title: Sevelamer controls parathyroid hormone-induced bone disease as efficiently as calcium carbonate without increasing serum calcium levels during therapy with active vitamin D sterols.
abstract: Little is known about the impact of various phosphate binders on the skeletal lesions of secondary hyperparathyroidism (2 degrees HPT). The effects of calcium carbonate (CaCO3) and sevelamer were compared in pediatric peritoneal dialysis patients with bone biopsy-proven 2 degrees HPT. Twenty-nine patients were randomly assigned to CaCO3 (n = 14) or sevelamer (n = 15), concomitant with either intermittent doses of oral calcitriol or doxercalciferol for 8 mo, when bone biopsies were repeated. Serum phosphorus, calcium, parathyroid hormone (PTH), and alkaline phosphatase were measured monthly. The skeletal lesions of 2 degrees HPT improved with both binders, and bone formation rates reached the normal range in approximately 75% of the patients. Overall, serum phosphorus levels were 5.5 +/- 0.1 and 5.6 +/- 0.3 mg/dl (NS) with CaCO3 and sevelamer, respectively. Serum calcium levels and the Ca x P ion product increased with CaCO3; in contrast, values remained unchanged with sevelamer (9.6 +/- 01 versus 8.9 +/- 0.2 mg/dl; P < 0.001, respectively). Hypercalcemic episodes (>10.2 mg/dl) occurred more frequently with CaCO3 (P < 0.01). Baseline PTH levels were 980 +/- 112 and 975 +/- 174 pg/ml (NS); these values decreased to 369 +/- 92 (P < 0.01) and 562 +/- 164 pg/ml (P < 0.01) in the CaCO3 and the sevelamer groups, respectively (NS between groups). Serum alkaline phosphatase levels also diminished in both groups (P < 0.01). Thus, treatment with either CaCO3 or sevelamer resulted in equivalent control of the biochemical and skeletal lesions of 2 degrees HPT. Sevelamer, however, maintained serum calcium concentrations closer to the lower end of the normal physiologic range, thereby increasing the safety of treatment with active vitamin D sterols.
authors.affiliation: David Geffen School of Medicine at UCLA, Division of Nephrology, 10833 Le Conte Boulevard, Box 951752, Los Angeles, CA 90095-1752, USA. isalusky@mednet.ucla.edu
authors.forename: Isidro B
authors.initials: IB
authors.lastname: Salusky
authors.forename: William G
authors.initials: WG
authors.lastname: Goodman
authors.forename: Shobha
authors.initials: S
authors.lastname: Sahney
authors.forename: Barbara
authors.initials: B
authors.lastname: Gales
authors.forename: Ashley
authors.initials: A
authors.lastname: Perilloux
authors.forename: He-Jing
authors.initials: HJ
authors.lastname: Wang
authors.forename: Robert M
authors.initials: RM
authors.lastname: Elashoff
authors.forename: Harald
authors.initials: H
authors.lastname: Jüppner
mesh_terms: D000293:Adolescent; D000328:Adult; D000469:Alkaline Phosphatase / Q000097:blood; D000704:Analysis of Variance; D001706:Biopsy; D001774:Blood Chemical Analysis; D001847:Bone Diseases / Q000139:chemically induced* / Q000188:drug therapy*; D001842:Bone and Bones / Q000187:drug effects* / Q000378:metabolism; D002117:Calcitriol / Q000008:administration & dosage; D002118:Calcium / Q000097:blood / Q000378:metabolism; D002119:Calcium Carbonate / Q000378:metabolism / Q000494:pharmacology*; D002648:Child; D002675:Child, Preschool; D004872:Ergocalciferols / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007223:Infant; D008137:Longitudinal Studies; D008297:Male; D010281:Parathyroid Hormone / Q000009:adverse effects* / Q000031:analogs & derivatives / Q000378:metabolism; D011073:Polyamines / Q000494:pharmacology*; D011446:Prospective Studies; D011485:Protein Binding; D000069603:Sevelamer; D013261:Sterols / Q000378:metabolism / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000378:metabolism / Q000627:therapeutic use*
chemical_list: D004872:Ergocalciferols; C470125:PTH protein, human; D010281:Parathyroid Hormone; D011073:Polyamines; D013261:Sterols; D014807:Vitamin D; C042533:1 alpha-hydroxyergocalciferol; D000069603:Sevelamer; D000469:Alkaline Phosphatase; D002117:Calcitriol; D002119:Calcium Carbonate; D002118:Calcium