NCT06578182 The Effect of ColcHicine on the Incidence of Knee or Hip Replacements

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.

This trial targets 1,410 participants in total. It began in 2025-01-01 with a primary completion date of 2029-03-31.

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 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

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

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