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RCT · 2016 · n=30

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

McAlindon T, Bartnik E, Ried JS, Teichert L, Herrmann M, Flechsenhar K · Journal of Biomedical Research

Preclinicalcounts toward this tier

Biomarkers moved in the expected direction — the type II procollagen synthesis marker PIIANP rose 29.9% versus 1.2% on placebo at 24 weeks, and the aggrecan epitope CS846 was lower on collagen. But the finding that matters is negative: 'Consistent correlations of changes in biomarkers PIIANP and CS846 with changes of the dGEMRIC score could not be observed.' The biochemical and imaging signals did not track each other.

Population
Serum biomarker re-analysis of the same 30 participants from the dGEMRIC trial (NCT00536302)
Intervention
Collagen hydrolysate
Comparator
Placebo
Limitations
Post-hoc re-analysis of a 30-person pilot, so it inherits every limitation of the parent trial. Five of the six authors are employees of Sanofi-Aventis Deutschland GmbH. The failure of the markers to correlate with the imaging undercuts a coherent mechanistic story rather than supporting one.

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