Growth Hormone for Osteoarthritis

(KORR Trial)

Overseen By Dr. David Wasserstein

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Dr. David Wasserstein

Must not be taking: Hypoglycemics, Oral estrogen, Glucocorticoids

Disqualifiers: Knee surgery, Trauma, Diabetes, others

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if individuals with knee osteoarthritis are willing to use a daily self-injection treatment involving Recombinant Human Growth Hormone (rHGH, also known as Somatropin). The study will compare rHGH with a placebo to assess adherence to the treatment plan and its effects on knee pain and daily activities. Participants will self-inject the treatment into their abdomen or gluteal area daily for six weeks and complete several assessments and blood tests. Those with knee osteoarthritis for more than six months, who have not had recent knee surgeries or major injuries, may be suitable candidates. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's mechanism and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently on hypoglycemic therapy, oral estrogen, or glucocorticoid replacement therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that somatropin, a type of human growth hormone, is generally safe for patients. Other studies have used it safely for conditions like growth hormone deficiency and other growth-related issues. However, some safety concerns exist. The FDA has noted a possible increased risk of death with somatropin use, though this is not fully confirmed.

Overall, while somatropin is usually safe, awareness of these potential risks is important. Clinical trial participants will receive close monitoring for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for osteoarthritis?

Unlike the standard treatments for osteoarthritis, which often include pain relievers and anti-inflammatory drugs, somatropin, a form of recombinant human growth hormone (rHGH), offers a novel approach. Researchers are excited about somatropin because it may help improve joint function and repair cartilage, going beyond just symptom relief. This treatment is self-administered through a daily subcutaneous injection, potentially making it a convenient option for patients. By targeting the root causes of joint degeneration, somatropin has the potential to provide long-term benefits that current therapies do not offer.

What evidence suggests that this treatment might be an effective treatment for osteoarthritis?

Research has shown that somatropin, a type of human growth hormone, may help treat knee osteoarthritis. In this trial, participants will receive either recombinant human growth hormone (rHGH) or a placebo comparator. Studies have found that growth hormone injections can help rebuild cartilage and reduce knee pain. Further research indicates that using growth hormone with other treatments, like platelet-rich plasma, can improve knee movement. Additionally, trials suggest that these injections can boost cartilage health and joint function. These findings suggest that somatropin could effectively manage knee osteoarthritis symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

Dr. David Wasserstein

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for individuals with knee osteoarthritis who are willing to self-inject a treatment into their abdomen or gluteal area twice daily for 6 weeks, complete questionnaires, provide blood tests, and undergo measurements of thigh, calf, abdomen, strength and range of motion of knees.

Inclusion Criteria

I am between 18 and 60 years old.

I have been diagnosed with knee osteoarthritis for over 6 months.

Exclusion Criteria

I have had or will have surgery on my affected knee.

Previous major trauma to involved knee, or ipsilateral knee, hip, or ankle

Known allergy to recombinant human growth hormone (rHGH) or reconstitutive solutions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-inject the treatment solution (placebo or somatropin) into the abdominal or gluteal area twice per day for a total of 6 weeks. They also complete questionnaires, provide blood tests, and undergo various physical measurements.

6 weeks

Weekly visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including KOOS, range of motion, and other physical measurements.

24 months

Visits at 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Somatropin

Trial Overview The study is testing the effectiveness of Recombinant Human Growth Hormone (rHGH), specifically Saizen Somatropin solution. Participants will either receive this hormone or a placebo without active ingredients to compare outcomes in managing knee osteoarthritis.

How Is the Trial Designed?

Group I: Recombinant Human Growth Hormone (rHGH) Experimental Treatment 1 Intervention

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

Group II: Bacteriostatic Saline Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Dr. David Wasserstein

Lead Sponsor

Sunnybrook Research Institute

Collaborator

Trials

33

Recruited

216,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06354023

Human Growth Hormone Injections in the Knee Joint to ... Clinical and non-clinical studies of repeated intra-articular human growth hormone injections have shown to regrow cartilage and reduce symptoms of ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5560632/

Adding Intra-Articular Growth Hormone to Platelet Rich ... These results showed that adding growth hormone to platelet rich plasma for intra-articular injection improved function of the osteoarthritic knee joint in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07036003

Recombinant Human Growth Hormone (rHGH) for Knee ... 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 ...

4. app.trialscreen.org app.trialscreen.org/trials/phase-2-human-growth-hormone-injections-knee-joint-to-treat-osteoarthritis-trial-nct06354023

Human Growth Hormone Injections in the Knee Joint to ... The trial seeks to answer critical questions about the efficacy of growth hormone injections in improving cartilage health and overall joint function in knee ...

5. jksrr.org jksrr.org/journal/view.html?uid=1172&vmd=Full

Intra-articular Recombinant Human Growth Hormone Injection ... Intra-articular injection of GH showed better clinical, macroscopic and microscopic results as compared to HA and placebo. Keywords: Knee, ...

6. fda.gov fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-safety-review-update-recombinant-human-growth-hormone-somatropin-and

Safety review update of Recombinant Human Growth ... FDA Drug Safety Communication: Safety review update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3678547/

Growth Hormone and Treatment Controversy; Long Term ... This review will examine the issue of safety of rGH in order that practitioners are informed as they consider initiation of therapy with patients. Keywords: ...

8. go.drugbank.com go.drugbank.com/drugs/DB00052

Somatotropin: Uses, Interactions, Mechanism of Action Somatotropin is a recombinant human growth hormone used as replacement therapy in various conditions of growth failure, growth hormone deficiency, ...