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Effect of 12 months treatment with chondroitin sulfate on cartilage volume in knee osteoarthritis patients: a randomized, double-blind, placebo-controlled pilot study using MRI

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An Erratum to this article was published on 20 June 2014

Abstract

This pilot study aimed to evaluate the correlation between clinical symptoms and cartilage volume through MRI in patients with knee osteoarthritis after 48 weeks of treatment with Structum®. Multicenter, double-blind, placebo-controlled, parallel-group study. Symptomatic knee osteoarthritis patients aged 50–75 years received either Structum® (500 mg twice daily; N = 22) or placebo (N = 21) during 48 weeks. Inclusion criteria were global pain in the target knee ≥30 mm (VAS 0–100) and radiological Kellgren-Lawrence grade 2 or 3. Clinical assessments included Lequesne index and VAS for pain on motion, at baseline, 24 and 48 weeks, and MRI at baseline and at 24 and 48 weeks. Global and compartments cartilage volume, joint cartilage abnormalities, meniscal lesions, ligaments abnormalities, synovitis, synovial effusion, osteophytes, subchondral cysts, popliteal cysts and subchondral oedema were quantified. The quantitative and qualitative reproducibility of MRI was tested by the Spearman correlation coefficient and kappa coefficients, respectively. Treatments were compared by an analysis of covariance with baseline value as covariate. Groups were comparable at baseline for demographics, disease characteristics, and cartilage volumes. A significant inter-readers correlation was seen for the assessment of cartilage volumes, number of cysts, and osteophytes (correlation coefficients from 0.951 to 0.980 within investigator and from 0.714 to 0.957). After 48 weeks, symptoms improved in both groups. The total cartilage volume increased in the Structum® group (+180 mm3 + SD) which opposed to a loss in the placebo (−46 mm3 + SD; NS). No statistically significant differences between groups were observed for the other MRI parameters. No correlations were evidenced between key MRI parameters changes and symptoms. The difference in the evolution of cartilage volume between the two groups could reflect a structure modifying effect of Structum®. This pilot study confirms the usefulness of quantitative and qualitative MRI as a sensitive tool to assess a structure modifying drugs in knee osteoarthritis.

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Abbreviations

3-D:

Three-dimensional

ACR:

The American College of Rheumatology

AE:

Adverse event

BMI:

Body mass index

JSW:

Joint space width

KOA:

Knee osteoarthritis

MedDRA:

Medical dictionary for regulatory activities

MRI:

Magnetic resonance imaging

NSAID:

Non-steroidal anti-inflammatory drugs

OA:

Osteoarthritis

SD:

Standard deviation

SYSADOA:

Symptomatic slow-acting drugs for OA

TEAE:

Treatment-emergent adverse event

VAS:

Visual analog scale

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Acknowledgements

We gratefully acknowledge the contribution of Mrs. Anne Maret for the global coordination of this study. We thank Mrs. Nicole Caujolle for her excellent administrative support.

We also wish to acknowledge Mr. Michel Hucher (Pierre Fabre Biométrie—Labège—France) who provided statistical review for the study.

Institut de Recherche Pierre Fabre provided financial and material support for the design and concept of the study, data collection, data-management, data analysis, and medical writing services of this study.

The authors thank Dr. Alain Platel and his colleagues at APMW for help provided with the manuscript.

Competing interests

Prof. JJ Railhac and Prof. B Fournié received research grants for this study by Institut de Recherche Pierre Fabre.

Dr. M. Zaim and Ms A-S Saurel are employees of Institut de Recherche Pierre Fabre who sponsored the trial.

Authors' contributions

Prof. J.J. Railhac, Dr. M. Zaim, Ms. A.-S. Saurel, Dr. J Vial and Prof. B. Fournié have substantially contributed to conception and design, acquisition, analysis, and interpretation of the study data. They have reviewed and approved the manuscript.

Disclosures

None.

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Authors and Affiliations

  1. Service Central de Radiologie et d’Imagerie Médicale, Hôpital Purpan, 1 place du Docteur Baylac, 31059, Toulouse Cedex, France

    J-J. Railhac & J. Vial

  2. IRPF—Pierre Fabre Innovation, 3 Avenue Hubert Curien, 31035, Toulouse Cedex 1, France

    M. Zaim

  3. IRPF—CDPF, 3 Avenue Hubert Curien, 31035, Toulouse Cedex 1, France

    A-S. Saurel

  4. Service de Rhumatologie, Hôpital Purpan, 1 place du Docteur Baylac, 31059, Toulouse Cedex, France

    B. Fournie

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  1. J-J. Railhac
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  2. M. Zaim
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  3. A-S. Saurel
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  4. J. Vial
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  5. B. Fournie
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Corresponding author

Correspondence to M. Zaim.

Additional information

Registration

ISRCTN33423639—http://www.controlled-trials.com/ISECTN33423639

An erratum to this article is available at http://dx.doi.org/10.1007/s10067-014-2724-x.

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Railhac, JJ., Zaim, M., Saurel, AS. et al. Effect of 12 months treatment with chondroitin sulfate on cartilage volume in knee osteoarthritis patients: a randomized, double-blind, placebo-controlled pilot study using MRI. Clin Rheumatol 31, 1347–1357 (2012). https://doi.org/10.1007/s10067-012-2022-4

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  • DOI: https://doi.org/10.1007/s10067-012-2022-4

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