What prior FDA approvals exist?

There are no specific FDA approvals for anabolic steroids like Oxandrolone for the treatment of rotator cuff tears. However, treatments for rotator cuff tears generally include physical therapy, corticosteroid injections, and surgical repair. Biologic therapies such as platelet-rich plasma (PRP) injections have been investigated for their potential to enhance healing, but their efficacy remains inconclusive and they are not FDA-approved for this indication. Oxandrolone, being an anabolic steroid, is primarily used for conditions involving severe weight loss and muscle wasting, but its application in rotator cuff repair is still under investigation.

What other types of research exist?

Promising alternatives to Oxandrolone for rotator cuff tear treatment include BPC 157, which promotes tendon-to-bone healing and reduces corticosteroid-induced healing aggravation, and metrenperone, which enhances collagen turnover and remodeling in tendon injuries.

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Oxandrolone for Rotator Cuff Repair (ORCT Trial)

Q: What side effects are associated with this type of intervention?

Anabolic steroids like Oxandrolone, used to aid in muscle mass restoration and healing, can have side effects including liver toxicity, cholesterol alterations, cardiovascular risks, mood swings, and hormonal imbalances. Other common treatments for rotator cuff tears include physical therapy, corticosteroid injections, and surgical repair. Corticosteroid injections may weaken the tendon and increase the risk of rupture, along with potential systemic effects like elevated blood sugar. Surgical repair carries risks of infection, stiffness, and anesthesia-related complications.

N/A

Waitlist Available

Led By George R Hatch, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for rotator cuff repair

Failed nonoperative management of chronic, full thickness rotator cuff tears

Must not have

Myocardial infarction within the past 6 months

End-stage renal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 104 weeks

Summary

This trial is testing if Oxandrolone, a man-made hormone like testosterone, can help patients heal and regain muscle after rotator cuff surgery. The medication is given for a few months to see if it improves muscle recovery. Oxandrolone has been studied for its ability to increase muscle strength and lean body mass in various conditions, including severe burn injuries and muscle wasting in older adults.

Who is the study for?

This trial is for adults with confirmed full thickness rotator cuff tears, scheduled for repair surgery, and who have not improved with non-surgical treatments. It's not suitable for those with recent heart attacks, certain chronic diseases (like untreated diabetes or severe arthritis), a history of specific cancers, pregnant or breastfeeding individuals, or anyone on medications that affect testosterone.

What is being tested?

The study tests if Oxandrolone, a synthetic hormone similar to testosterone, can help heal the rotator cuff after surgery and rebuild muscle mass. Participants will receive either Oxandrolone or a placebo for 12 weeks post-surgery to compare effectiveness in recovery.

What are the potential side effects?

Oxandrolone may cause liver issues, changes in cholesterol levels, increased risk of heart disease, mood swings, hormonal imbalances like altered sex drive or menstrual irregularities and could potentially increase the risk of certain types of cancer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to repair my rotator cuff.

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My shoulder treatment without surgery didn’t work for a complete tear.

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I have a complete tear in my shoulder's rotator cuff, confirmed by MRI.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a heart attack in the last 6 months.

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My kidneys are in the final stage of failure.

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I have a blood clotting disorder.

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I have had shoulder surgery or rotator cuff repair in the past.

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I have severe shoulder arthritis.

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I have been diagnosed with congestive heart failure.

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I am currently on blood thinners.

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I have used anabolic steroids in the past or am currently using them.

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I have a chromosomal disorder.

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I am not taking medications that affect testosterone production or function.

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I have diabetes that has not been treated.

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I have rheumatoid arthritis.

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My high blood pressure is not under control.

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I have a pituitary tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 104 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change in structural integrity of the rotator cuff/tendon healing

Secondary study objectives

change in ASES shoulder score

Other study objectives

change in Body Composition

change in Functional Outcome - Shoulder Strength

change in PASS Score

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment GroupExperimental Treatment1 Intervention

Oxandrolone

Group II: Placebo GroupPlacebo Group1 Intervention

placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxandrolone

2004

Completed Phase 1

~60

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for rotator cuff tears include physical therapy, corticosteroid injections, and surgical repair. Physical therapy focuses on strengthening the surrounding muscles and improving flexibility, which helps support the rotator cuff and reduce pain. Corticosteroid injections reduce inflammation and pain, providing temporary relief to facilitate rehabilitation exercises. Surgical repair involves reattaching the torn tendon to the bone, promoting natural healing. Treatments like Oxandrolone, a synthetic derivative of testosterone, are being studied for their potential to enhance muscle mass restoration and accelerate healing. This is particularly important for rotator cuff tear patients, as improved muscle mass and faster healing can lead to better functional outcomes and a quicker return to daily activities.