator

MeSH Terms

Conditions

Accidental Injuries

Interventions

Oxandrolone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All participants, clinicians, and staff will be blinded to the intervention groups. All patients with an adverse event will be reviewed by an onsite internal medicine affiliated with the study but not directly in recruitment or assessment of outcomes. Emergency unblinding will be allowed if participants present with an adverse event that in the opinion of consulting physicians is not explained by other causes AND knowing the treatment allocation will aid in the patient's management. The blind may be broken only with the permission of the Principal Investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 fashion to one of the two treatment arms using a minimal sufficient randomization technique in REDCAP.

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 26, 2022
• Study Start: May 19, 2022
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share