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

Study acronym: ECHO
StatusRecruiting
PhasePhase 3
Started2025-01-01
View on ClinicalTrials.gov ↗

Amendment history

2025-02-18
Not Yet Recruiting→Recruiting Study Status, Study Design, Outcome Measures, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Enrollment target1200→1410
Study sites0→1
Secondary endpoints11 entries, revised
RadiologicalCourse progressionof joint space narrowing on X-ray ChangeCourse inof low-grade inflammation as assessed by hs-CRP Number of part [...] l or radiological onset of OA in new joint group other than hippresent and/orat kneebaseline over the trial period Time to clinical or radiological onset of OA in new joint group other than hippresent and/orat kneebaseline over the trial period
2024-12-02
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v1
Start date2024-10-01→2025-01-01
Eligibility criteria+669 characters
[...] laints due to OA in the hip and/or knee Exclusion Criteria: IndicationOn a waiting list for primary joint replacement surgery of the hip or knee, irrespective of cause AbsoluteAny absolute contraindication for knee or hip replacement in the future [...] > 3 ULN (upper limit of normal) Blood dyscrasia High frailty (clinical frailty scale ≥ 7) or predicted life expectancy < 5 years Peripheral neuritis, [...] 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, itra [...] [...]
Secondary endpointsdetails revised at 11 of 11 entries
Collaborators3 to 4 entries
Dutch Arthritis Foundation Reuma Nederland
2024-08-27
Original filing
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
Trial Details
NCT Number NCT06578182
Lead Sponsor Sint Maartenskliniek
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development, RSMK, Tiofarma, Dutch Arthritis Foundation Reuma Nederland
Conditions Osteoarthritis, Knee, Osteoarthritis, Hip
Enrollment 1,410 participants
Start Date 2025-01-01
Primary Completion 2029-03-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-20