title: Effects of once versus twice-daily parathyroid hormone 1-34 therapy in children with hypoparathyroidism.
abstract: BACKGROUND
  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.
  
  
  METHODS
  The study was conducted at a clinical research center.
  
  
  METHODS
  Fourteen children ages 4-17 yr with chronic hypoparathyroidism were studied.
  
  
  METHODS
  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.
authors.affiliation: National Institute of Child Health and Human Development, National Institutes of Health, Building 6100, Room 4B11, Bethesda, Maryland 20892-7510, USA. winerk@mail.nih.gov
authors.forename: Karen K
authors.initials: KK
authors.lastname: Winer
authors.forename: Ninet
authors.initials: N
authors.lastname: Sinaii
authors.forename: Donna
authors.initials: D
authors.lastname: Peterson
authors.forename: Bruno
authors.initials: B
authors.lastname: Sainz
authors.forename: Gordon B
authors.initials: GB
authors.lastname: Cutler
mesh_terms: D000293:Adolescent; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects; D002118:Calcium / Q000097:blood / Q000652:urine; D002648:Child; D002675:Child, Preschool; D003404:Creatinine / Q000652:urine; D018592:Cross-Over Studies; D000242:Cyclic AMP / Q000652:urine; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007011:Hypoparathyroidism / Q000097:blood / Q000188:drug therapy* / Q000652:urine; D008274:Magnesium / Q000097:blood / Q000652:urine; D008297:Male; D010758:Phosphorus / Q000097:blood / Q000652:urine; D019379:Teriparatide / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide; D010758:Phosphorus; D003404:Creatinine; D000242:Cyclic AMP; D008274:Magnesium; D002118:Calcium