Oxandrolone Multiligament Knee

NCT05893069 | Suspended Phase 4 FDA Drug

• 1 other identifier: HS-20-00161
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is about healing after a rmultiligament knee reconstruction procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks is effective in aiding in the healing process and restoring muscle mass.

Conditions

Ligament Tear Knee

Keywords

Oxandrolone; Testosterone; Anabolic Steroid

Outcome Measures

Primary Outcomes (2)

• lean body mass

  measured by bioelectrical impedance analysis

  Change from baseline at 52 weeks

• body fat percentage

  measured by bioelectrical impedance analysis

  Change from baseline at 52 weeksf

Study Arms (2)

Treatment group

EXPERIMENTAL

Oxandrolone

Drug: Oxandrolone

Placebo Group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Placebo DRUG

oral placebo for 12 weeks

Placebo Group

Oxandrolone DRUG

oral oxandrolone for 12 weeks

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with MRI proven multiligament knee injury scheduled to undergo multiligament knee reconstruction

You may not qualify if:

• Patients with prior ipsilateral knee surgery
• Untreated diabetes mellitus
• Pituitary tumor
• Rheumatoid Arthritis
• Uncontrolled hypertension
• Congestive Heart Failure
• Myocardial Infarction within the past 6 months
• End-stage renal disease
• Liver enzymes two times the normal value
• DVT within the past 6 months
• Disorder of the coagulation system
• Currently taking anticoagulation
• Prior or current use of anabolic steroids
• Chromosomal disorders
• Prostate cancer

Sponsors & Collaborators

• George F. Hatch: lead

Study Sites (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Interventions

Oxandrolone

Intervention Hierarchy (Ancestors)

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

Study Officials

• George Hatch, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomized
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 7, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)