RecruitingPhase 1Phase 2NCT07036003

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

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

Sponsor

Dr. David Wasserstein

Enrollment

34 participants

Start Date

Oct 31, 2025

Study Type

INTERVENTIONAL

Conditions

Knee Osteoarthritis (Knee OA)Knee osteoarthritis (OA)

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether recombinant human growth hormone (rHGH, specifically Saizen somatropin) given as daily self-injections for 6 weeks can reduce pain and improve function in people with knee osteoarthritis — a degenerative condition in which joint cartilage breaks down, causing pain, stiffness, and reduced mobility. The main goal is also to assess whether patients are willing and able to comply with the daily injection schedule. Adults aged 18–65 with a diagnosis of isolated knee osteoarthritis for more than 6 months, a BMI between 20 and 35, and no prior major knee surgery may be eligible. Participation involves daily self-injection of rHGH or a placebo for 6 weeks, completing pain and function questionnaires, blood tests, and physical measurements of the knee and leg. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSomatropin (recombinant human growth hormone)

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).

DRUGbacteriostatic saline placebo

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.