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| Name | Class |
|---|---|
| Sunnybrook Research Institute | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant Human Growth Hormone (rHGH) | Experimental | Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks. |
|
| Bacteriostatic Saline | Placebo Comparator | Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the medication administration | Participant adheres to self-administration of injections once daily for 6 weeks. | 6 weeks after treatment begins. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes: knee extension strength | Participants' knee extension strength will be measured using HUMAC Norm Extremity Strength Testing system. | At 6 weeks and 24 months time points after enrolment |
| Clinical Outcome: knee flexion strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Wasserstein | Contact | 416-480-5798 | david.wasserstein@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Dr. David Wasserstein | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14613558 | 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. | |
| 24423364 | 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. |
| Label | URL |
|---|---|
| Saizen Drug Monograph. Accessed October 15, 2024. | View source |
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Data Sharing Statement: All data relevant to the study will be included in the final study manuscript or uploaded as supplementary information.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 3 months and ending 5 years following article publication.
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.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| 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. |
|
Participants' knee flexion strength will be measured using HUMAC Norm Extremity Strength Testing system.
| At 24 months after enrolment. |
| Clinical Outcomes: thigh muscle strength | Participants' thigh muscle strength will be measured through hip flexion, hip abduction and knee flexion using a goniometer. | At baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months study visits. |
| Clinical Outcomes: Kinematic Gait Analysis | 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. | At baseline, 6 weeks and 6 months study visits. |
| Thigh circumference | Participant's measurements of function will be measured by their thigh circumference compared to the contralateral leg, and baseline. | At baseline, 6 weeks, 3, 6, 12 and 24 months study visits |
| Mid-calf circumference | Participant's measurements of function will be measured by their mid-calf circumference compared to the contralateral leg, and baseline. | At baseline, 6 weeks, 3, 6, 12 and 24 months study visits |
| Abdominal circumference | Participant's measurements of function will be measured by their abdominal circumference. | At baseline, 6 weeks, 3, 6, 12 and 24 months study visits |
| Range of motion of both knees | Participant's measurements of function will be measured by Range of motion of both knees. | At baseline, 6 weeks, 3, 6, 12 and 24 months study visits |
| 6 Minute Walk Test (6MWT) | Participants' distance traveled in the span of 6 minutes will be measured on a treadmill (unit: total meters). | At baseline, 6 weeks, 3 months, 6 months, and 12 months after enrolment. |
| Activity Count | 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. | From enrolment to the 12-week study visit. |
| Knee Injury and Osteoarthritis Score (KOOS) | Participants will be asked to complete the Knee Injury and Osteoarthritis Score (KOOS) questionnaire to measure their overall well-being. KOOS uses a Likert scale ranging from 0 (No problems) to 4 (Extreme problems). | At baseline, 6 weeks, 3, 6, 12 and 24 months study visits |
| 20-Item Short Form Survey (SF-20) | 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. | At baseline, 6 weeks, 3, 6, 12 and 24 months study visits |
| Tegner Activity Scale | Participants will be asked to complete the Tegner Activity Scale questionnaire, which measures their level of activity. A 11-point scale (ranging from 0 - 10) is used where a higher score indicates higher level of activity. | At baseline, 6 weeks, 3, 6, 12 and 24 months study visits |
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| 41638751 | Derived | 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. |
| D012216 |
| Rheumatic Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |