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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Sint Maartenskliniek
RECRUITING
Nijmegen
Contact Information
Primary
Tim Massa
t.massa@maartenskliniek.nl
+31633036353
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 1410
Treatments
Experimental: Colchicine
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Collaborators: Dutch Arthritis Foundation Reuma Nederland, RSMK, ZonMw: The Netherlands Organisation for Health Research and Development, Tiofarma
Leads: Sint Maartenskliniek

This content was sourced from clinicaltrials.gov