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

NCT06578182 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1410

Last updated 2025-02-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • RSMK

    collaborator UNKNOWN

  • Tiofarma

    collaborator UNKNOWN

  • Dutch Arthritis Foundation Reuma Nederland

    collaborator UNKNOWN

  • Sint Maartenskliniek

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06578182 on ClinicalTrials.gov