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New treatment option for Osteoarthritis, Knee
Official title The Effect of ColcHicine on the Incidence of Knee or Hip Replacements
ClinicalTrials.gov ID: NCT06578182
What this study is testing
What is Colchicine?
Colchicine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for osteoarthritis, knee.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80
You may be able to join if
- 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...
- documented radiographic changes typical for advanced knee/hip OA (Kellgren \& Lawrence score ≥ 2), or at least 2-year history of complaints due to OA...
You likely can't join if
- 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
- Known generalized pain syndromes such as fibromyalgia
- Renal impairment as evidenced by serum creatinine \>150µmol/l or estimated glomerular filtration rate (eGFR) \<50mL/min/1.73m2
See the full eligibility criteria
- 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
- 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
- Known generalized pain syndromes such as fibromyalgia
- Renal impairment as evidenced by serum creatinine \>150µmol/l or estimated glomerular filtration rate (eGFR) \<50mL/min/1.73m2
- Liver function impairment as evidenced by serum alanine transferase (ALAT) \> 3 ULN (upper limit of normal)
- Blood dyscrasia
- High frailty (clinical frailty scale ≥ 7) or predicted life expectancy \< 5 years
- Peripheral neuritis, myositis or marked myo-sensitivity 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, itraconazole and voriconazole), protease inhibitors \& anti-retroviral drugs (i.e. ritonavir, lopinavir...
- Current enrollment in another trial
- Incapacitated patients
- Pregnant or breastfeeding female
- Fertile female participants not taking sufficient anti-conception
- Male participants unwilling to use effective contraception during the study to prevent pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Nijmegen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nijmegen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.