Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a very frequent affection of the elderly and causes very painful arthritis. International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence. The treatment of CPPD arthritis is extrapolated from the experience of gout treatment, another crystal deposition disease. Among recommended treatments, colchicine and oral steroids are recommended as first-line treatments, while NSAIDs are used with caution in elderly populations of patients. Colchicine utilization is not risk-free, in particular with old patients and patients with renal impairment. Drug interactions of colchicine can have serious consequences, especially in a polymedicated old patient's population. Oral steroids are an interesting alternative in this indication with a potential of being better tolerated, but comparative efficacy with colchicine needs to be studied. From a broader point of view, colchicine and oral steroids have never been compared in any crystal related arthritis. This is the first large randomized controlled trial for CPPD acute arthritis.
Chondrocalcinosis, recently renamed the calcium pyrophosphate deposition (CPPD) disease, is a very frequent affection of the elderly and causes very painful arthritis. International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence. Some factors are known to trigger CPPD arthritis (trauma, surgery, infection, hospitalization). Prevalence increases with age, and case series estimate the presence of chondrocalcinosis in over 20% of 80 plus years population. International recommendations for the treatment of patients suffering from CPPD are based upon rare studies, not randomized, with small samples, and thus very weak scientific evidence. The treatment of CPPD arthritis is extrapolated from the experience of gout treatment, another crystal deposition disease (this one related to monosodium urate crystals that deposit after long-standing hyperuricemia. Among recommended treatments, colchicine and oral steroids are recommended as first-line treatments, while NSAIDs are used with caution in elderly populations of patients. Colchicine utilization is not risk-free, in particular with old patients and patients with renal impairment. Drug interactions of colchicine can have serious consequences, especially in a polymedicated old patient's population. Oral steroids offer an interesting alternative with the potential of being better tolerated. However, even oral steroids are recommended, their efficacy in CPPD arthritis isn't demonstrated. Interesting comparative results with NSAIDs were shown for the treatment of gout flares. These results may not be fully extrapolated to CPPD which holds differences with gout. In addition, oral steroids were not compared to colchicine which is the benchmark treatment in many countries for CPPD. The aim of this study is to compare the efficacy of colchicine and oral steroids for the treatment of CPPD acute arthritis and compare their tolerance profile. It is the first large randomized controlled trial comparing two treatments of CPPD acute arthritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
111
International non-proprietary name: Colchicine Molecule owner: Mayoly-Spindler Laboratory, 1mg scored tablet for oral administration, authorized 03/02/1995. Composition : Active principle : Crystallized colchicine Excipients: Erythrosine aluminium lake, lactose, saccharose, magnesium stearate and povidone.
International non-proprietary name: Prednisone Molecule owner : SANOFI AVENTIS France 20 mg scored tablet for oral administration, authorized since 02/05/1990, generic drug available. Composition : Active principle : Prednisone Excipients: Maize starch, lactose, talc, magnesium stearate.
CHRU Lille
Lille, Hauts-de-France, France
Lille Catholic Hospital
Lille, Hauts-de-France, France
CH Valenciennes
Valenciennes, Hauts-de-France, France
Dr Nicolas SEGAUD
Armentières, France
Dr Rémi LEROY
Dunkirk, France
Hôpital de Lariboisière
Paris, Île-de-France Region, France
Hôpital Bichat
Paris, Île-de-France Region, France
Change from baseline in the pain VAS at 24 hours
Evolution of the pain Visual Analog Scale (VAS), between baseline and 24 hours after the first treatment administration, without any recourse to other anti-inflammatory treatments.
Time frame: From the first treatment administration to 24 hours after.
Proportion of patients with at least one adverse event within 48 hours
Proportion of patients with at least one adverse event within 48 hours following the first drug intake (diarrhea, abdominal pain, nausea, vomiting, a 50% fasting blood glucose increase, excitability, sleep disorders, high blood pressure apparition \[above 140/90mmHg\], change in creatinine clearance)
Time frame: 48 hours following the first administration
Change from baseline of biological inflammatory syndrome at 48 hours
C Reactive Protein change from baseline 48 hours after the first treatment intake.
Time frame: From the first treatment administration to 48 hours after.
Number of joints affected and their localizations
Number of affected articulations and their localization before the first intake, after 24 hours and after 48 hours.
Time frame: Before, 24 hours and 48 hours after the first administration
Need of emergency morphinic treatment
Proportion of patients requiring analgesia with morphine within the first 24 hours.
Time frame: 24 hours after the first administration
Analgesic consumption
Proportion of patients requiring additional analgesics between the 24th and 48th hour following the 1st intake.
Time frame: From 24 hours to 48 hours after the first treatment administration
Proportion of patients with an efficacy response of at least 50%
Proportion of patients with at least a 50% decrease in pain VAS at 24 and 48 hours after the first intake.
Time frame: 24 hours and 48 hours after the first administration.
Proportion of patients with an efficacy response of at least 20%
Proportion of patients with at least a 20% decrease in pain VAS at 8, 12 and 24 hours after the first administration.
Time frame: 8, 12 and 24 hours after the first administration.
Complete crisis resolution within 7 days
Proportion of patient with a complete resolution of the arthritis within the 7 days after 1st intake (defined by a ≤3/10 VAS score)
Time frame: 7 days after 1st administration
Initial crisis resolution delay
Delay to the complete resolution of the arthritis from the first drug intake
Time frame: 7 days after 1st administration
Absence of crisis recidivism within 7 days
Relapse rate within the 7 days following the 1st intake (defined by the recurrence of pain with a \>3/10 VAS score)
Time frame: Within the 7 days following the 1st administration
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