STOP KNEE-OA: AVOIDING COSTLY SURGERY THROUGH
WEIGHT LOSS
THE STOP-KNEE OA TRIAL
Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA) Trial aims to systematically evaluate the efficacy and safety of a new hypoglycemic drug, tirzepatide, for treating obesity and knee osteoarthritis based on indicators such as BMI, waist circumference, and body weight.
ENROLMENT
352 Patients
18+ Years. All genders
INSIGHT:
Estimated study start date: May 2024
Estimated study completion date: May 2037
NEWS
“Michelle Dowsey’s finding is part of the solution to Australia’s productivity problem, which is particularly acute in healthcare. The cost of medical and hospital services has tripled since 2000”
AUSTRALIAN FINANCIAL REVIEW
BACKGROUND
Obesity is not only a chronic metabolic disease, but also a major public health issue. In the past 50 years, the number of people worldwide suffering from obesity has tripled, with over 650 million adults considered obese and at least 1.9 billion adults overweight.
Knee replacements due to obesity consume more of the health budget than any other surgical procedure.
In an experiment on 82 very overweight patients at St Vincent’s Hospital in Melbourne, 29 per cent cancelled planned knee replacements after quickly losing weight. Their knees felt better.
The main purpose of this study is to see if tirzepatide can reduce number of these participants who require a knee replacement. Participants will be randomised to take a weekly injection of tirzepatide or a placebo for a total of 72 weeks.
STOP KNEE-OA has been designed to test multiple treatments within a common research platform. This design is more efficient and will lead to a shorter time for patients to receive effective treatments. The trial is 'eternal', which means that participants will continue to be recruited for many years until the trial is finally wound up. It is also 'adaptive', providing the flexibility to add new treatments, or remove those that are not working.
TRIAL DESIGN
Interventional, randomised clinical trial.
Drug: Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1receptor (GLP1R) agonist Dose: Tirzepatide will be initiated at 2.5mg once weekly, with the dose increasing by a further 2.5mg every four weeks until the target weekly dose of 15mg is achieved (or participants reach a lower maximum tolerated dose of 5mg or 10mg).
Duration: 72-weeks Mode: subcutaneous
Location: Australia
352 participants in two patient groups including a placebo group
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Outcome measures: Percentage of patients who undergo knee replacement in the target joint. Time Frame: within 72 weeks of randomization
KEY CONNECTIONS
PRINCIPAL INVESTIGATOR - Professor Michelle Dowsey University of Melbourne
CENTRAL TRIAL CONTACT: Angela Cochrane, St Vincent’s Hospital Melbourne
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Our Spiral Project Lead and EDC Platform manager for the STOP KNEE-OA study is Emma Winks
As a Project Manager at Spiral, Emma oversees software development used in clinical trials. She is used to working with lots of moving parts with a laser-beam focus.
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“It is an incredibly agile environment. Whatever comes my way - I jump on it and deal with it”