Oxandrolone Multiligament Knee

Phase 4

Suspended

• Conditions: Ligament Tear Knee
• Interventions: Drug: Placebo; Drug: Oxandrolone

• Registration Number: NCT05893069
• Lead Sponsor: George F. Hatch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-30
• Study First Posted: 2023-06-07
• Study Start: 2023-07-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• 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
• Breast cancer
• Hypercalcemia
• Patients with COPD not responsive to bronchodilators
• Patients with known liver disease
• Patients at risk for liver tumors
• Severe hyperlipidemia
• Patients taking medications that interfere with testosterone production or function, including but not limited to 5α-reductase inhibitors, acetaminophen (Tylenol, others), cholesterol lowering

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	Placebo
Treatment group	Oxandrolone	Oxandrolone

Primary Outcome Measures

Name	Time	Method
body fat percentage	Change from baseline at 52 weeksf	measured by bioelectrical impedance analysis
lean body mass	Change from baseline at 52 weeks	measured by bioelectrical impedance analysis

Trial Locations

Locations (1)

Keck School of Medicine of the University of Southern California; 🇺🇸 Los Angeles, California, United States