Evaluating colchicine's effect on knee and hip replacements in osteoarthritis patients
The Effect of ColcHicine on the Incidence of Knee or Hip Replacements: a Randomized, Double-blind, Multicentre Study in Symptomatic Knee or Hip Osteoarthritis
This study is testing if taking colchicine every day can help people with osteoarthritis avoid needing knee or hip replacement surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1410 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Sint Maartenskliniek Academic / other |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT06578182 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess whether daily treatment with colchicine can reduce the incidence of knee or hip replacements in patients diagnosed with osteoarthritis. Participants will take colchicine or a placebo for a duration of 3 to 4.5 years, with regular clinic visits for check-ups, blood tests, and x-rays. The study will compare the outcomes of those receiving colchicine against those receiving a placebo to determine its effectiveness in managing osteoarthritis symptoms and preventing surgical interventions.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 to 80 with a clinical diagnosis of knee or hip osteoarthritis and documented radiographic changes.
Not a fit: Patients who are on a waiting list for joint replacement surgery or have had multiple previous replacements may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the need for knee and hip replacement surgeries in osteoarthritis patients.
How similar studies have performed: Previous studies have shown promising results with colchicine in other inflammatory conditions, but this specific application in osteoarthritis is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nijmegen
- Sint Maartenskliniek — Nijmegen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Tim Massa
- Email: t.massa@maartenskliniek.nl
- Phone: +31633036353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.