Calcitriol pulse therapy is not more effective than daily calcitriol therapy in controlling secondary hyperparathyroidism in children with chronic renal failure

Calcitriol oral pulse therapy has been suggested as the treatment of choice for secondary hyperparathyroidism, but its efficacy and safety are still u nder discussion. The present randomized multicenter study compares the effe ct of an 8-week course of daily versus intermittent (twice weekly) calcitri ol therapy on parathyroid hormone (PTH) suppression in 59 children (mean ag e 8.4+/-4.7 years) with chronic renal insufficiency (mean C-cr 22.4+/-11.6 ml/min per 1.73 m(2)) and secondary hyperparathyroidism. After a 3-week was hout period, the patients were randomly assigned to treatment with daily or al calcitriol (10 ng/kg per day) or intermittent oral calcitriol (35 ng/kg given twice a week). The calcitriol dose was not changed throughout the stu dy period of 8 weeks. At start of the study, the median intact PTH (iPTH) l evel was 485 pg/ml (range 83-2032) in the daily group (n=29) and 315 pg/ml (range 93-1638) in the intermittent group (n=30), After 8 weeks, the respec tive median iPTH concentrations were 232 pg/ml (range 63-1614) and 218 pg/m l (range 2-1785) (ns). The mean iPTH decrease from baseline was 19.2+/-57.8 % and 13.7+/-46.7% respectively (not significant). Calcitriol reduced the i PTH concentration in 23/29 patients in the daily group and in 21/30 in the intermittent group. One episode of hypercalcemia (>11.5 mg/dl) was observed in both groups and a single episode of hyperphosphatemia (>7.5 mg/dl) was observed in the daily group. It is concluded that oral calcitriol pulse the rapy does not control secondary hyperparathyroidism more effectively than t he daily administration of calcitriol in children with chronic renal failur e prior to dialysis.