NCT06578182

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

The Effect of ColcHicine on the Incidence of Knee or Hip Replacements: a Randomized, Double-blind, Multicentre Study in Symptomatic Knee or Hip Osteoarthritis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,410 (estimated)
• Sponsor: Sint Maartenskliniek · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Osteoarthritis, Knee
• Osteoarthritis, Hip

Interventions

Type	Name	Description
DRUG	Colchicine	Colchicine 0.5mg tablets once a day for 3 to 4.5 years
DRUG	Placebo	Placebo tablets once a day for 3 to 4.5 years

Timeline

• Start date: 2025-01-01
• Primary completion: 2029-03-31
• Completion: 2029-03-31
• First posted: 2024-08-29
• Last updated: 2025-02-20

Locations

1 site across 1 country: Netherlands