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Randomized Controlled Trial
. 2009 Jul;24(7):1355-61.
doi: 10.1007/s00467-009-1143-8. Epub 2009 Mar 20.

Response of different PTH assays to therapy with sevelamer or CaCO3 and active vitamin D sterols

Affiliations
Randomized Controlled Trial

Response of different PTH assays to therapy with sevelamer or CaCO3 and active vitamin D sterols

Katherine Wesseling-Perry et al. Pediatr Nephrol. 2009 Jul.

Abstract

Amino-terminally truncated parathyroid hormone (PTH) fragments are detected to differing degrees by first- and second-generation immunometric PTH assays (PTH-IMAs), and acute changes in serum calcium affect the proportion of these fragments in circulation. However, the effect of chronic calcium changes and different vitamin D doses on these PTH measurements remains to be defined. In this study, 60 pediatric dialysis patients, aged 13.9 +/- 0.7 years, with secondary hyperparathyroidism were randomized to 8 months of therapy with oral vitamin D combined with either calcium carbonate (CaCO(3)) or sevelamer. Serum phosphorus levels did not differ between groups. Serum calcium levels rose from 9.3 +/- 0.1 to 9.7 +/- 0.1 mg/dl during CaCO(3) therapy (p < 0.01 from baseline) but remained unchanged during sevelamer therapy. In the CaCO(3) and sevelamer groups, baseline serum PTH levels (1st PTH-IMA; Nichols Institute Diagnostics, San Clemente, CA) were 964 +/- 75 and 932 +/- 89 pg/ml, and levels declined to 491 +/- 55 and 543 +/- 59 pg/ml, respectively (nonsignificant between groups). Patients treated with sevelamer received higher doses of vitamin D than those treated with CaCO(3). The PTH values obtained by first- and second-generation PTH-IMAs correlated closely throughout therapy and the response of PTH was similar to both PTH-IMAs, despite differences in serum calcium levels.

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Figures

Fig. 1
Fig. 1
Serum phosphorus (squares) and calcium (circles) levels throughout the study in patients treated with CaCO3 (closed symbols) versus sevelamer (open symbols). The asterisk indicates a significant change from baseline (p < 0.01), while the double dagger indicates a difference between the sevelamer and CaCO3 treatment groups (p < 0.01)
Fig. 2
Fig. 2
Serum parathyroid hormone (PTH) values throughout the course of the study in patients treated with CaCO3 (a) and those treated with sevelamer (b). PTH levels were determined by the first-generation immunometric assay by Nichols (1st PTH-IMA; closed diamonds) and by the 1st PTH-IMA (open diamonds) and second-generation (2nd) PTH-IMA (closed triangles) by Immutopics. The asterisk indicates a significant (p < 0.01) decrease from baseline

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