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Muscle AtrophyPhase 2/3NCT04456530

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

A Phase 2/3 study testing Aveed 750 MG in 3 ML IM Injection and Normal Saline 3 ML IM Injection in people with Muscle Atrophy and Surgery, run by The Stone Research Foundation for Sports Medicine and Arthritis at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
What is being tested?
Aveed 750 MG in 3 ML IM Injection and Normal Saline 3 ML IM Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteUnited States
Study dates
8 May 2020to 30 Jun 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stone Research Foundation

    San Francisco, California, 94123

Other trials in United States

About this study

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.

Read the 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.

Being tested
Aveed 750 MG in 3 ML IM Injection, Normal Saline 3 ML IM Injection
Keywords
Surgery, Testosterone, Muscle atrophy, Post-operative rehabilitation
Medical subject headings
Muscular Atrophy, Knee Injuries, Disease, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aveed 750 MG in 3 ML IM InjectionDrug

    Participants in the Testosterone Group will receive two IM Aveed injections 1 month apart.

  • Normal Saline 3 ML IM InjectionOther

    Participants in the Control Group will receive two IM normal saline injections 1 month apart.

Study groups in NCT04456530
Study groupRoleWhat they receive
Testosterone GroupExperimentalParticipants receiving two IM Testosterone injections.
Receives: Drug: Aveed 750 MG in 3 ML IM Injection
Control GroupPlacebo comparatorParticipants receiving two IM Normal Saline Injections.
Receives: Other: Normal Saline 3 ML IM Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in MRI Cross Sectional Area of the Quadriceps

    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.

    Measured: Pre-operative and 1, 3, and 6 months post-operative

  2. Change in Manual Measurements of the Quadriceps

    Manual measurement of the quadriceps muscle will be performed 8-cm proximal to the superior-patella using a standard cm measuring tape.

    Measured: Pre-operative and 1, 3, and 6 months post-operative

Secondary outcomes (1)

  1. Change in Knee Pain and Function Survey, KOOS

    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.

    Measured: Pre-operative and 1, 3, and 6 months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2020
  2. Study start8 May 2020
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04456530
Sponsor's protocol ID
SRF-030
Status last verified
Aug 2021
First submitted
24 Jun 2020
Last updated
31 Aug 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Bassil N, Alkaade S, Morley JE. The benefits and risks of testosterone replacement therapy: a review. Ther Clin Risk Manag. 2009 Jun;5(3):427-48. doi: 10.2147/tcrm.s3025. Epub 2009 Jun 22.

    PubMed 19707253

  • Nicholas JJ, Taylor FH, Buckingham RB, Ottonello D. Measurement of circumference of the knee with ordinary tape measure. Ann Rheum Dis. 1976 Jun;35(3):282-4. doi: 10.1136/ard.35.3.282.

    PubMed 984911

  • Arangio GA, Chen C, Kalady M, Reed JF 3rd. Thigh muscle size and strength after anterior cruciate ligament reconstruction and rehabilitation. J Orthop Sports Phys Ther. 1997 Nov;26(5):238-43. doi: 10.2519/jospt.1997.26.5.238.

    PubMed 9353686

  • Marcon M, Ciritsis B, Laux C, Nanz D, Nguyen-Kim TD, Fischer MA, Andreisek G, Ulbrich EJ. Cross-sectional area measurements versus volumetric assessment of the quadriceps femoris muscle in patients with anterior cruciate ligament reconstructions. Eur Radiol. 2015 Feb;25(2):290-8. doi: 10.1007/s00330-014-3424-2. Epub 2014 Oct 31.

    PubMed 25358592

  • Ruhdorfer AS, Dannhauer T, Wirth W, Cotofana S, Roemer F, Nevitt M, Eckstein F; OAI investigators. Thigh muscle cross-sectional areas and strength in knees with early vs knees without radiographic knee osteoarthritis: a between-knee, within-person comparison. Osteoarthritis Cartilage. 2014 Oct;22(10):1634-8. doi: 10.1016/j.joca.2014.06.002.

    PubMed 25278072

  • Orgiu S, Lafortuna CL, Rastelli F, Cadioli M, Falini A, Rizzo G. Automatic muscle and fat segmentation in the thigh from T1-Weighted MRI. J Magn Reson Imaging. 2016 Mar;43(3):601-10. doi: 10.1002/jmri.25031. Epub 2015 Aug 13.

    PubMed 26268693

  • Hartgens F, Kuipers H. Effects of androgenic-anabolic steroids in athletes. Sports Med. 2004;34(8):513-54. doi: 10.2165/00007256-200434080-00003.

    PubMed 15248788

  • Irrgang JJ, Ho H, Harner CD, Fu FH. Use of the International Knee Documentation Committee guidelines to assess outcome following anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 1998;6(2):107-14. doi: 10.1007/s001670050082.

    PubMed 9604196

  • Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160.

    PubMed 1285753

  • Amory JK, Chansky HA, Chansky KL, Camuso MR, Hoey CT, Anawalt BD, Matsumoto AM, Bremner WJ. Preoperative supraphysiological testosterone in older men undergoing knee replacement surgery. J Am Geriatr Soc. 2002 Oct;50(10):1698-701. doi: 10.1046/j.1532-5415.2002.50462.x.

    PubMed 12366624

  • Griggs RC, Kingston W, Jozefowicz RF, Herr BE, Forbes G, Halliday D. Effect of testosterone on muscle mass and muscle protein synthesis. J Appl Physiol (1985). 1989 Jan;66(1):498-503. doi: 10.1152/jappl.1989.66.1.498.

    PubMed 2917954

  • Akima H, Furukawa T. Atrophy of thigh muscles after meniscal lesions and arthroscopic partial menisectomy. Knee Surg Sports Traumatol Arthrosc. 2005 Nov;13(8):632-7. doi: 10.1007/s00167-004-0602-9. Epub 2005 Apr 13.

    PubMed 15827765

  • Wu B, Lorezanza D, Badash I, Berger M, Lane C, Sum JC, Hatch GF 3rd, Schroeder ET. Perioperative Testosterone Supplementation Increases Lean Mass in Healthy Men Undergoing Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2017 Aug 9;5(8):2325967117722794. doi: 10.1177/2325967117722794. eCollection 2017 Aug.

    PubMed 28840147

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Aveed 750 MG in 3 ML IM Injection and Normal Saline 3 ML IM Injection in people with Muscle Atrophy and Surgery, run by The Stone Research Foundation for Sports Medicine and Arthritis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in MRI Cross Sectional Area of the Quadriceps (time frame: Pre-operative and 1, 3, and 6 months post-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04456530, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.

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