NCT05893069SuspendedPhase 4
Ability of Oral Oxandrolone to Aid in Rehabilitation and Outcomes of Multiligament Knee Reconstructions: A Double-Blind, Randomized Controlled Trial
George F. Hatch1 site in 1 country60 target enrollmentStarted: July 1, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Suspended
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- body fat percentage
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Randomized
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment group
Experimental
Oxandrolone
Intervention: Oxandrolone (Drug)
Placebo Group
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
body fat percentage
Time Frame: Change from baseline at 52 weeksf
measured by bioelectrical impedance analysis
lean body mass
Time Frame: Change from baseline at 52 weeks
measured by bioelectrical impedance analysis
Secondary Outcomes
No secondary outcomes reported
Investigators
George F. Hatch
Associate Professor
University of Southern California
Study Sites (1)
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