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

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.

Timeline

Start

2025-10-31

Primary completion

2028-07

Completion

2029-01

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Background Linderman JK, Gosselink KL, Booth FW, Mukku VR, Grindeland RE; New Collective Author. 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Background Brinkman JE, Tariq MA, Leavitt L, Sharma S. Physiology, Growth Hormone(Archived). 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482141/
• 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.
• 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.
• 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.
• Background Brosseau L, Taki J, Desjardins B, Thevenot O, Fransen M, Wells GA, Imoto AM, Toupin-April K, Westby M, Gallardo ICA, Gifford W, Laferriere L, Rahman P, Loew L, 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 one: introduction, and mind-body exercise programs. Clin Rehabil. 2017 May;31(5):582-595. doi: 10.1177/0269215517691083. Epub 2017 Feb 9.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications