Clincosm LogoSign in Get a demo

Oxandrolone Multiligament Knee

Sponsor
George F. Hatch (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05893069
Collaborator
(none)
60
Enrollment
2
Arms
31
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Randomized
Primary Purpose:
Supportive Care
Official Title:
Ability of Oral Oxandrolone to Aid in Rehabilitation and Outcomes of Multiligament Knee Reconstructions: A Double-Blind, Randomized Controlled Trial
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group

Oxandrolone

Drug: Oxandrolone
oral oxandrolone for 12 weeks
Placebo Comparator: Placebo Group

Placebo

Drug: Placebo
oral placebo for 12 weeks

Outcome Measures

Primary Outcome Measures

  1. lean body mass [Change from baseline at 52 weeks]

    measured by bioelectrical impedance analysis

  2. body fat percentage [Change from baseline at 52 weeksf]

    measured by bioelectrical impedance analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • George F. Hatch

Investigators

  • Principal Investigator: George Hatch, MD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
George F. Hatch, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier:
NCT05893069
Other Study ID Numbers:
  • HS-20-00161
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 7, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by George F. Hatch, Associate Professor, University of Southern California
Oxandrolone
Testosterone
Anabolic Steroid
Additional relevant MeSH terms:
Oxandrolone

Study Results

No Results Posted as of Jun 7, 2023