The Effect of ColcHicine on the Incidence of Knee or Hip Replacements
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age45-80
SponsorSint Maartenskliniek
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Colchicine
- Placebo
Treatment groups
1,410 Participants
are divided into 2 treatment groupsSponsors and collaborators
Sint Maartenskliniek
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
RSMK
Collaborator
Tiofarma
Collaborator
Dutch Arthritis Foundation Reuma Nederland
Collaborator
Source ClinicalTrials.gov