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

Phase 1

Not yet recruiting

• Conditions: Knee Osteoarthritis (Knee OA); Knee Osteoarthritis (OA)
• Interventions: Drug: Somatropin (recombinant human growth hormone); Drug: bacteriostatic saline placebo

• Registration Number: NCT07036003
• Lead Sponsor: Dr. David Wasserstein

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-30
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-16
• Study First Posted: 2025-06-25
• Last Update Submitted: 2025-09-12
• Last Update Posted: 2025-09-18
• Study Start: 2025-10-01
• Primary Completion: 2028-07
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Between 18 - 60 years old.
• Diagnosis of isolated knee osteoarthritis for greater than 6 months.

Exclusion Criteria

• Previous or pending surgery to involved knee.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recombinant Human Growth Hormone (rHGH)	Somatropin (recombinant human growth hormone)	Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.
Bacteriostatic Saline	bacteriostatic saline placebo	Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.

Primary Outcome Measures

Name	Time	Method
Feasibility of the medication administration	6 weeks after treatment begins.	Participant adheres to self-administration of injections once daily for 6 weeks.

Secondary Outcome Measures

Name	Time	Method
Clinical Outcomes: knee extension strength	At 6 weeks and 24 months time points after enrolment	Participants' knee extension strength will be measured using HUMAC Norm Extremity Strength Testing system.
Clinical Outcome: knee flexion strength	At 24 months after enrolment.	Participants' knee flexion strength will be measured using HUMAC Norm Extremity Strength Testing system.
Clinical Outcomes: thigh muscle strength	At baseline, 6 weeks, 3 months, 6 months, 12 months, and 24 months study visits.	Participants' thigh muscle strength will be measured through hip flexion, hip abduction and knee flexion using a goniometer.
Clinical Outcomes: Kinematic Gait Analysis	At baseline, 6 weeks and 6 months study visits.	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.
Thigh circumference	At baseline, 6 weeks, 3, 6, 12 and 24 months study visits	Participant's measurements of function will be measured by their thigh circumference compared to the contralateral leg, and baseline.
Mid-calf circumference	At baseline, 6 weeks, 3, 6, 12 and 24 months study visits	Participant's measurements of function will be measured by their mid-calf circumference compared to the contralateral leg, and baseline.
Abdominal circumference	At baseline, 6 weeks, 3, 6, 12 and 24 months study visits	Participant's measurements of function will be measured by their abdominal circumference.
Range of motion of both knees	At baseline, 6 weeks, 3, 6, 12 and 24 months study visits	Participant's measurements of function will be measured by Range of motion of both knees.
6 Minute Walk Test (6MWT)	At baseline, 6 weeks, 3 months, 6 months, and 12 months after enrolment.	Participants' distance traveled in the span of 6 minutes will be measured on a treadmill (unit: total meters).
Activity Count	From enrolment to the 12-week study visit.	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.
Knee Injury and Osteoarthritis Score (KOOS)	At baseline, 6 weeks, 3, 6, 12 and 24 months study visits	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).
20-Item Short Form Survey (SF-20)	At baseline, 6 weeks, 3, 6, 12 and 24 months study visits	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.
Tegner Activity Scale	At baseline, 6 weeks, 3, 6, 12 and 24 months study visits	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.

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada