Peri-Operative Testosterone Administration in Primary Total Hip Arthroplasty

NCT06608914 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: AHI-005
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

It is often observed that patients following total hip replacement 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

Osteoarthritis, Hip

Keywords

testosterone; hypogonadism; total hip replacement; total hip arthroplasty

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 (3)

• HOS-SSS

  2 years

• iHOT-12

  2 years

• Total lean body mass

  2 years

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+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• American Hip Institute: lead

Related Publications (13)

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  PMID: 11701431 BACKGROUND

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  PMID: 8637535 BACKGROUND

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  PMID: 12366624 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

• 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

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  PMID: 12028177 BACKGROUND

• 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

MeSH Terms

Conditions

Osteoarthritis, Hip; Hypogonadism

Interventions

Nandrolone Decanoate; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; 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

Benjamin Domb, MD

CONTACT

8338724477; drdomb@americanhipinstitute.org

Alexandra Mantice

CONTACT

8338724477; alexandra.mantice@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: September 20, 2024
• First Posted: September 23, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): November 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