Peri-Operative Testosterone Administration in Primary Hip Arthroscopy

NCT06462482 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: AHI-004
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is often observed that patients following hip surgery have a hard time with rehabilitation, as patients commonly lose muscle mass and strength around the surgical site. The goal of this study is to learn if giving patients testosterone around their hip surgery can prevent them from losing muscle mass, as well as to see if it will improve their outcomes after surgery. The main question this study aims to answer is: Will perioperative testosterone administration increase lean mass in addition to improving functional and clinical patient reported outcomes greater than placebo? Researchers will compare patients who were administered testosterone to standard of care (no administration of testosterone) to see if there is a difference in their recovery and outcomes. Participants will be given either testosterone or saline for eight weeks beginning two weeks prior to surgery. Participants will have to answer questionnaires on how they are doing, as well as will do other testing during this time.

Conditions

Femoro Acetabular Impingement

Keywords

Testosterone; Hypogonadism; Hip arthroscopy

Outcome Measures

Primary Outcomes (1)

• modified Harris Hip Score

  Patient-reported outcome measure. Scale 0-100, 100 indicating optimal function outcome

  2 years

Secondary Outcomes (7)

• Total lean body mass

  2 years

• Nonarthritic Hip Score

  2 years

• HOS-SSS

  2 years

• iHOT-12

  2 years

• Age

  Before surgery

Study Arms (2)

Testosterone Arm

EXPERIMENTAL

The testosterone group will receive a 200mg dose of intramuscular testosterone cypionate (also known as Nandrolone) weekly for 8 weeks beginning 2 weeks prior to surgery.

Drug: Nandrolone Decanoate

Saline Arm

PLACEBO COMPARATOR

The saline group will receive a 200mg dose of intramuscular saline weekly for 8 weeks beginning 2 weeks prior to surgery.

Drug: Saline

Interventions

Nandrolone Decanoate DRUG

Nandrolone will be administered to the testosterone group, specifically a 200mg dose weekly for 8 weeks beginning 2 weeks prior to surgery.

Testosterone Arm

Saline DRUG

Saline will be administered to the saline group, specifically a 200mg dose weekly for 8 weeks beginning 2 weeks prior to surgery.

Saline Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• American Hip Institute: lead

Related Publications (14)

• Beck EC, Nwachukwu BU, Krivicich LM, Malloy P, Suppauksorn S, Jan K, Nho SJ. Preoperative Hip Extension Strength Is an Independent Predictor of Achieving Clinically Significant Outcomes After Hip Arthroscopy for Femoroacetabular Impingement Syndrome. Sports Health. 2020 Jul/Aug;12(4):361-372. doi: 10.1177/1941738120910134. Epub 2020 May 11.

  PMID: 32392094 BACKGROUND

• Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.

  PMID: 12028177 BACKGROUND

• Chen F, Lam R, Shaywitz D, Hendrickson RC, Opiteck GJ, Wishengrad D, Liaw A, Song Q, Stewart AJ, Cummings CE, Beals C, Yarasheski KE, Reicin A, Ruddy M, Hu X, Yates NA, Menetski J, Herman GA. Evaluation of early biomarkers of muscle anabolic response to testosterone. J Cachexia Sarcopenia Muscle. 2011 Mar;2(1):45-56. doi: 10.1007/s13539-011-0021-y. Epub 2011 Feb 26.

  PMID: 21475673 BACKGROUND

• Serra C, Bhasin S, Tangherlini F, Barton ER, Ganno M, Zhang A, Shansky J, Vandenburgh HH, Travison TG, Jasuja R, Morris C. The role of GH and IGF-I in mediating anabolic effects of testosterone on androgen-responsive muscle. Endocrinology. 2011 Jan;152(1):193-206. doi: 10.1210/en.2010-0802. Epub 2010 Nov 17.

  PMID: 21084444 BACKGROUND

• White JP, Baltgalvis KA, Sato S, Wilson LB, Carson JA. Effect of nandrolone decanoate administration on recovery from bupivacaine-induced muscle injury. J Appl Physiol (1985). 2009 Nov;107(5):1420-30. doi: 10.1152/japplphysiol.00668.2009. Epub 2009 Sep 10.

  PMID: 19745189 BACKGROUND

• 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.

  PMID: 28840147 BACKGROUND

• 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.

  PMID: 12366624 BACKGROUND

• Bhasin S, Storer TW, Berman N, Callegari C, Clevenger B, Phillips J, Bunnell TJ, Tricker R, Shirazi A, Casaburi R. The effects of supraphysiologic doses of testosterone on muscle size and strength in normal men. N Engl J Med. 1996 Jul 4;335(1):1-7. doi: 10.1056/NEJM199607043350101.

  PMID: 8637535 BACKGROUND

• Sattler FR, Castaneda-Sceppa C, Binder EF, Schroeder ET, Wang Y, Bhasin S, Kawakubo M, Stewart Y, Yarasheski KE, Ulloor J, Colletti P, Roubenoff R, Azen SP. Testosterone and growth hormone improve body composition and muscle performance in older men. J Clin Endocrinol Metab. 2009 Jun;94(6):1991-2001. doi: 10.1210/jc.2008-2338. Epub 2009 Mar 17.

  PMID: 19293261 BACKGROUND

• Basaria S, Coviello AD, Travison TG, Storer TW, Farwell WR, Jette AM, Eder R, Tennstedt S, Ulloor J, Zhang A, Choong K, Lakshman KM, Mazer NA, Miciek R, Krasnoff J, Elmi A, Knapp PE, Brooks B, Appleman E, Aggarwal S, Bhasin G, Hede-Brierley L, Bhatia A, Collins L, LeBrasseur N, Fiore LD, Bhasin S. Adverse events associated with testosterone administration. N Engl J Med. 2010 Jul 8;363(2):109-22. doi: 10.1056/NEJMoa1000485. Epub 2010 Jun 30.

  PMID: 20592293 BACKGROUND

• Basaria S, Wahlstrom JT, Dobs AS. Clinical review 138: Anabolic-androgenic steroid therapy in the treatment of chronic diseases. J Clin Endocrinol Metab. 2001 Nov;86(11):5108-17. doi: 10.1210/jcem.86.11.7983.

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• Bhasin S, Storer TW, Javanbakht M, Berman N, Yarasheski KE, Phillips J, Dike M, Sinha-Hikim I, Shen R, Hays RD, Beall G. Testosterone replacement and resistance exercise in HIV-infected men with weight loss and low testosterone levels. JAMA. 2000 Feb 9;283(6):763-70. doi: 10.1001/jama.283.6.763.

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• Bhasin S, Woodhouse L, Casaburi R, Singh AB, Bhasin D, Berman N, Chen X, Yarasheski KE, Magliano L, Dzekov C, Dzekov J, Bross R, Phillips J, Sinha-Hikim I, Shen R, Storer TW. Testosterone dose-response relationships in healthy young men. Am J Physiol Endocrinol Metab. 2001 Dec;281(6):E1172-81. doi: 10.1152/ajpendo.2001.281.6.E1172.

  PMID: 11701431 BACKGROUND

• Rothney MP, Martin FP, Xia Y, Beaumont M, Davis C, Ergun D, Fay L, Ginty F, Kochhar S, Wacker W, Rezzi S. Precision of GE Lunar iDXA for the measurement of total and regional body composition in nonobese adults. J Clin Densitom. 2012 Oct-Dec;15(4):399-404. doi: 10.1016/j.jocd.2012.02.009. Epub 2012 Apr 26.

  PMID: 22542222 BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement; Hypogonadism

Interventions

Nandrolone Decanoate; Sodium Chloride

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nandrolone; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Alexandra Mantice

CONTACT

8338724477; alexandra.mantice@americanhipinstitute.org

Benjamin Domb, MD

CONTACT

8338724477; drdomb@americanhipinstitute.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share