Hip Osteoarthritis
Conditions
Keywords
Diacerein, Hip osteoarthritis, Structure-modifying effect / Chondromodulating effect, Double blind study
Brief summary
We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to: * evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis * to investigate the potential structure-modifying effect of diacerein in patients with hip osteoarthritis This study compare also after ten years the percentage of patients in each treatment group who require a hip replacement surgery
Interventions
DRUGdiacerein
Sponsors
Laboratoires NEGMA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Outpatients fulfilling the American College of Rheumatology criteria for the diagnosis of hip osteoarthritis. * Lequesne algofunctional index of at list 3 points. * Radiographic criterion for inclusion: joint space width (JSW) between 1 mm and 3 mm. If the JSW exceeded 3 mm, it had to be at least 0.5 mm thinner than JSW of the contra lateral hip, measured at its narrowest point.
Exclusion criteria
* Intraarticular injection or arthroscopy of the hip during the three months prior to inclusion in the study. * Any systemic or intraarticular corticosteroid as well as other potential symptom-modifying drugs for osteoarthritis were not allowed during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint space measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| Requirement of hip replacement surgery after ten years | — |
| Tolerability | — |
Countries
France
Outcome results
None listed