Efficacy and Safety of Prednisolone and Chloroquine Add on Therapy in Osteoarthritis of the Knee

Phase 4

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: Glucosamine and chondroitin sulfate; Drug: glucosamine and chondroitin sulfate plus Prednisolone; Drug: Glucosamine and Chondroitin sulfate plus Chloroquine; Drug: Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine

• Registration Number: NCT00805519
• Lead Sponsor: Ardabil University of Medical Sciences

Brief Summary

This study was conducted to evaluate the efficacy and safety of prednisolone and chloroquine add on therapies to combined glucosamine, chondroitin sulfate in osteoarthritis of the knee which will be done in contrast to combined glucosamine sulfate and chondroitin.

Detailed Description

Fixed dose glucosamine, chondroitin sulfate combination is a treatment to osteoarthritis with some controversy about efficacy. it seems that addition of other agents may improve efficacy and decrease the required dose and cost. common oral corticosteroids such as low dose prednisolone and chloroquine are candidate for such add on therapies. nevertheless, add on therapy may expose the patients to new side effects which should followed and addressed.

In this investigator blinded controlled trial, 240 patients with diagnosed osteoarthritis of knee will be enrolled to the study. the patients will randomly be assigned to one of four groups of G (glucosamine and chondroitin sulfate ), P (Glucosamine and Chondroitin sulfate plus Prednisolone), C (Glucosamine and Chondroitin sulfate plus Chloroquine) and PC (Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine). each group will consist 60 patients. the investigator(s) will be blind to the groups and interventions.

Study Timeline

• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Study Start: 2009-02
• Status Verified: 2010-04
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2010-04-29
• Last Update Posted: 2010-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• men and non-pregnant women, age 40-85 years with primary OA of at least one knee.

Exclusion Criteria

• secondary arthritis related to systemic inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis, post-infectious arthritis and metabolic arthritis, traumatic arthritis or surgical joint replacement)corticosteroid use:

  • oral corticosteroid within the previous 14 days
  • intramuscular corticosteroid within 30 days
  • intraarticular corticosteroid into the study knee within 90 days
  • intra-articular corticosteroid into any other joint within 30 days or
  • topical corticosteroid at the site of application within 14 days

• ongoing use of prohibited medication including NSAID, other oral analgesic, muscle relaxant, or low-dose antidepressant for any chronic pain management

• glucosamine or chondroitin within the previous six months

• history of alcohol or drug abuse

• lactation

• concomitant skin disease at the application site

• current application for disability benefits on the basis of knee osteoarthritis; fibromyalgia; other painful or disabling condition affecting the knee

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucosamine and chondroitin sulfate	Glucosamine and chondroitin sulfate	in this group patients will receive Glucosamine and chondroitin sulfate oral dietary supplementation
P :glucosa, chondroitin, Prednis	glucosamine and chondroitin sulfate plus Prednisolone	in this group patients will receive glucosamine and chondroitin sulfate plus Prednisolone oral administration
Glucosa, Chondroitin, Chloroquine	Glucosamine and Chondroitin sulfate plus Chloroquine	in this group pateints will orally receive Glucosamine and Chondroitin sulfate plus Chloroquine.
Glucosa, Chondro, Prednis,Chloroq	Glucosamine,Chondroitin sulfate,Prednisolone,Chloroquine	in this group patients will receive Glucosamine and Chondroitin sulfate plus Prednisolone and Chloroquine

Primary Outcome Measures

Name	Time	Method
The primary outcome measures is defined as the change from baseline to final assessment of the study knee in the 3 core continuous variables pain and physical function, assessing using the WOMAC subscales, and patient global assessment (PGA)	the outcome is assessed at 12 weeks after baseline visit

Secondary Outcome Measures

Name	Time	Method
The secondary measure will be changes in stiffness	the outcome is assessed at 12 weeks after baseline visit

Trial Locations

Locations (1)

ArdabiUMS Clinic of Rheumatology; 🇮🇷 Ardabil, Iran, Islamic Republic of