Status:
RECRUITING
The Effect of ColcHicine on the Incidence of Knee or Hip Replacements
Lead Sponsor:
Sint Maartenskliniek
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
RSMK
Conditions:
Osteoarthritis, Knee
Osteoarthritis, Hip
Eligibility:
All Genders
45-80 years
Phase:
PHASE3
Brief Summary
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 occ...
Eligibility Criteria
Inclusion
- clinical diagnosis of knee or hip OA
- 45 ≤ age ≤ 80 (upper age limit is similar to that in the LoDoCo2 trial and takes in consideration the lower number of joint replacements in people older than 80 years)
- documented radiographic changes typical for advanced knee/hip OA (Kellgren \& Lawrence score ≥ 2), or at least 2-year history of complaints due to OA in the hip and/or knee
Exclusion
- On a waiting list for primary joint replacement surgery of the hip or knee, irrespective of cause
- Any absolute contraindication for knee or hip replacement in the future
- More than one previous hip or knee replacements
- Other known medical disease that may affect joints
- Known generalized pain syndromes such as fibromyalgia
- Renal impairment as evidenced by serum creatinine \>150µmol/l or estimated glomerular filtration rate (eGFR) \<50mL/min/1.73m2
- Liver function impairment as evidenced by serum alanine transferase (ALAT) \> 3 ULN (upper limit of normal)
- Blood dyscrasia
- High frailty (clinical frailty scale ≥ 7) or predicted life expectancy \< 5 years
- Peripheral neuritis, myositis or marked myo-sensitivity to statins
- Current use of colchicine for another indication
- Intolerance to colchicine
- use of macrolide antibiotics (i.e. clarithromycin, erythromycin, azithromycin), antimycotics (i.e. ketoconazole, itraconazole and voriconazole), protease inhibitors \& anti-retroviral drugs (i.e. ritonavir, lopinavir, tipranavir, atazanavir, darunavir, indinavir, saquinavir, and cobicistat), anti-arrhythmic drugs (i.e. verapamil, diltiazem), or immunosuppressant (i.e. cyclosporine)
- Current enrollment in another trial
- Incapacitated patients
- Pregnant or breastfeeding female
- Fertile female participants not taking sufficient anti-conception
- Male participants unwilling to use effective contraception during the study to prevent pregnancy
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
1410 Patients enrolled
Trial Details
Trial ID
NCT06578182
Start Date
January 1 2025
End Date
March 31 2029
Last Update
February 20 2025
Active Locations (1)
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1
Sint Maartenskliniek
Nijmegen, Netherlands