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

J Clin Endocrinol Metab. 2008 Sep;93(9):3389-95. doi: 10.1210/jc.2007-2552. Epub 2008 May 20.

Abstract

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 microg/d vs. once-daily, 58 +/- 28 microg/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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Bone Density Conservation Agents / administration & dosage
  • Bone Density Conservation Agents / adverse effects
  • Calcium / blood
  • Calcium / urine
  • Child
  • Child, Preschool
  • Creatinine / urine
  • Cross-Over Studies
  • Cyclic AMP / urine
  • Drug Administration Schedule
  • Female
  • Humans
  • Hypoparathyroidism / blood
  • Hypoparathyroidism / drug therapy*
  • Hypoparathyroidism / urine
  • Magnesium / blood
  • Magnesium / urine
  • Male
  • Phosphorus / blood
  • Phosphorus / urine
  • Teriparatide / administration & dosage*
  • Teriparatide / adverse effects
  • Time Factors

Substances

  • Bone Density Conservation Agents
  • Teriparatide
  • Phosphorus
  • Creatinine
  • Cyclic AMP
  • Magnesium
  • Calcium