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01.12.2016 | Research article | Ausgabe 1/2016 Open Access

BMC Musculoskeletal Disorders 1/2016

Effect of chondroitin sulfate on soluble biomarkers of osteoarthritis: a method to analyze and interpret the results from an open-label trial in unilateral knee osteoarthritis patients

Zeitschrift:
BMC Musculoskeletal Disorders > Ausgabe 1/2016
Autoren:
Ingrid Möller, Myriam Gharbi, Helena Martinez Serrano, Marta Herrero Barbero, Josep Verges Milano, Yves Henrotin
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s12891-016-1268-4) contains supplementary material, which is available to authorized users.

Abstract

Background

The aim of this study was to investigate the effects of chondroitin sulfate (CS) on the serum levels of Coll2-1 in patients with knee OA.

Methods

Seventy two patients with unilateral symptomatic knee OA were involved in a post-authorization open-label study evaluating CS (800 mg/day). The primary outcome was the % relative change in serum Coll2-1 (sColl2-1). The secondary outcomes were the evaluation of pain (VAS) and function (Lequesne’s Index). Responders and non-responders were classified according to OMERACT-OARSI recommendations. Finally, an original cut-off method was applied to categorize patients and interpret individual variations in serum levels of Coll2-1.

Results

Patients showed no difference in the sColl2-1 levels at baseline. When considering responders and non-responders from the ITT population, a significant difference was found for Coll2-1 at 3 months (p = 0.030) and 6 months (p = 0.038). A decrease in pain (VAS) and an improvement in function (LI) were recorded throughout the visits (p < 0.01). Considering an intra-batch cut-off of 21 %, CS decreased Coll2-1 serum levels between baseline and 1-month visit compared to the value of Coll2-1 before treatment (screening visit) which can be interpreted as a drastic reduction of the proportion of patients with an increase of Coll2-1 over 21 % (reduction from 13 to 3 %). It also consisted in a more important proportion of patients with a decrease in Coll2-1 (from 5 to 10 %).

Conclusion

This study proposes a new approach for the analysis and the interpretation of the individual variation in biomarker levels and introduces the notion of metabolic responders.

Trial registration

ID ISRCTN63795830. The trial was retrospectively registered on 2 October, 2015.
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