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

Dr. David Wasserstein

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Knee Osteoarthritis (OA); Knee Osteoarthritis (Knee OA)

Treatments: Drug: Somatropin (recombinant human growth hormone); Drug: bacteriostatic saline placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07036003

6427

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

Recombinant Human Growth Hormone (rHGH)

Experimental group

Description:

Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.

Treatment:

Drug: Somatropin (recombinant human growth hormone)

Bacteriostatic Saline

Placebo Comparator group

Description:

Self-administered subcutaneous injection into the abdomen or gluteal region once per day for six weeks.

Treatment:

Drug: bacteriostatic saline placebo