Evaluating colchicine's effect on knee and hip replacements in osteoarthritis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess whether daily treatment with colchicine can reduce the incidence of knee or hip replacements in patients diagnosed with osteoarthritis. Participants will take colchicine or a placebo for a duration of 3 to 4.5 years, with regular clinic visits for check-ups, blood tests, and x-rays. The study will compare the outcomes of those receiving colchicine against those receiving a placebo to determine its effectiveness in managing osteoarthritis symptoms and preventing surgical interventions.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

* 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, tipranavir, atazanavir, darunavir, indinavir, saquinavir, and cobicistat), anti-arrhythmic drugs (i.e. verapamil, diltiazem), or immunosuppressant (i.e. cyclosporine)
* 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

Where it's running

• Sint Maartenskliniek
  Nijmegen, Netherlands Recruiting

Study contacts

• Study coordinator: Tim Massa
• Email: t.massa@maartenskliniek.nl
• Phone: +31633036353

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing barbed and conventional wound closure after hip or knee replacement

  This study will test whether barbed sutures or conventional sutures lead to better wound healing and fewer complications for adults having primary or aseptic revision hip or knee replacement.

  Recruiting Umraniye Education and Research Hospital · Istanbul, Istanbul · NCT07439575

• Personalized rehabilitation care for joint replacement patients

  This study is testing whether an AI tool can help create personalized rehab plans for people recovering from hip and knee joint replacement surgeries.

  Recruiting I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Milan, Italia · NCT06249958

• Improving sleep to reduce pain after joint surgery

  This study is testing if helping people with insomnia sleep better before knee or hip surgery can reduce their pain after the operation.

  Recruiting Uppsala University · Uppsala, Uppland · NCT06145516

• Helping osteoarthritis patients walk with NSAIDs

  This study is testing a new program that combines special exercises and occasional use of pain relief medications to help people with hip or knee osteoarthritis walk better.

  Recruiting Phase 4 University Hospital, Clermont-Ferrand · Clermont-Ferrand · NCT05761015

• Targeting abnormal blood flow to treat chronic joint pain in veterans

  This study is testing if treating abnormal blood flow in the joints can help veterans with chronic pain and osteoarthritis feel better.

  Recruiting Palo Alto Veterans Institute for Research · Palo Alto, California · NCT05700682

• Low-impact exercise program for joint pain relief

  This study is testing if joining low-impact exercise classes can help people with knee, hip, and ankle pain from osteoarthritis feel better and move easier.

  Recruiting University of Missouri-Columbia · Columbia, Missouri · NCT03711773

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.