The Effect of ColcHicine on the Incidence of Knee or Hip Replacements
Key facts
- Where
- Alkmaar, Amsterdam, Arnhem, Ede Gld, Nijmegen, Ubbergen, and Zoetermeer, NetherlandsSee the 7 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 80 years old?
Source: NCT06578182, who can take part
Where in Netherlands
- Noordwest Ziekenhuisgroep StichtingAlkmaar, NetherlandsTaking people
- Reade revalidatie & reumatologie centrum te AmsterdamAmsterdam, NetherlandsTaking people
- Rijnstate Ziekenhuis StichtingArnhem, NetherlandsTaking people
- Ziekenhuis Gelderse Vallei StichtingEde Gld, NetherlandsTaking people
- Canisius Wilhelmina ZiekenhuisNijmegen, NetherlandsTaking people
- Sint Maartenskliniek StichtingUbbergen, NetherlandsTaking people
- Reinier Haga Groep Orthopedisch Centrum B.V.Zoetermeer, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sint Maartenskliniek
- Trial code
- NCT06578182EU 2024-511359-16-00
- Record updated
- 20 February 2025
- Original description
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:Read full original descriptionShow less
The Effect of ColcHicine on the Incidence of Knee or Hip Replacements: a Randomized, Double-blind, Multicentre Study in Symptomatic Knee or Hip Osteoarthritis
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
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; More than one previous hip or knee replacements; 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); 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); High frailty (clinical frailty scale ≥ 7) or predicted life expectancy < 5 years; Any absolute contraindication for knee or hip replacement in the future; Blood dyscrasia; Peripheral neuritis, myositis or marked myo-sensitivity to statins; Current use of colchicine for another indication; Intolerance to colchicine; 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.