Actively Recruiting
The Effect of ColcHicine on the Incidence of Knee or Hip Replacements
Led by Sint Maartenskliniek · Updated on 2025-02-20
1410
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
S
Sint Maartenskliniek
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip osteoarthritis on the incidence of first occurrence of knee or hip replacement. The main question it aims to answer is: Does colchicine lower the number of knee or hip replacements in participants with osteoarthritis? Researchers will compare colchicine to a placebo (a look-alike substance that contains no drug) to see if colchicine works to treat osteoarthritis. Participants will: * take colchicine every day for 3 tot 4.5 years * visit the clinic every year for check-up and tests such as blood samples and x-rays * fill in questionnaires every 3 months
CONDITIONS
Official Title
The Effect of ColcHicine on the Incidence of Knee or Hip Replacements
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of knee or hip osteoarthritis
- Age between 45 and 80 years
- Radiographic evidence of advanced knee or hip osteoarthritis (Kellgren & Lawrence score of 2 or higher), or at least a 2-year history of osteoarthritis symptoms in the hip and/or knee
You will not qualify if you...
- On a waiting list for primary knee or hip replacement surgery
- Any absolute contraindication for future knee or hip replacement
- More than one previous hip or knee replacement
- Other known medical diseases affecting joints
- Known generalized pain syndromes such as fibromyalgia
- Renal impairment shown by serum creatinine over 150 µmol/l or eGFR below 50 mL/min/1.73m2
- Liver function impairment with serum alanine transferase over three times the upper limit of normal
- Blood disorders
- High frailty (clinical frailty scale of 7 or higher) or predicted life expectancy under 5 years
- Peripheral neuritis, myositis, or marked sensitivity to statins
- Current use of colchicine for other reasons
- Intolerance to colchicine
- Use of certain antibiotics, antifungals, protease inhibitors, anti-arrhythmic drugs, or immunosuppressants
- Current participation in another clinical trial
- Incapacitated patients
- Pregnant or breastfeeding women
- Fertile women not using effective contraception
- Men unwilling to use effective contraception during the study to prevent pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sint Maartenskliniek
Nijmegen, Netherlands
Actively Recruiting
Research Team
T
Tim Massa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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