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Colchicine for the treatment of hip and knee osteoarthritis.
EU CTIS ID: 2024-511359-16-00
What this study is testing
To evaluate the effect of treatment with colchicine 0.5mg once daily as compared to placebo in patients with knee or hip OA on the incidence of first occurrence of knee or hip replacement.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Clinical diagnosis of knee or hip OA
- 45 ≤ age ≤ 80
- 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
You likely can't join if
- On a waiting list for primary joint replacement surgery of the hip or knee, irrespective of cause
- Male participants unwilling to use effective contraception during the study to prevent pregnancy
- Peripheral neuritis, myositis or marked myo-sensitivity to statins
- Current use of colchicine for another indication
- Current enrollment in another trial
- Any absolute contraindication for knee or hip replacement in the future
See the full eligibility criteria
- Clinical diagnosis of knee or hip OA
- 45 ≤ age ≤ 80
- 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
- On a waiting list for primary joint replacement surgery of the hip or knee, irrespective of cause
- Male participants unwilling to use effective contraception during the study to prevent pregnancy
- Peripheral neuritis, myositis or marked myo-sensitivity to statins
- Current use of colchicine for another indication
- Current enrollment in another trial
- 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
- Inability to speak, read, or write in Dutch
- Liver function impairment as evidenced by serum alanine transferase (ALAT) > 3 ULN (upper limit of normal)
- Lowered blood cell counts: anaemia (haemoglobin <8.0 mmol/l in males or <7.0 mmol/l in females), leukopenia (< 3.5e9 leucocytes per litre), and/or thrombocytopenia (< 100e9 thrombocytes per litre)
- High frailty (Clinical Frailty Scale ≥ 7) or predicted life expectancy < 5 years
- 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), use of immunosuppressant (i.e. ciclosporine)
- Intolerance to colchicine
- Incapacitated patients
- Pregnant or breastfeeding female
- Fertile female participants not taking sufficient anti-conception
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.