Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)

NCT07036003 | Recruiting Phase 1 DMC

• 1 other identifier: 6427
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to see if people with knee osteoarthritis would be willing to comply and adhere to incorporating Recombinant Human Growth Hormone (rHGH), specifically Saizen Somatropin solution, into their treatment plan. Participants will be asked to:

• Self-inject the treatment solution (placebo or somatropin) into the abdominal or gluteal area once per day for a total of 6 weeks.
• Complete questionnaires related to their knee pain and activities of daily living.
• Provide blood tests.
• Complete various measurements including: circumference of thigh, calf, and abdomen; strength of thigh and knee; range of motion of both knees; and gait analysis.

Conditions

Knee Osteoarthritis (Knee OA); Knee Osteoarthritis (OA)

Keywords

Recombinant Human Growth Hormone; rHGH; Saizen; Knee Osteoarthritis; Knee OA

Outcome Measures

Primary Outcomes (1)

• Feasibility of the medication administration

  Participant adheres to self-administration of injections once daily for 6 weeks.

  6 weeks after treatment begins.

Secondary Outcomes (13)

• Clinical Outcomes: knee extension strength

  At 6 weeks and 24 months time points after enrolment

• Clinical Outcome: knee flexion strength

  At 24 months after enrolment.

• Clinical Outcomes: thigh muscle strength

  At baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months study visits.

• Clinical Outcomes: Kinematic Gait Analysis

  At baseline, 6 weeks and 6 months study visits.

• Thigh circumference

  At baseline, 6 weeks, 3, 6, 12 and 24 months study visits

Study Arms (2)

Recombinant Human Growth Hormone (rHGH)

EXPERIMENTAL

Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.

Drug: Somatropin (recombinant human growth hormone)

Bacteriostatic Saline

PLACEBO COMPARATOR

Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.

Drug: bacteriostatic saline placebo

Interventions

bacteriostatic saline placebo DRUG

Study participants will deliver bacteriostatic saline via self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks in an identical delivery device to the experimental arm.

Bacteriostatic Saline

Somatropin (recombinant human growth hormone) DRUG

Study participants will deliver Somatropin via self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks at a dose of 0.5mg/day per body surface area (0.5mg/m2/day).

Recombinant Human Growth Hormone (rHGH)

Eligibility Criteria

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

You may qualify if:

• Between 18 - 65 years old.
• Diagnosis of isolated knee osteoarthritis for greater than 6 months.

You may not qualify if:

• Previous or pending major intra-articular or reconstructive surgery to the involved knee, including femoral/tibial osteotomies, ligament repair/reconstruction, or cartilage transplantation. Patients with remote (\>1 year) diagnostic arthroscopy, arthroscopic debridement, meniscectomy, or meniscal repair may be allowed to participate at the investigators' discretion.
• Previous major trauma (including fracture, dislocation, open injury) to the involved knee, or ipsilateral hip, knee, ankle, or hip. Patients with prior complete ligament tears will be excluded, patients with chronic partial thickness ligament tears or degenerative/complex meniscal tears (\>6 months from injury) may be included at the investigators' discretion
• Recent (less than 6 months) intra-articular injection into the involved knee.
• High grade ligamentous knee injury.
• Known allergy to recombinant human growth hormone (rHGH) or reconstitutive solutions.
• BMI of less than 20 or greater than 35.
• Documented history of growth disorder of bones or connective tissue, type 1 or 2 diabetes, myopathy, cancer, endocrine disorder, severe hypertension (SBP \> 180) or rheumatologic disorder.
• Pregnant or breastfeeding, or actively attempting to get pregnant.
• Currently on hypoglycemic therapy, oral estrogen or glucocorticoid replacement therapy.
• Would have difficulty with the self-injection schedule or other cognitive/ functional limitations.
• Have taken creatine within 7 days before baseline. Potential participants will be given the option to pause their supplements and then re-screen if they are interested in the study,
• Have taken anabolic steroids within 42 days (6 weeks) before baseline. Potential participants will be given the option to pause their supplements and then rescreen if they are interested in the study,
• Vital signs or routine bloodwork outside of normal range.

Sponsors & Collaborators

• Dr. David Wasserstein: lead
• Sunnybrook Research Institute: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Related Publications (36)

• Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes. 2003 Nov 3;1:64. doi: 10.1186/1477-7525-1-64.

  PMID: 14613558 BACKGROUND

• Barake M, Klibanski A, Tritos NA. Effects of recombinant human growth hormone therapy on bone mineral density in adults with growth hormone deficiency: a meta-analysis. J Clin Endocrinol Metab. 2014 Mar;99(3):852-60. doi: 10.1210/jc.2013-3921. Epub 2014 Jan 1.

  PMID: 24423364 BACKGROUND

• Yeo AL, Levy D, Martin FC, Sonksen P, Sturgess I, Wheeler MM, Young A. Frailty and the biochemical effects of recombinant human growth hormone in women after surgery for hip fracture. Growth Horm IGF Res. 2003 Dec;13(6):361-70. doi: 10.1016/j.ghir.2003.08.001.

  PMID: 14624771 BACKGROUND

• Tavares AB, Micmacher E, Biesek S, Assumpcao R, Redorat R, Veloso U, Vaisman M, Farinatti PT, Conceicao F. Effects of Growth Hormone Administration on Muscle Strength in Men over 50 Years Old. Int J Endocrinol. 2013;2013:942030. doi: 10.1155/2013/942030. Epub 2013 Dec 8.

  PMID: 24382963 BACKGROUND

• Rahimzadeh P, Imani F, Faiz SH, Alebouyeh MR, Azad-Ehyaei D, Bahari L, Memarian A, Kim KH. Adding Intra-Articular Growth Hormone to Platelet Rich Plasma under Ultrasound Guidance in Knee Osteoarthritis: A Comparative Double-Blind Clinical Trial. Anesth Pain Med. 2016 Oct 19;6(6):e41719. doi: 10.5812/aapm.41719. eCollection 2016 Dec.

  PMID: 28975078 BACKGROUND

• Dunn AR. Intra-articular growth hormone injections regrow cartilage, increase motion and reduce pain in 93 per cent. of arthritic ankles. Osteoarthritis Cartilage. 2012;20:S295-S296. doi:10.1016/j.joca.2012.02.512

  BACKGROUND

• Yang S, Cao L, Cai S, Yuan J, Wang J. A systematic review of growth hormone for hip fractures. Growth Horm IGF Res. 2012 Jun-Aug;22(3-4):97-101. doi: 10.1016/j.ghir.2012.03.002. Epub 2012 Apr 1.

  PMID: 22472350 BACKGROUND

• Yarasheski KE, Campbell JA, Smith K, Rennie MJ, Holloszy JO, Bier DM. Effect of growth hormone and resistance exercise on muscle growth in young men. Am J Physiol. 1992 Mar;262(3 Pt 1):E261-7. doi: 10.1152/ajpendo.1992.262.3.E261.

  PMID: 1550219 BACKGROUND

• Dubiel R, Callender L, Dunklin C, Harper C, Bennett M, Kreber L, Auchus R, Diaz-Arrastia R. Phase 2 Randomized, Placebo-Controlled Clinical Trial of Recombinant Human Growth Hormone (rhGH) During Rehabilitation From Traumatic Brain Injury. Front Endocrinol (Lausanne). 2018 Sep 10;9:520. doi: 10.3389/fendo.2018.00520. eCollection 2018.

  PMID: 30250451 BACKGROUND

• Abreu ME, Valiati R, Hubler R, Moraes AN, Antonini F, de Oliveira Hdo C, Pagnoncelli RM. Effect of Recombinant Human Growth Hormone on Osseointegration of Titanium Implants: A Histologic and Biomechanical Study in Rabbits. J Oral Implantol. 2015 Aug;41(4):e102-9. doi: 10.1563/aaid-joi-D-13-00306. Epub 2014 Jun 19.

  PMID: 24946138 BACKGROUND

• Ehrnberg A, Brosjo O, Laftman P, Nilsson O, Stromberg L. Enhancement of bone formation in rabbits by recombinant human growth hormone. Acta Orthop Scand. 1993 Oct;64(5):562-6. doi: 10.3109/17453679308993693.

  PMID: 8237325 BACKGROUND

• Raschke MJ, Bail H, Windhagen HJ, Kolbeck SF, Weiler A, Raun K, Kappelgard A, Skiaerbaek C, Haas NP. Recombinant growth hormone accelerates bone regenerate consolidation in distraction osteogenesis. Bone. 1999 Feb;24(2):81-8. doi: 10.1016/s8756-3282(98)00158-6.

  PMID: 9951774 BACKGROUND

• Kim SB, Kwon DR, Kwak H, Shin YB, Han HJ, Lee JH, Choi SH. Additive effects of intra-articular injection of growth hormone and hyaluronic acid in rabbit model of collagenase-induced osteoarthritis. J Korean Med Sci. 2010 May;25(5):776-80. doi: 10.3346/jkms.2010.25.5.776. Epub 2010 Apr 16.

  PMID: 20436717 BACKGROUND

• Hao Y, Dai K, Guo L, Wang Y, Tang T. Effects of recombinant human growth hormone (r-hGH) on experimental osteoporotic fracture healing. Chin J Traumatol. 2001 May;4(2):102-5.

  PMID: 11834155 BACKGROUND

• Lubis AMT, Wijaya MT, Priosoeryanto BP, Saleh RF, Farqani S. Comparison of weekly and single dose intraarticular recombinant human growth hormone injection on cartilage degeneration in osteoarthritic model of white New Zealand rabbits. J Exp Orthop. 2022 Feb 21;9(1):19. doi: 10.1186/s40634-022-00458-y. No abstract available.

  PMID: 35190919 BACKGROUND

• Lubis AMT, Wonggokusuma E, Marsetio AF. Intra-articular Recombinant Human Growth Hormone Injection Compared with Hyaluronic Acid and Placebo for an Osteoarthritis Model of New Zealand Rabbits. Knee Surg Relat Res. 2019 Mar 1;31(1):44-53. doi: 10.5792/ksrr.18.062.

  PMID: 30871292 BACKGROUND

• Boesen AP, Dideriksen K, Couppe C, Magnusson SP, Schjerling P, Boesen M, Kjaer M, Langberg H. Tendon and skeletal muscle matrix gene expression and functional responses to immobilisation and rehabilitation in young males: effect of growth hormone administration. J Physiol. 2013 Dec 1;591(23):6039-52. doi: 10.1113/jphysiol.2013.261263. Epub 2013 Sep 30.

  PMID: 24081158 BACKGROUND

• Linderman JK, Gosselink KL, Booth FW, Mukku VR, Grindeland RE. Resistance exercise and growth hormone as countermeasures for skeletal muscle atrophy in hindlimb-suspended rats. Am J Physiol. 1994 Aug;267(2 Pt 2):R365-71. doi: 10.1152/ajpregu.1994.267.2.R365.

  PMID: 8067444 BACKGROUND

• Dalla Libera L, Ravara B, Volterrani M, Gobbo V, Della Barbera M, Angelini A, Danieli Betto D, Germinario E, Vescovo G. Beneficial effects of GH/IGF-1 on skeletal muscle atrophy and function in experimental heart failure. Am J Physiol Cell Physiol. 2004 Jan;286(1):C138-44. doi: 10.1152/ajpcell.00114.2003. Epub 2003 Sep 17.

  PMID: 13679302 BACKGROUND

• Newman CB, Carmichael JD, Kleinberg DL. Effects of low dose versus high dose human growth hormone on body composition and lipids in adults with GH deficiency: a meta-analysis of placebo-controlled randomized trials. Pituitary. 2015 Jun;18(3):297-305. doi: 10.1007/s11102-014-0571-z.

  PMID: 24810900 BACKGROUND

• Vinciguerra M, Musaro A, Rosenthal N. Regulation of muscle atrophy in aging and disease. Adv Exp Med Biol. 2010;694:211-33. doi: 10.1007/978-1-4419-7002-2_15.

  PMID: 20886766 BACKGROUND

• Favier FB, Benoit H, Freyssenet D. Cellular and molecular events controlling skeletal muscle mass in response to altered use. Pflugers Arch. 2008 Jun;456(3):587-600. doi: 10.1007/s00424-007-0423-z. Epub 2008 Jan 12.

  PMID: 18193272 BACKGROUND

• Al-Samerria S, Radovick S. The Role of Insulin-like Growth Factor-1 (IGF-1) in the Control of Neuroendocrine Regulation of Growth. Cells. 2021 Oct 5;10(10):2664. doi: 10.3390/cells10102664.

  PMID: 34685644 BACKGROUND

• Brinkman JE, Tariq MA, Leavitt L, Sharma S. Physiology, Growth Hormone. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482141/

  PMID: 29489209 BACKGROUND

• Hoglund LT, Pontiggia L, Kelly JD 4th. A 6-week hip muscle strengthening and lumbopelvic-hip core stabilization program to improve pain, function, and quality of life in persons with patellofemoral osteoarthritis: a feasibility pilot study. Pilot Feasibility Stud. 2018 Apr 6;4:70. doi: 10.1186/s40814-018-0262-z. eCollection 2018.

  PMID: 29636983 BACKGROUND

• Brosseau L, Taki J, Desjardins B, Thevenot O, Fransen M, Wells GA, Mizusaki Imoto A, Toupin-April K, Westby M, Alvarez Gallardo IC, Gifford W, Laferriere L, Rahman P, Loew L, De Angelis G, Cavallo S, Shallwani SM, Aburub A, Bennell KL, Van der Esch M, Simic M, McConnell S, Harmer A, Kenny GP, Paterson G, Regnaux JP, Lefevre-Colau MM, McLean L. The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part two: strengthening exercise programs. Clin Rehabil. 2017 May;31(5):596-611. doi: 10.1177/0269215517691084. Epub 2017 Feb 1.

  PMID: 28183213 BACKGROUND

• Brosseau L, Taki J, Desjardins B, Thevenot O, Fransen M, Wells GA, Mizusaki Imoto A, Toupin-April K, Westby M, Alvarez Gallardo IC, Gifford W, Laferriere L, Rahman P, Loew L, De Angelis G, Cavallo S, Shallwani SM, Aburub A, Bennell KL, Van der Esch M, Simic M, McConnell S, Harmer A, Kenny GP, Paterson G, Regnaux JP, Lefevre-Colau MM, McLean L. The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part three: aerobic exercise programs. Clin Rehabil. 2017 May;31(5):612-624. doi: 10.1177/0269215517691085. Epub 2017 Feb 9.

  PMID: 28183194 BACKGROUND

• Brosseau L, Taki J, McLean L. The Ottawa panel clinical practice guidelines for the management of knee osteoarthritis. Part one: introduction, and mind-body exercise programs. Accessed October 15, 2024. https://journals-sagepub- com.myaccess.library.utoronto.ca/doi/10.1177/0269215517691083?icid=int.sj-full- text.similar-articles.2

  BACKGROUND

• Segal NA, Glass NA, Felson DT, Hurley M, Yang M, Nevitt M, Lewis CE, Torner JC. Effect of quadriceps strength and proprioception on risk for knee osteoarthritis. Med Sci Sports Exerc. 2010 Nov;42(11):2081-8. doi: 10.1249/MSS.0b013e3181dd902e.

  PMID: 20351594 BACKGROUND

• Lewek MD, Rudolph KS, Snyder-Mackler L. Quadriceps femoris muscle weakness and activation failure in patients with symptomatic knee osteoarthritis. J Orthop Res. 2004 Jan;22(1):110-5. doi: 10.1016/S0736-0266(03)00154-2.

  PMID: 14656668 BACKGROUND

• Amoako AO, Pujalte GG. Osteoarthritis in young, active, and athletic individuals. Clin Med Insights Arthritis Musculoskelet Disord. 2014 May 22;7:27-32. doi: 10.4137/CMAMD.S14386. eCollection 2014.

  PMID: 24899825 BACKGROUND

• Khan M, Adili A, Winemaker M, Bhandari M. Management of osteoarthritis of the knee in younger patients. CMAJ. 2018 Jan 22;190(3):E72-E79. doi: 10.1503/cmaj.170696. No abstract available.

  PMID: 29358201 BACKGROUND

• Li CS, Karlsson J, Winemaker M, Sancheti P, Bhandari M. Orthopedic surgeons feel that there is a treatment gap in management of early OA: international survey. Knee Surg Sports Traumatol Arthrosc. 2014 Feb;22(2):363-78. doi: 10.1007/s00167-013-2529-5. Epub 2013 Jun 18.

  PMID: 23775341 BACKGROUND

• Mendias CL, Enselman ERS, Olszewski AM, Gumucio JP, Edon DL, Konnaris MA, Carpenter JE, Awan TM, Jacobson JA, Gagnier JJ, Barkan AL, Bedi A. The Use of Recombinant Human Growth Hormone to Protect Against Muscle Weakness in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Pilot, Randomized Placebo-Controlled Trial. Am J Sports Med. 2020 Jul;48(8):1916-1928. doi: 10.1177/0363546520920591. Epub 2020 May 26.

  PMID: 32452208 BACKGROUND

• Brophy RH, Fillingham YA. AAOS Clinical Practice Guideline Summary: Management of Osteoarthritis of the Knee (Nonarthroplasty), Third Edition. J Am Acad Orthop Surg. 2022 May 1;30(9):e721-e729. doi: 10.5435/JAAOS-D-21-01233.

  PMID: 35383651 BACKGROUND

• Shah A, Ravi B, Tomescu S, Catapano M, Burkhart TA, Whyne C, Kiss A, Marks P, Wasserstein DN. Recombinant human growth hormone (rHGH) for muscle enhancement in knee osteoarthritis: protocol for a pilot, randomised placebo-controlled trial. BMJ Open. 2026 Feb 4;16(2):e106999. doi: 10.1136/bmjopen-2025-106999.

  PMID: 41638751 DERIVED

Related Links

• Saizen Drug Monograph. Accessed October 15, 2024.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Human Growth Hormone; Growth Hormone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dr. David Wasserstein

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. David Wasserstein

CONTACT

416-480-5798; david.wasserstein@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor - University of Toronto; Associate Scientist - Sunnybrook Research Institute

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 25, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal will be able to access the IPD and supporting information to achieve aims in the approved proposal. Proposals should be directed to david.wasserstein@sunnybrook.ca. To gain access, data requestors will need to sign a data access agreement.

Locations

CA (1)