Intravenous calcitriol for treatment of hyperparathyroidism in children on hemodialysis

This double-blind, placebo-controlled study evaluated the safety and efficacy of intravenous (i.v.) calcitriol (Calcijex) for treatment of secondary hyperparathyroidism (secondary HPT) in pediatric end-stage renal disease (ESRD) patients on hemodialysis (HD). After a 2 to 6-week washout period of al...

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Bibliographic Details
Published in:	Pediatric nephrology (Berlin, West) Vol. 20; no. 5; pp. 622 - 630
Main Authors:	Greenbaum, Larry A, Grenda, Ryszard, Qiu, Ping, Restaino, Irene, Wojtak, Amy, Paredes, Ana, Benador, Nadine, Melnick, Joel Z, Williams, Laura A, Salusky, Isidro B
Format:	Journal Article
Language:	English
Published:	Germany Springer 01-05-2005 Springer Nature B.V
Subjects:	Acetates - administration & dosage Adolescent Calcitriol Calcitriol - administration & dosage Calcitriol - adverse effects Calcium - blood Calcium Carbonate - administration & dosage Calcium Channel Agonists - administration & dosage Calcium Channel Agonists - adverse effects Calcium Compounds Child Child, Preschool Chronic Kidney Disease-Mineral and Bone Disorder - drug therapy Chronic Kidney Disease-Mineral and Bone Disorder - etiology Diseases Dosage and administration Drug therapy Female Hemodialysis patients Humans Hyperparathyroidism Hyperparathyroidism, Secondary - drug therapy Hyperparathyroidism, Secondary - etiology Injections, Intravenous Kidney Failure, Chronic - complications Kidney Failure, Chronic - therapy Male Parathyroid Hormone - blood Phosphates - blood Renal Dialysis United States
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Summary:	This double-blind, placebo-controlled study evaluated the safety and efficacy of intravenous (i.v.) calcitriol (Calcijex) for treatment of secondary hyperparathyroidism (secondary HPT) in pediatric end-stage renal disease (ESRD) patients on hemodialysis (HD). After a 2 to 6-week washout period of all vitamin D compounds, patients with two consecutive PTH values > 400 pg mL(-1), calcium levels < or = 10.5 mg dL(-1) and calcium x phosphorus product values < or = 70 mg2 dL(-2) were eligible for the treatment phase. Patients received a bolus injection of calcitriol or placebo three times a week, immediately after dialysis for up to 12 weeks. Initial doses (0.5-1.5 microg) were based on the severity of secondary HPT. The dose was increased every two weeks by 0.25 microg until there was at least a 30% decrease in PTH from baseline, or Ca > 11.0 mg dL(-1), or Ca x P > 75 mg2 dL(-2). Overall, 11/21 (52%) patients in the calcitriol group had two consecutive > or = 30% decreases from baseline in serum PTH compared with 5/26 (19%) patients in the placebo group (P=0.03). The mean total alkaline phosphatase decreased from 274 to 232 IU L(-1) in the calcitriol group and increased from 547 to 669 IU L(-1) in the placebo group (P=0.002). The mean bone-specific alkaline phosphatase decreased from 72.5 to 68 microg L(-1) in the calcitriol group and increased from 105.3 to 148.5 microg L(-1) in the placebo group (P=0.03). The incidence of two consecutive occurrences of elevated calcium x phosphorus (Ca x P > 75 mg2 dL(-2)) product was higher in the calcitriol group than in the placebo group (P=0.01). Two consecutive occurrences of phosphorus > 6.5 mg dL(-1) occurred in 71% of the calcitriol group and 46% of the placebo group (P=0.14). Calcium levels > 10.5 mg dL(-1) were more common in the calcitriol group than in the placebo group (P=0.01). There was a direct relationship between serum phosphorus concentration and the percentage change in PTH from baseline in both the calcitriol group (r=0.46; P<0.0001) and the placebo group (r=0.21; P=0.0005). This study demonstrates that i.v. calcitriol, at initial doses of 0.5-1.5 microg, effectively reduces PTH levels in pediatric HD patients and that patients should be closely monitored for hyperphosphatemia and elevated Ca x P product.
ISSN:	0931-041X 1432-198X
DOI:	10.1007/s00467-004-1792-6