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Intravenous calcitriol for treatment of hyperparathyroidism in children on hemodialysis.
Pediatr Nephrol. 2005 May; 20(5):622-30.PN

Abstract

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.

Authors+Show Affiliations

Department of Pediatrics, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI 53226, USA. lgreen@mcw.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15785941

Citation

Greenbaum, Larry A., et al. "Intravenous Calcitriol for Treatment of Hyperparathyroidism in Children On Hemodialysis." Pediatric Nephrology (Berlin, Germany), vol. 20, no. 5, 2005, pp. 622-30.
Greenbaum LA, Grenda R, Qiu P, et al. Intravenous calcitriol for treatment of hyperparathyroidism in children on hemodialysis. Pediatr Nephrol. 2005;20(5):622-30.
Greenbaum, L. A., Grenda, R., Qiu, P., Restaino, I., Wojtak, A., Paredes, A., Benador, N., Melnick, J. Z., Williams, L. A., & Salusky, I. B. (2005). Intravenous calcitriol for treatment of hyperparathyroidism in children on hemodialysis. Pediatric Nephrology (Berlin, Germany), 20(5), 622-30.
Greenbaum LA, et al. Intravenous Calcitriol for Treatment of Hyperparathyroidism in Children On Hemodialysis. Pediatr Nephrol. 2005;20(5):622-30. PubMed PMID: 15785941.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intravenous calcitriol for treatment of hyperparathyroidism in children on hemodialysis. AU - Greenbaum,Larry A, AU - Grenda,Ryszard, AU - Qiu,Ping, AU - Restaino,Irene, AU - Wojtak,Amy, AU - Paredes,Ana, AU - Benador,Nadine, AU - Melnick,Joel Z, AU - Williams,Laura A, AU - Salusky,Isidro B, Y1 - 2005/03/23/ PY - 2003/09/24/received PY - 2004/10/28/accepted PY - 2004/10/27/revised PY - 2005/3/24/pubmed PY - 2005/7/7/medline PY - 2005/3/24/entrez SP - 622 EP - 30 JF - Pediatric nephrology (Berlin, Germany) JO - Pediatr Nephrol VL - 20 IS - 5 N2 - 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. SN - 0931-041X UR - https://www.unboundmedicine.com/medline/citation/15785941/Intravenous_calcitriol_for_treatment_of_hyperparathyroidism_in_children_on_hemodialysis_ L2 - https://dx.doi.org/10.1007/s00467-004-1792-6 DB - PRIME DP - Unbound Medicine ER -