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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Colchicine
Drug
Colchicine 0.5mg tablets once a day for 3 to 4.5 years
Placebo
Drug
Placebo tablets once a day for 3 to 4.5 years

Treatment groups

1,410 Participants

are divided into 2 treatment groups

Group A: ColchicineExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to first knee or hip replacement

Time frame

From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years

Secondary outcomes

1

Course of pain as assessed by NRS (numeric rating scale)

The 11-point NRS ranges from '0' ("no pain") to '10' ("worst pain imaginable")

Time frame

From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years

2

Course of pain as assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index)

5 items are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores indicate more pain

Time frame

From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years

3

Course of physical function as assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index)

17 items are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). Higher scores indicate more functional limitations

Time frame

From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years

4

Course of joint space narrowing on X-ray

Time frame

From baseline until the date of first documented knee or hip replacement or study end, whichever comes first, assessed up to 4.5 years

Other outcomes

1

The number of (serious) adverse events

Adverse events are defined as any untoward medical occurrence in a subject to whom a medicinal product is administered, and which does not necessarily have a causal relationship with this treatment. Serious adverse event is any untoward medical occurrence in a patient or trial subject that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect

Time frame

From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years

2

The number of withdrawals due to (serious) adverse events

Adverse events are defined as any untoward medical occurrence in a subject to whom a medicinal product is administered, and which does not necessarily have a causal relationship with this treatment. Serious adverse event is any untoward medical occurrence in a patient or trial subject that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect

Time frame

From randomization until the date of first documented knee or hip replacement, date of death, date of lost to follow-up, or study end-date, whichever comes first, assessed up to 4.5 years

3

Changes in laboratory data (i.e. serum creatinine, estimated glomerular filtration rate, and alanine transferase)

Time frame

At enrolment, at baseline, 1 year thereafter, and at study completion (approximately 4.5 years)

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts