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New treatment option for Knee Osteoarthritis (Knee OA)
Official title Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)
ClinicalTrials.gov ID: NCT07036003
What this study is testing
What is Somatropin (recombinant human growth hormone)?
Somatropin (recombinant human growth hormone) is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for knee osteoarthritis (knee oa).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Between 18 - 65 years old.
- Diagnosis of isolated knee osteoarthritis for greater than 6 months.
You likely can't join if
- Previous or pending major intra-articular or reconstructive surgery to the involved knee, including femoral/tibial osteotomies, ligament...
- Previous major trauma (including fracture, dislocation, open injury) to the involved knee, or ipsilateral hip, knee, ankle, or hip. Patients with...
- 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.
See the full eligibility criteria
- Between 18 - 65 years old.
- Diagnosis of isolated knee osteoarthritis for greater than 6 months.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.