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Randomized Controlled Trial
. 2013 Sep;28(9):2383-92.
doi: 10.1093/ndt/gft203. Epub 2013 Jun 19.

A comparison of calcium acetate/magnesium carbonate and sevelamer-hydrochloride effects on fibroblast growth factor-23 and bone markers: post hoc evaluation from a controlled, randomized study

Affiliations
Randomized Controlled Trial

A comparison of calcium acetate/magnesium carbonate and sevelamer-hydrochloride effects on fibroblast growth factor-23 and bone markers: post hoc evaluation from a controlled, randomized study

Adrian Covic et al. Nephrol Dial Transplant. 2013 Sep.

Abstract

Background: Different phosphate binders exert differing effects on bone mineral metabolism and levels of regulating hormones. The objective of this post hoc evaluation of the CALcium acetate MAGnesium carbonate (CALMAG) study was to compare the effects of calcium acetate/magnesium carbonate (CaMg) and a calcium-free phosphate binder, sevelamer-hydrochloride (HCl), on serum levels of fibroblast growth factor-23 (FGF-23) and markers of bone turnover.

Methods: This secondary analysis of the controlled, randomized CALMAG study, comparing the effect of CaMg and sevelamer-HCl on serum phosphorus (P), aimed to investigate the parameters described above. The analysis included 204 patients who completed the initial study per protocol (CaMg, n = 105; sevelamer-HCl, n = 99).

Results: The study showed that serum levels of FGF-23 were significantly reduced with CaMg and sevelamer-HCl, with no difference between groups at Week 25 [analysis of covariance (ANCOVA); log-intact FGF-23 (iFGF-23), P = 0.1573]. FGF-23 levels strongly correlated with serum P levels at all time points in both groups. The bone turnover parameters alkaline phosphatase (AP), bone AP (BAP), procollagen type 1 amino-terminal propeptide 1 (P1NP), osteoprotegerin (OPG), beta-crosslaps (β-CTX) and tartrate-resistant acid phosphatase 5b (TRAP 5b) increased significantly in the sevelamer-HCl group; they remained almost unchanged in the CaMg group, after the initial phase of P lowering (ANCOVA, P < 0.0001 for all except OPG, P = 0.1718).

Conclusions: CaMg and sevelamer-HCl comparably lower serum levels of iFGF-23. Changes in bone parameters were dependent on characteristics of the phosphate binder; in contrast with sevelamer-HCl, CaMg had no influence on bone turnover markers.

Keywords: bone markers; calcium acetate; fibroblast growth factor-23; haemodialysis; magnesium carbonate; phosphate binder.

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Figures

FIGURE 1:
FIGURE 1:
View of selected parameters from Tables 2 and 3 to illustrate the impact of phosphate binders on serum levels of (a) phosphorus, (b) log-intact FGF-23, (c) bone AP and (d) beta-crosslaps. Time course of values at Weeks 9 and 25 of the calcium acetate/magnesium carbonate group (n = 105) and of the sevelamer-HCl group (n = 99) (PPS) is displayed in white and grey, respectively. Probability values are the result of the Wilcoxon test for within-group significance (Week 9 versus Week 1 and Week 25 versus Week 9, respectively) and repeated measures ANCOVA for between-group evaluation (indicated by asterisks). The plotted values indicate medians and interquartile range, with 10th and 90th percentiles as the error bars.

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