Abstract
BackgroundThe 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.MethodsSeventy 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.ResultsPatients 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 %).ConclusionThis 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 registrationID ISRCTN63795830. The trial was retrospectively registered on 2 October, 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12891-016-1268-4) contains supplementary material, which is available to authorized users.
Highlights
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
Patients responding to inclusion/exclusion criteria and considered by the physician as requiring a 6-month treatment of chondroitin sulfate (800 mg/day; Condrosan®, Bioiberica S.A., Spain) in accordance with the daily clinical practice were selected for the study
Population characteristics Seventy two (72) unilateral symptomatic knee OA patients were selected for this study: 64 patients were included in the analysis of the safety population (SEP), 61 for the ITT population and 59 for the PP population
Summary
The aim of this study was to investigate the effects of chondroitin sulfate (CS) on the serum levels of Coll in patients with knee OA. The challenge for the last decades has been to find a cure for OA and to identify tools which could help the diagnosis and monitoring disease progression and efficacy of therapeutic interventions. Those tools need to be accurate for the monitoring of structural progression of the disease and sensitive enough to identify early event at the molecular level. They could be valuable tool in the new era of personalized medicine
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