Use of Testosterone to Prevent Post-Surgical Muscle Loss - Pilot Study

August 30, 2021 updated by: The Stone Research Foundation for Sports Medicine and Arthritis
The loss of muscle mass post-surgery confounds recovery efforts and leads to a delay in patient's ability to return to activities. Although the use of testosterone in aging and chronic muscle loss has been investigated, this study could prove short-term use of testosterone efficacious in preventing muscle atrophy due to surgery. We hypothesize that by bracketing an indexed knee surgery with testosterone undecanoate injections, post-surgical quadriceps muscle loss may be minimized. Determination of the effect of intra-muscular (IM) testosterone injections in preventing quadriceps muscle loss are measured by serial MRI and manual measurements of quadriceps cross-section.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This is an in vivo study using serial IM testosterone undeconate injections in participants undergoing knee surgery with limited weight bearing post-operatively which includes partial/total knee replacement, ACL reconstruction/revision, meniscal allograft transplantation and articular cartilage paste grafting. The design is a randomized, controlled, double blind, longitudinal study of intra-muscular injections of testosterone versus saline control. Pre-operative and post-operative assessments will include: serial MRIs and manual measurements of quadriceps cross-section and knee pain and function survey, KOOS. Blood analysis will be performed for therapeutic assessment and safety. The participant will receive two testosterone undeconate injections, once during their pre-operative visit and once during their 1 month visit. Timing of assessments will be pre-operative, 1-4 days post-operative and 1, 3, and 6 months. Measurement of the control group versus experimental group at all time points may identify differences in participant response to testosterone injections.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94123
        • Stone Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males age 18-65.
  • Undergoing significant knee surgery such as partial/total knee replacement, ligament reconstruction, meniscus surgeries or articular cartilage paste grafting.

Exclusion Criteria:

  • Men with carcinoma of the breast or known or suspected carcinoma of the prostate.
  • Men with BMI > 30 and Type I or II diabetes diagnosis
  • Men prone to deep vein thrombosis or sleep apnea.
  • Men with pre-existing hematocrit abnormalities.
  • Men with pre-existing cardiac, renal, hepatic disease.
  • Men who are taking insulin, medicines that decrease blood clotting or corticosteroids.
  • Men with known hypersensitivity to testosterone undecanoate or any of its formulation ingredients (testosterone, refined castor oil, benzyl benzoate).
  • Subject's unable or unwilling to comply with the protocol.
  • Subject's unable to provide informed consent.
  • Subject's unable to understand verbal and/or written English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Testosterone Group
Participants receiving two IM Testosterone injections.
Drug: Aveed 750 MG in 3 ML IM Injection
Participants in the Testosterone Group will receive two IM Aveed injections 1 month apart.
PLACEBO_COMPARATOR: Control Group
Participants receiving two IM Normal Saline Injections.
Other: Normal Saline 3 ML IM Injection
Participants in the Control Group will receive two IM normal saline injections 1 month apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MRI Cross Sectional Area of the Quadriceps
Time Frame: Pre-operative and 1, 3, and 6 months post-operative
T1 Axial and Sagittal planes will be obtained using a ONI 1.0T extremity MRI. Axial Cross sectional Area (cm^2) will be measured of the Quadriceps muscle.
Pre-operative and 1, 3, and 6 months post-operative
Change in Manual Measurements of the Quadriceps
Time Frame: Pre-operative and 1, 3, and 6 months post-operative
Manual measurement of the quadriceps muscle will be performed 8-cm proximal to the superior-patella using a standard cm measuring tape.
Pre-operative and 1, 3, and 6 months post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Knee Pain and Function Survey, KOOS
Time Frame: Pre-operative and 1, 3, and 6 months post-operative

Evaluate the knee pain and function of subjects as measures by the KOOS assessment.

Sections:

  1. Pain
  2. Symptoms
  3. Activities of Daily Living
  4. Sports and Recreation
  5. Quality of Life

Scoring:

Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard.
Pre-operative and 1, 3, and 6 months post-operative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum cortisol (mcg/dL) levels
Time Frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Laboratory blood analysis of cortisol will be performed for therapeutic assessment and safety.
Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Change in serum testosterone (ng/dL) levels
Time Frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Laboratory blood analysis of testosterone will be performed for therapeutic assessment and safety.
Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Change in serum prostate specific antigen (ng/mL) levels
Time Frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Laboratory blood analysis of PSA will be performed for therapeutic assessment and safety.
Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Change in serum hepatic function panel (mg/dL) levels
Time Frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Laboratory blood analysis of HFP will be performed for therapeutic assessment and safety.
Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Change in complete blood count with differential levels
Time Frame: Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative
Laboratory blood analysis CBC w/ diff will be performed for therapeutic assessment and safety.
Pre-operative, 1-4 days post-operative and 1 month and 3 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Stone Research Foundation for Sports Medicine and Arthritis

Investigators

  • Study Director: Mani Vessal, Ph.D., Stone Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 8, 2020

Primary Completion (ANTICIPATED)

December 30, 2021

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

June 24, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (ACTUAL)

July 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-030

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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