Determination of serum biomarkers in osteoarthritis patients: a previous interventional imaging study revisited

Abstract

To evaluate in an interventional trial on knee osteoarthritis (OA) the level and change of two serum biomarkers and their correlation with imaging parameters. The previously reported interventional OA study (ClinicalTrials.gov: NCT00536302) identified a positive effect of collagen hydrolysate (CH) on cartilage morphology in patients with knee OA using delayed gadolinium enhanced magnetic resonance imaging (dGEMRIC). It was the objective in this research project to evaluate in an interventional clinical trial on knee OA the level and change of two serum biomarkers and their correlation with imaging parameters. In blood samples of study participants, we determined the concentration of procollagen type II N-terminal propeptide (PIIANP) and aggrecan chondroitin sulfate 846 epitope (CS846) at baseline (BL) and at the follow-up (FU) visits at 24 and 48 weeks. We measured the level and change of biomarker concentrations in both study groups, and the correlation of those changes with changes in dGEMRIC. For the biomarker PIIANP, we observed a significantly greater increase in the CH group (29.9% vs. 1.2% at week 24, P= 0.001). For CS846, the mean concentration was lower among the CH treated participants at 24 weeks (78% vs. 96%, P= 0.045). Consistent correlations of changes in biomarkers PIIANP and CS846 with changes of the dGEMRIC score could not be observed. In this study, different changes per treatment group, CH and placebo were seen for dGEMRIC and PIIANP BL to 24 weeks FU, but only weak correlations between changes in dGEMRIC and biochemical markers.

Keywords

knee osteoarthritis / interventional trial / magnetic resonance imaging / serum chemical biomarkers

References

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Acknowledgments

The original interventional study (NCT00536302) had been sponsored by the company Gelita and the company-specific brand of CH had been used. The authors also wish to thank Inge Berg-Scholl and Rolf Keiffer at Sanofi-Aventis Deutschland GmbH for performing the biomarker measurements.

RIGHTS & PERMISSIONS

2017 2017 by the Journal of Biomedical Research. All rights reserved