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Sevelamer Controls Parathyroid Hormone–Induced Bone Disease as Efficiently as Calcium Carbonate without Increasing Serum Calcium Levels during Therapy with Active Vitamin D Sterols

Isidro B. Salusky^*, William G. Goodman, Shobha Sahney^||, Barbara Gales^*, Ashley Perilloux, He-Jing Wang, Robert M. Elashoff and Harald Jüppner^¶

Departments of ^* Pediatrics, Medicine, and Biomathematics, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California; Davita/UCLA Pediatrics Dialysis, ^|| Department of Pediatrics, Loma Linda Medical Center, Loma Linda, California; and the ^¶ Endocrine Unit and Pediatric Nephrology Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts

Address correspondence to: Dr. Isidro B. Salusky, David Geffen School of Medicine at UCLA, Division of Nephrology, 10833 Le Conte Boulevard, Box 951752, Los Angeles, CA 90095-1752. Phone: 310-206-9295; Fax: 310-824-9224; isalusky{at}mednet.ucla.edu

Received for publication October 25, 2004. Accepted for publication May 6, 2005.

Little is known about the impact of various phosphate binders on the skeletal lesions of secondary hyperparathyroidism (2°HPT). The effects of calcium carbonate (CaCO₃) and sevelamer were compared in pediatric peritoneal dialysis patients with bone biopsy-proven 2°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°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°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.

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