Daily recombinant human growth hormone (rHGH) for knee osteoarthritis
Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR): a Pilot, Randomized Placebo-controlled Trial
This test will see if adults with isolated knee osteoarthritis can stick with and tolerate daily self‑injected recombinant human growth hormone (Saizen) or placebo for six weeks.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07036003 on ClinicalTrials.gov |
What this trial studies
This single‑center Phase 1/2 interventional trial asks participants to self‑inject either somatropin (rHGH) or a bacteriostatic saline placebo once daily for six weeks. Participants will complete knee pain and daily‑living questionnaires, provide blood tests, and undergo physical measures including limb circumferences, thigh and knee strength, knee range of motion, and gait analysis. The trial focuses primarily on adherence, tolerability, and preliminary safety signals rather than long‑term disease modification. Conducted at Sunnybrook Health Sciences Centre, it uses standard clinical and functional outcome measures to collect early human data on this approach.
Who should consider this trial
Good fit: Adults aged 18–65 with isolated knee osteoarthritis for at least six months who are willing and able to self‑inject daily and attend follow‑up visits are ideal candidates.
Not a fit: People with recent major knee trauma or surgery, recent intra‑articular injections, high‑grade ligament injuries, pending knee reconstructive procedures, or those outside the 18–65 age range are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, this could show that a short course of self‑administered rHGH is acceptable to patients and may offer a new option to improve symptoms or function in knee osteoarthritis.
How similar studies have performed: Use of recombinant human growth hormone for knee osteoarthritis is largely experimental with limited prior clinical evidence, so this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Dr. David Wasserstein — Sunnybrook Health Sciences Centre
- Study coordinator: Dr. David Wasserstein
- Email: david.wasserstein@sunnybrook.ca
- Phone: 416-480-5798
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.