Can we compare serum sclerostin results obtained with different assays in hemodialysis patients?

Sclerostin, secreted by osteocytes, plays a key role in antagonizing bone formation. Recent studies, which seldom include chronic kidney disease (CKD) patients, have reported on the association of sclerostin and mortality, with contradictory results. The assay-linked variability may contribute to these discrepant results. We have compared sclerostin results obtained with two assays (TECO and Biomedica) in a cohort of 91 CKD patients undergoing hemodialysis. We found a strong correlation (r = 0.870, p < 0.0001) between the serum sclerostin concentrations measured by the two assays. Bland-Altman plot shows that, although there was a partial agreement between the assays, differences found for individual values (-0.27 +/- A 0.54; ranging from -1.3 to 0.8 ng/ml) were quite unpredictable. By using TECO, there was a significant relationship between serum sclerostin, and calcitonin (r = 0.224), IL-6 (r = 0.251) and FGF23 (r = 0.331) levels while no correlation was found with PTH or total alkaline phosphatase. Regarding Biomedica, there was a significant correlation with calcitonin (r = 0.260), and beta(2) microglobulin (r = 0.210), but no correlation with PTH or total alkaline phosphatase. Overall, 25.3 % among the patients had different classifications as to normal or high values, according to the manufacturer. Sclerostin levels should be interpreted with caution, as they can vary widely according to the assay used. Further studies are clearly needed before considering sclerostin as a true marker of mortality. Moreover, we do not know at present which serum sclerostin levels should be regarded as either normal or potentially dangerous in patients with CKD.