Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 65Years
All Genders
ID07036003

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

Led by Dr. David Wasserstein · Updated on 2026-03-16

34

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

D

Dr. David Wasserstein

Lead Sponsor

S

Sunnybrook Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether people with knee osteoarthritis can successfully incorporate Recombinant Human Growth Hormone (rHGH), specifically Saizen Somatropin solution, into their treatment plan. This pilot, randomized placebo-controlled trial aims to assess the feasibility of daily self-injection and its effects on various clinical outcomes over time. Participants have a diagnosis of isolated knee osteoarthritis lasting more than six months and are aged 18 to 65 years. Participants will self-inject either somatropin or a placebo solution once daily into the abdomen or gluteal area for six weeks. The dose of somatropin is 0.5 mg per square meter of body surface area per day. The study includes a placebo group receiving bacteriostatic saline in an identical injection device. This intervention period is followed by extended observation and assessments up to 24 months to monitor various muscle strength, circumference, range of motion, gait, and activity measures. During the study, participants will complete questionnaires related to knee pain and daily activities, provide blood samples, and undergo multiple physical measurements including thigh, calf, and abdominal circumferences, knee strength, range of motion, and gait analysis. These assessments occur at baseline, six weeks, and multiple follow-up points up to two years. The primary outcome is the feasibility of medication administration at six weeks. Researchers will monitor clinical outcomes such as muscle strength, walking ability, and activity levels over the study duration.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 65 years old
  • Diagnosis of isolated knee osteoarthritis for more than 6 months
Not Eligible

You will not qualify if you...

  • Previous or pending major intra-articular or reconstructive surgery to the involved knee, including osteotomies, ligament repair, or cartilage transplantation
  • Major trauma to the involved knee or nearby joints, including fractures or dislocations
  • Recent intra-articular injection into the involved knee within the last 6 months
  • High grade ligamentous knee injury
  • Known allergy to recombinant human growth hormone or related solutions
  • Body mass index less than 20 or greater than 35
  • History of bone or connective tissue growth disorders, diabetes, myopathy, cancer, endocrine disorders, severe hypertension, or rheumatologic disease
  • Pregnant, breastfeeding, or actively trying to become pregnant
  • Currently on hypoglycemic therapy, oral estrogen, or glucocorticoid replacement therapy
  • Difficulty with self-injection schedule or cognitive/functional limitations
  • Use of creatine within 7 days before baseline
  • Use of anabolic steroids within 42 days before baseline
  • Vital signs or routine bloodwork outside normal range

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants self-administer recombinant human growth hormone or placebo via subcutaneous injection once daily for six weeks.

Daily self-administration with scheduled study visits

Follow-up

Duration - Up to 24 months

Participants attend follow-up visits for clinical assessments and outcome measurements after treatment ends.

Multiple visits at 6 weeks, 3, 6, 12, and 24 months

Trial Site Locations

Total: 1 location

1

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

D

Dr. David Wasserstein

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Effects of recombinant human growth hormone therapy on bone mineral density in adults with growth hormone deficiency: a meta-analysis.

Maya Barake, Anne Klibanski, Nicholas A Tritos

https://pubmed.ncbi.nlm.nih.gov/24423364

Adding Intra-Articular Growth Hormone to Platelet Rich Plasma under Ultrasound Guidance in Knee Osteoarthritis: A Comparative Double-Blind Clinical Trial.

Poupak Rahimzadeh, Farnad Imani, Seyed-Hamid-Reza Faiz...

https://pubmed.ncbi.nlm.nih.gov/28975078

Phase 2 Randomized, Placebo-Controlled Clinical Trial of Recombinant Human Growth Hormone (rhGH) During Rehabilitation From Traumatic Brain Injury.

Rosemary Dubiel, Librada Callender, Cynthia Dunklin...

https://pubmed.ncbi.nlm.nih.gov/30250451

Effect of Recombinant Human Growth Hormone on Osseointegration of Titanium Implants: A Histologic and Biomechanical Study in Rabbits.

Marcelo Emir Requia Abreu, Renato Valiati, Roberto Hubler...

https://pubmed.ncbi.nlm.nih.gov/24946138