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NCT Number: NCT07036003

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

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.

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Key information

Conditions

Knee Osteoarthritis (Knee OA) Arthritis Joint Diseases Knee Osteoarthritis (OA) Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location status: Recruiting

Location contact

Dr. David Wasserstein

CONTACT

[email protected]

416-480-5798

Dr. David Wasserstein

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 18 - 65 years old.
  • Diagnosis of isolated knee osteoarthritis for greater than 6 months.

Exclusion criteria

  • Previous or pending major intra-articular or reconstructive surgery to the involved knee, including femoral/tibial osteotomies, ligament repair/reconstruction, or cartilage transplantation. Patients with remote (>1 year) diagnostic arthroscopy, arthroscopic debridement, meniscectomy, or meniscal repair may be allowed to participate at the investigators' discretion.
  • Previous major trauma (including fracture, dislocation, open injury) to the involved knee, or ipsilateral hip, knee, ankle, or hip. Patients with prior complete ligament tears will be excluded, patients with chronic partial thickness ligament tears or degenerative/complex meniscal tears (>6 months from injury) may be included at the investigators' discretion
  • 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.
  • Have taken creatine within 7 days before baseline. Potential participants will be given the option to pause their supplements and then re-screen if they are interested in the study,
  • Have taken anabolic steroids within 42 days (6 weeks) before baseline. Potential participants will be given the option to pause their supplements and then rescreen if they are interested in the study,
  • Vital signs or routine bloodwork outside of normal range.

Treatment and study plan

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).

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.

Primary outcomes

  1. Feasibility of the medication administration

    Time frame: 6 weeks after treatment begins.

    Participant adheres to self-administration of injections once daily for 6 weeks.

Secondary outcomes

  1. Clinical Outcomes: knee extension strength

    Time frame: At 6 weeks and 24 months time points after enrolment

    Participants' knee extension strength will be measured using HUMAC Norm Extremity Strength Testing system.

  2. Clinical Outcome: knee flexion strength

    Time frame: At 24 months after enrolment.

    Participants' knee flexion strength will be measured using HUMAC Norm Extremity Strength Testing system.

  3. Clinical Outcomes: thigh muscle strength

    Time frame: 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.

  4. Clinical Outcomes: Kinematic Gait Analysis

    Time frame: 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.

  5. Thigh circumference

    Time frame: 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.

  6. Mid-calf circumference

    Time frame: 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.

  7. Abdominal circumference

    Time frame: At baseline, 6 weeks, 3, 6, 12 and 24 months study visits

    Participant's measurements of function will be measured by their abdominal circumference.

  8. Range of motion of both knees

    Time frame: 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.

  9. 6 Minute Walk Test (6MWT)

    Time frame: 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).

  10. Activity Count

    Time frame: 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.

  11. Knee Injury and Osteoarthritis Score (KOOS)

    Time frame: 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).

  12. 20-Item Short Form Survey (SF-20)

    Time frame: 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.

  13. Tegner Activity Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. David Wasserstein

CONTACT

[email protected]

416-480-5798

Sponsors and collaborators

Lead sponsor

Dr. David Wasserstein

Other

Collaborators

  • Sunnybrook Research Institute

Registry information

Official study title

Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR): a Pilot, Randomized Placebo-controlled Trial

Acronym: KORR

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 25, 2025
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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