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Effects of Once Versus Twice-Daily Parathyroid Hormone 1–34 Therapy in Children with Hypoparathyroidism

National Institute of Child Health and Human Development (K.K.W., D.P., B.S., G.B.C.), National Institutes of Health, Bethesda, Maryland 20892-7510; and Biostatistics and Clinical Epidemiology Service (N.S.), National Institutes of Health Clinical Center, Bethesda, Maryland 20892

Address all correspondence and requests for reprints to: Karen K. Winer, M.D., National Institutes of Health, National Institute of Child Health and Human Development/Center for Research for Mothers & Children/Endocrinology, Nutrition,and Growth Branch, Building 6100, Room 4B11, Bethesda, Maryland 20892-7510. E-mail: winerk{at}mail.nih.gov.

Context: Hypoparathyroidism is among the few hormonal insufficiency states not treated with replacement of the missing hormone. Long-term conventional therapy with vitamin D and analogs may lead to nephrocalcinosis and renal insufficiency.

Objective: Our objective was to compare the response of once-daily vs. twice-daily PTH 1–34 treatment in children with hypoparathyroidism.

Setting: The study was conducted at a clinical research center.

Subjects: Fourteen children ages 4–17 yr with chronic hypoparathyroidism were studied.

Study Design: This was a randomized cross-over trial, lasting 28 wk, which compared two dose regimens, once-daily vs. twice-daily PTH1–34. Each 14-wk study arm was divided into a 2-wk inpatient dose-adjustment phase and a 12-wk outpatient phase.

Results: Mean predose serum calcium was maintained at levels just below the normal range. Repeated serum measures over a 24-h period showed that twice-daily PTH 1–34 increased serum calcium and magnesium levels more effectively than a once-daily dose. This was especially evident during the second half of the day (12–24 h). PTH 1–34 normalized mean 24-h urine calcium excretion on both treatment schedules. This was achieved with half the PTH 1–34 dose during the twice-daily regimen compared with the once-daily regimen (twice-daily, 25 ±15 µg/d vs. once-daily, 58 ± 28 µg/d; P < 0.001).

Conclusions: We conclude that a twice-daily PTH 1–34 regimen provides a more effective treatment of hypoparathyroidism compared with once-daily treatment because it reduces the variation in serum calcium levels and accomplishes this at a lower total daily PTH 1–34 dose. The results showed, as in the previous study of adult patients with hypoparathyroidism, that a twice-daily regimen produced significantly improved metabolic control compared with once-daily PTH 1–34.

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