Study of the Effect of Chondroitin Sulfate on Structural Changes in Knee Osteoarthritis Patients Assessed by MRI

Bioiberica194 enrolled

Overview

The main purpose of this study is to compare the cartilage volume loss at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.

To compare long term disease modifiying and symptomatic effects at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

194

Conditions

Knee Osteoarthritis

Interventions

Chondroitin sulfateDRUG

Chondroitin sulphate 1200 mg/day, 24 months treatment period

CelecoxibDRUG

Celecoxib 200 mg/day, 24 months treatment period

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals of either sex, aged 40 years and more * Subjects presenting primary OA of the knee according to ACR criteria with signs of synovitis (warmth, swelling or effusion * OA of radiological stages 2 and 3 according to Kellgren-Lawrence; * Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray * VAS of pain while walking ≥ 40 mm Exclusion Criteria: * Known allergy to CHONDROITIN SULPHATE, hypersensitivity to CELECOXIB, demonstrated allergic-type reactions to sulphonamides, experienced asthma, urticaria or allergic-type reactions after taking sulphonamides, aspirin (acetyl salicylic acid \[ASA\]), lactose or NSAIDs * Active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma * Increased risk for prostate cancer, with prostate cancer, or with a history of prostate cancer within the last five years * Subjects with other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease * Isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only * Class IV functional capacity using the American Rheumatism Association criteria * Have had surgery in any lower limb or arthroscopy, aspiration or lavage in any lower limb joint within 180 days of the Baseline Visit * History of heart attack or stroke, or experienced serious chest pain related to heart disease, or who have had serious diseases of the heart such as congestive heart failure * High risk of CV events, according to the AHA assessment of CV risk tables * History of recurrent UGI ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect, or any other condition, which in the investigator's opinion might preclude the chronic use of CELECOXIB. Subjects may, at the Investigator's discretion, take a PPI or antacids daily as required * Have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication * Subjects using corticosteroids (oral, injectable; exception of intraarticular/soft tissue injection at the exclusion of the target knee), indomethacin, tramadol, codeine, empracet, therapeutic dose of glucosamine or CHONDROITIN SULPHATE during the 12 weeks preceding inclusion * Using hyaluronic acid (intra-articular target knee) during the 26 weeks preceding inclusion * Using Natural Health Products (e.g. capsaicin, boswellia, willow bark), and creams and analgesic gels (e.g. camphor and alcohol based gels) during one week preceding baseline; * Using Natural Health Products susceptible to increase the risk of bleeding (e.g. garlic, dong quai, etc.) during one week preceding baseline; * Receiving radioactive synovectomy (target knee) during the 12 weeks preceding inclusion; * Subjects who are receiving NSAID and do not want to stop during the study * If treatment of osteoporosis (biphosphonates, SERMS, THS) is necessary, it will have to be continued, unmodified, for the entire duration of the study * Have used medications with MMP-inhibitory properties (e.g. tetracycline or structurally related compounds) within 28 days prior to the Baseline Visit * Are taking lithium carbonate, phenytoin or anticoagulants (with the exception of ASA up to a maximum daily dose of 325 mg) * Have received chondrocyte transplants in any lower extremity joint * Use oral or topical COXIBs, calcitonin or immunosuppressive drugs

Locations (5)

Institut de Rhumatologie de Montréal

Montreal, Quebec, Canada

Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM)

Montreal, Quebec, Canada

Groupe de Recherche en rhumatologie et maladies osseoues

Québec, Quebec, Canada

Centre de Rhumatologie St. Louis

Sante Foi, Quebec, Canada

Outcomes

Primary Outcomes

Cartilage Volume Loss of the Lateral Compartment

To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 12 and 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily.

Time frame: 12 months (Day 364) and 24 months (Day 728)

Secondary Outcomes

Cartilage Volume Loss of the Global Knee

To compare the cartilage volume loss of the global knee at the Baseline visit and after 12 and 24 months.

Time frame: 12 months (Day 364) and 24 months (Day 728)

Cartilage Volume in the Medial Compartment

To compare the cartilage volume loss of the medial compartment at the Baseline visit and after 12 and 24 months.

Time frame: 12 months (Day 364) and 24 months (Day 728)

Synovial Membrane Thickness

To compare the severity of synovitis score (Thickness of the Synovial Membrane in mm) in Global Knee , at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB. The severity of synovitis was evaluated through four regions of interest (ROIs) in the images of the axial T1-weighted acquisition complemented with the use of the images of the axial T2-weighted acquisition. The thickness of the synovial membrane was evaluated in the global knee and each of the ROIs and results were expressed in millimetres. The four ROIs were the proximal lateral, distal lateral, proximal medial and distal medial.

Time frame: Baseline, 12 months (Day 364) and 24 months (Day 728)

Bone Marrow Lesions Score

To compare the bone marrow lesions (BMLs) score in the global knee and the different sub regions at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB. The BMLs were assessed in the global knee and the different sub region of the knee (medial trochlea, plateau of the medial femoro-tibial joint, femur of the medial femoro-tibial joint, medial posterior condyle, lateral trochlea, plateau of the lateral femoro-tibial joint, femur of the lateral femoro-tibial joint, lateral posterior femur). The BMLs score was defined as a grade (between 0 and 3) in each knee sub region and summed to derive a global knee score ranging between 0 (absent) and 30 (present). Specifically, each grade was scored as follows: * Grade 0 = Absence of lesion in the sub region * Grade 1 = less than 25% of the surface * Grade 2 = 25-50% of the surface * Grade 3 = more than 50% of the surface

Data from ClinicalTrials.gov

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