Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)
NCT ID: NCT07036003
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2025-10-31
2029-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Recombinant Human Growth Hormone (rHGH)
Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.
Somatropin (recombinant human growth hormone)
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).
Bacteriostatic Saline
Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.
bacteriostatic saline placebo
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.
Interventions
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Somatropin (recombinant human growth hormone)
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).
bacteriostatic saline placebo
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of isolated knee osteoarthritis for greater than 6 months.
Exclusion Criteria
* Previous major trauma to involved knee, or ipsilateral knee, hip, or ankle.
* 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.
* Vital signs or routine bloodwork outside of normal range.
18 Years
60 Years
ALL
No
Sponsors
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Sunnybrook Research Institute
OTHER
Dr. David Wasserstein
OTHER
Responsible Party
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Dr. David Wasserstein
Assistant Professor - University of Toronto; Associate Scientist - Sunnybrook Research Institute
Principal Investigators
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Dr. David Wasserstein
Role: PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Locations
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Dr. David Wasserstein
Role: primary
References
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Related Links
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Saizen Drug Monograph. Accessed October 15, 2024.
Other Identifiers
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6427
Identifier Type: -
Identifier Source: org_study_id