Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

Osteoarthritis Clinical Trial

Official title:

Study of the Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604539
• Other study ID #: CS/IV-SIN-01
• Secondary ID: CS/IV-SIN-01
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2008
• Last updated: December 16, 2011
• Start date: February 2008

Study information

• Verified date: December 2011
• Source: Bioiberica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of a chondroitin sulphate conventional treatment on the degree of severity of synovitis, as measured by magnetic resonance in patients with knee OA with clinical synovitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Primary OA of the knee according to ACR with synovitis criteria (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;

• Progressive or serious pathologies (cancer, AIDS,...);

• Other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis;

• Corticosteroids (oral, injectable), indomethacin, therapeutic dose of glucosamine or chondroitin sulphate during the 12 weeks preceding inclusion;

• Hyaluronic Acid (intra-articular pathway) during the 26 weeks preceding inclusion;

• Radioactive synovectomy during the 12 weeks preceding inclusion;

• If the patient is receiving NSAID at baseline (D0), it should be maintained at a stable dosage as much as possible from D0 to D180. In the open phase of the study (D180 to D360), NSAID will also be allowed as rescue medication along with acetaminophen.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Muskuloskeletal Diseases
• Osteoarthritis
• Osteoarthritis, Knee
• Synovitis

Intervention

Drug:
• Chondroitin sulphate (Condrosan)
800 mg (two capsules of 400 mg each) taken once a day for one year
• Placebo
Two placebo capsules taken once a day for six months followed by an additional six month treatment of 800 mg (two capsules of 400 mg of Chondroitin sulphate each) taken once a day

Locations

Country	Name	City	State
Canada	Inst. De Rhumatologie	Montréal	Quebec
Canada	Centre de rhumatologie St-Louis	Ste-Foy	Quebec
Canada	Groupe de recherche en rhumatologie et maladies osseuses	Ste-Foy	Quebec
Canada	Centre de recherche musculo-squelettique	Trois-Rivieres	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Bioiberica

Country where clinical trial is conducted

Canada, 

References & Publications (14)

Berthiaume MJ, Raynauld JP, Martel-Pelletier J, Labonté F, Beaudoin G, Bloch DA, Choquette D, Haraoui B, Altman RD, Hochberg M, Meyer JM, Cline GA, Pelletier JP. Meniscal tear and extrusion are strongly associated with progression of symptomatic knee osteoarthritis as assessed by quantitative magnetic resonance imaging. Ann Rheum Dis. 2005 Apr;64(4):556-63. Epub 2004 Sep 16. — View Citation

Clegg DO, Reda DJ, Harris CL, Klein MA, O'Dell JR, Hooper MM, Bradley JD, Bingham CO 3rd, Weisman MH, Jackson CG, Lane NE, Cush JJ, Moreland LW, Schumacher HR Jr, Oddis CV, Wolfe F, Molitor JA, Yocum DE, Schnitzer TJ, Furst DE, Sawitzke AD, Shi H, Brandt KD, Moskowitz RW, Williams HJ. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med. 2006 Feb 23;354(8):795-808. — View Citation

Fajardo M, Di Cesare PE. Disease-modifying therapies for osteoarthritis : current status. Drugs Aging. 2005;22(2):141-61. Review. — View Citation

Hochberg MC, Altman RD, Brandt KD, Clark BM, Dieppe PA, Griffin MR, Moskowitz RW, Schnitzer TJ. Guidelines for the medical management of osteoarthritis. Part II. Osteoarthritis of the knee. American College of Rheumatology. Arthritis Rheum. 1995 Nov;38(11):1541-6. — View Citation

Leeb BF, Schweitzer H, Montag K, Smolen JS. A metaanalysis of chondroitin sulfate in the treatment of osteoarthritis. J Rheumatol. 2000 Jan;27(1):205-11. — View Citation

Loeuille D, Chary-Valckenaere I, Champigneulle J, Rat AC, Toussaint F, Pinzano-Watrin A, Goebel JC, Mainard D, Blum A, Pourel J, Netter P, Gillet P. Macroscopic and microscopic features of synovial membrane inflammation in the osteoarthritic knee: correlating magnetic resonance imaging findings with disease severity. Arthritis Rheum. 2005 Nov;52(11):3492-501. — View Citation

McAlindon TE, LaValley MP, Gulin JP, Felson DT. Glucosamine and chondroitin for treatment of osteoarthritis: a systematic quality assessment and meta-analysis. JAMA. 2000 Mar 15;283(11):1469-75. Review. — View Citation

Michel BA, Stucki G, Frey D, De Vathaire F, Vignon E, Bruehlmann P, Uebelhart D. Chondroitins 4 and 6 sulfate in osteoarthritis of the knee: a randomized, controlled trial. Arthritis Rheum. 2005 Mar;52(3):779-86. — View Citation

Morreale P, Manopulo R, Galati M, Boccanera L, Saponati G, Bocchi L. Comparison of the antiinflammatory efficacy of chondroitin sulfate and diclofenac sodium in patients with knee osteoarthritis. J Rheumatol. 1996 Aug;23(8):1385-91. — View Citation

Raynauld JP, Martel-Pelletier J, Berthiaume MJ, Beaudoin G, Choquette D, Haraoui B, Tannenbaum H, Meyer JM, Beary JF, Cline GA, Pelletier JP. Long term evaluation of disease progression through the quantitative magnetic resonance imaging of symptomatic knee osteoarthritis patients: correlation with clinical symptoms and radiographic changes. Arthritis Res Ther. 2006;8(1):R21. Epub 2005 Dec 30. — View Citation

Richy F, Bruyere O, Ethgen O, Cucherat M, Henrotin Y, Reginster JY. Structural and symptomatic efficacy of glucosamine and chondroitin in knee osteoarthritis: a comprehensive meta-analysis. Arch Intern Med. 2003 Jul 14;163(13):1514-22. — View Citation

Uebelhart D, Malaise M, Marcolongo R, de Vathaire F, Piperno M, Mailleux E, Fioravanti A, Matoso L, Vignon E. Intermittent treatment of knee osteoarthritis with oral chondroitin sulfate: a one-year, randomized, double-blind, multicenter study versus placebo. Osteoarthritis Cartilage. 2004 Apr;12(4):269-76. Erratum in: Osteoarthritis Cartilage. 2007 Aug;15(8):979. DeVathaire, Florent [corrected to de Vathaire, Florent]. — View Citation

Wildi LM, Raynauld JP, Martel-Pelletier J, Beaulieu A, Bessette L, Morin F, Abram F, Dorais M, Pelletier JP. Chondroitin sulphate reduces both cartilage volume loss and bone marrow lesions in knee osteoarthritis patients starting as early as 6 months afte — View Citation

Zhang W, Doherty M, Arden N, Bannwarth B, Bijlsma J, Gunther KP, Hauselmann HJ, Herrero-Beaumont G, Jordan K, Kaklamanis P, Leeb B, Lequesne M, Lohmander S, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Swoboda B, Varatojo R, Verbruggen G, Zimmermann-Gorska I, Dougados M; EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). EULAR evidence based recommendations for the management of hip osteoarthritis: report of a task force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis. 2005 May;64(5):669-81. Epub 2004 Oct 7. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the change in the severity of synovitis measured by MRI according to the modified methods of Loeuille et al. after chondroitin sulphate treatment in patients with knee OA and clinical signs of synovitis		One year	No
Secondary	Changes of cartilage volume and subchondral bone lesions		One year	No
Secondary	Pain measured by VAS		One year	No
Secondary	WOMAC index		One year	No
Secondary	SF-36 Health Questionaire		One year	No
Secondary	Assessment of joint swelling, effusion		One year	No
Secondary	Use of rescue medication		One year	No
Secondary	Tolerability		One year	Yes
Secondary	Adverse events		One year	Yes