Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 8:53 AM
Study NCT ID:
NCT07036003
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2025-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019382', 'term': 'Human Growth Hormone'}, {'id': 'D013006', 'term': 'Growth Hormone'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2025-05-30', 'studyFirstSubmitQcDate': '2025-06-16', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the medication administration', 'timeFrame': '6 weeks after treatment begins.', 'description': 'Participant adheres to self-administration of injections once daily for 6 weeks.'}], 'secondaryOutcomes': [{'measure': 'Clinical Outcomes: knee extension strength', 'timeFrame': 'At 6 weeks and 24 months time points after enrolment', 'description': "Participants' knee extension strength will be measured using HUMAC Norm Extremity Strength Testing system."}, {'measure': 'Clinical Outcome: knee flexion strength', 'timeFrame': 'At 24 months after enrolment.', 'description': "Participants' knee flexion strength will be measured using HUMAC Norm Extremity Strength Testing system."}, {'measure': 'Clinical Outcomes: thigh muscle strength', 'timeFrame': 'At baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months study visits.', 'description': "Participants' thigh muscle strength will be measured through hip flexion, hip abduction and knee flexion using a goniometer."}, {'measure': 'Clinical Outcomes: Kinematic Gait Analysis', 'timeFrame': 'At baseline, 6 weeks and 6 months study visits.', 'description': "Participants' kinematic gait analysis will be measured with single/ two leg hop/jump and single/ two leg squat, using the Theia Markerless system before and after treatment."}, {'measure': 'Thigh circumference', 'timeFrame': 'At baseline, 6 weeks, 3, 6, 12 and 24 months study visits', 'description': "Participant's measurements of function will be measured by their thigh circumference compared to the contralateral leg, and baseline."}, {'measure': 'Mid-calf circumference', 'timeFrame': 'At baseline, 6 weeks, 3, 6, 12 and 24 months study visits', 'description': "Participant's measurements of function will be measured by their mid-calf circumference compared to the contralateral leg, and baseline."}, {'measure': 'Abdominal circumference', 'timeFrame': 'At baseline, 6 weeks, 3, 6, 12 and 24 months study visits', 'description': "Participant's measurements of function will be measured by their abdominal circumference."}, {'measure': 'Range of motion of both knees', 'timeFrame': 'At baseline, 6 weeks, 3, 6, 12 and 24 months study visits', 'description': "Participant's measurements of function will be measured by Range of motion of both knees."}, {'measure': '6 Minute Walk Test (6MWT)', 'timeFrame': 'At baseline, 6 weeks, 3 months, 6 months, and 12 months after enrolment.', 'description': "Participants' distance traveled in the span of 6 minutes will be measured on a treadmill (unit: total meters)."}, {'measure': 'Activity Count', 'timeFrame': 'From enrolment to the 12-week study visit.', 'description': "Participants' activity count will be measured using a fitness tracker (ActiGraph) worn around the ankle. The total time the fitness tracker is worn will be monitored by the device."}, {'measure': 'Knee Injury and Osteoarthritis Score (KOOS)', 'timeFrame': 'At baseline, 6 weeks, 3, 6, 12 and 24 months study visits', 'description': 'Participants will be asked to complete the Knee Injury and Osteoarthritis Score (KOOS) questionnaire to measure their overall well-being.\n\nKOOS uses a Likert scale ranging from 0 (No problems) to 4 (Extreme problems).'}, {'measure': '20-Item Short Form Survey (SF-20)', 'timeFrame': 'At baseline, 6 weeks, 3, 6, 12 and 24 months study visits', 'description': 'Participants will be asked to complete the 20-Item Short Form Survey Instrument (SF-20) questionnaire which measures their overall well-being including their physical and social functioning.'}, {'measure': 'Tegner Activity Scale', 'timeFrame': 'At baseline, 6 weeks, 3, 6, 12 and 24 months study visits', 'description': 'Participants will be asked to complete the Tegner Activity Scale questionnaire, which measures their level of activity.\n\nA 11-point scale (ranging from 0 - 10) is used where a higher score indicates higher level of activity.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recombinant Human Growth Hormone', 'rHGH', 'Saizen', 'Knee Osteoarthritis', 'Knee OA'], 'conditions': ['Knee Osteoarthritis (Knee OA)', 'Knee Osteoarthritis (OA)']}, 'referencesModule': {'references': [{'pmid': '14613558', 'type': 'BACKGROUND', 'citation': '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': '24423364', 'type': 'BACKGROUND', 'citation': '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': '14624771', 'type': 'BACKGROUND', 'citation': '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': '24382963', 'type': 'BACKGROUND', 'citation': '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': '28975078', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '22472350', 'type': 'BACKGROUND', 'citation': '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': '1550219', 'type': 'BACKGROUND', 'citation': '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': '30250451', 'type': 'BACKGROUND', 'citation': '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': '24946138', 'type': 'BACKGROUND', 'citation': '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': '8237325', 'type': 'BACKGROUND', 'citation': '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': '9951774', 'type': 'BACKGROUND', 'citation': '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': '20436717', 'type': 'BACKGROUND', 'citation': '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': '11834155', 'type': 'BACKGROUND', 'citation': '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': '35190919', 'type': 'BACKGROUND', 'citation': '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': '30871292', 'type': 'BACKGROUND', 'citation': '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': '24081158', 'type': 'BACKGROUND', 'citation': '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': '8067444', 'type': 'BACKGROUND', 'citation': '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': '13679302', 'type': 'BACKGROUND', 'citation': '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': '24810900', 'type': 'BACKGROUND', 'citation': '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': '20886766', 'type': 'BACKGROUND', 'citation': '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': '18193272', 'type': 'BACKGROUND', 'citation': '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': '34685644', 'type': 'BACKGROUND', 'citation': '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': '29489209', 'type': 'BACKGROUND', 'citation': 'Brinkman JE, Tariq MA, Leavitt L, Sharma S. Physiology, Growth Hormone. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482141/'}, {'pmid': '29636983', 'type': 'BACKGROUND', 'citation': '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': '28183213', 'type': 'BACKGROUND', 'citation': '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': '28183194', 'type': 'BACKGROUND', 'citation': '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.'}, {'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '20351594', 'type': 'BACKGROUND', 'citation': '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': '14656668', 'type': 'BACKGROUND', 'citation': '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': '24899825', 'type': 'BACKGROUND', 'citation': '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': '29358201', 'type': 'BACKGROUND', 'citation': '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': '23775341', 'type': 'BACKGROUND', 'citation': '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': '32452208', 'type': 'BACKGROUND', 'citation': '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': '35383651', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.emdserono.com/us-en/pi/saizen-ce-pi.pdf', 'label': 'Saizen Drug Monograph. Accessed October 15, 2024.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants will be asked to:\n\n* Self-inject the treatment solution (placebo or somatropin) into the abdominal or gluteal area once per day for a total of 6 weeks.\n* Complete questionnaires related to their knee pain and activities of daily living.\n* Provide blood tests.\n* Complete various measurements including: circumference of thigh, calf, and abdomen; strength of thigh and knee; range of motion of both knees; and gait analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 - 60 years old.\n* Diagnosis of isolated knee osteoarthritis for greater than 6 months.\n\nExclusion Criteria:\n\n* Previous or pending surgery to involved knee.\n* Previous major trauma to involved knee, or ipsilateral knee, hip, or ankle.\n* Recent (less than 6 months) intra-articular injection into the involved knee.\n* High grade ligamentous knee injury.\n* Known allergy to recombinant human growth hormone (rHGH) or reconstitutive solutions.\n* BMI of less than 20 or greater than 35.\n* 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.\n* Pregnant or breastfeeding, or actively attempting to get pregnant.\n* Currently on hypoglycemic therapy, oral estrogen or glucocorticoid replacement therapy.\n* Would have difficulty with the self-injection schedule or other cognitive/ functional limitations.\n* Vital signs or routine bloodwork outside of normal range.'}, 'identificationModule': {'nctId': 'NCT07036003', 'acronym': 'KORR', 'briefTitle': 'Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR): a Pilot, Randomized Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '6427'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recombinant Human Growth Hormone (rHGH)', 'description': 'Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.', 'interventionNames': ['Drug: Somatropin (recombinant human growth hormone)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Bacteriostatic Saline', 'description': 'Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.', 'interventionNames': ['Drug: bacteriostatic saline placebo']}], 'interventions': [{'name': 'Somatropin (recombinant human growth hormone)', 'type': 'DRUG', 'description': '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).', 'armGroupLabels': ['Recombinant Human Growth Hormone (rHGH)']}, {'name': 'bacteriostatic saline placebo', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Bacteriostatic Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Dr. David Wasserstein', 'role': 'CONTACT', 'email': 'david.wasserstein@sunnybrook.ca', 'phone': '416-480-5798'}, {'name': 'Dr. David Wasserstein', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Dr. David Wasserstein', 'role': 'CONTACT', 'email': 'david.wasserstein@sunnybrook.ca', 'phone': '416-480-5798'}], 'overallOfficials': [{'name': 'Dr. David Wasserstein', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. David Wasserstein', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sunnybrook Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor - University of Toronto; Associate Scientist - Sunnybrook Research Institute', 'investigatorFullName': 'Dr. David Wasserstein', 'investigatorAffiliation': 'Sunnybrook Health Sciences Centre'}}}}