NCT05516849

Placebo Versus Oxandrolone Supplementation in Trauma

Placebo Versus Oxandrolone Supplementation in Trauma: A Randomized Multi-Center Double Blind Clinical Trial in High-Energy Lower Extremity Trauma (POST-Injury Trial)

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lower extremity fractures associated with high-energy mechanisms of injury (combat injuries including blast or crush injuries, motor vehicle accidents, fall from significant height, gunshot injuries) are unfortunately common among active service members and civilians presenting to level-1 trauma centers worldwide. High-energy fractures have several unique characteristics that distinguish them from low-energy injuries. They typically occur in predominately younger, male patients (30-65 years old)1 and involve significant soft-tissue stripping or damage. These patients require at least one major reconstructive surgery, with the majority requiring multiple reconstructive surgeries, each associated with additional soft tissue injury and subsequent prolonged immobilization to facilitate limb stabilization. Despite extended rehabilitation focused on neuromuscular retraining and muscular development, the result is often permanent limitations of ambulation and medical retirement from active duty due to volumetric muscle loss. So, while advances in orthopedic approaches to fracture care have lowered complications such as non-union and malunion, rendering them less significant as limitations to restoring function soft-tissue complications now predominate. Oxandrolone has been successfully utilized to accelerate muscular recovery, reduce muscle loss, and improve function in several populations including healthy elderly patients with frailty/sarcopenia, patients with large surface area burns, neuromuscular diseases, HIV, congenital heart disease and genetic diseases including Klinefelter's and Turner's Syndromes. In addition, Oxandrolone has also been safely used in pediatric patients to treat constitutionally delayed growth. Given the similarities in patient populations and the known limitations of volumetric muscle loss in military personnel and civilians after major trauma, Oxandrolone supplementation may reduce initial volumetric muscle loss and improve long-term muscle mass and function.

Conditions

• Trauma Injury

Interventions

Type	Name	Description
DRUG	Oxandrolone	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.
OTHER	Placebo	As there is currently no approved medication to aid in soft-tissue regeneration, we will be using a placebo control.

Timeline

• Start date: 2022-05-19
• Primary completion: 2023-08-03
• Completion: 2023-08-03
• First posted: 2022-08-26
• Last updated: 2023-08-14

Regulatory

• FDA-regulated drug study