title: Therapy of hypoparathyroidism with PTH(1-84): a prospective four-year investigation of efficacy and safety.
abstract: BACKGROUND
  PTH may be an effective treatment option for hypoparathyroidism, but long-term data are not available.
  
  
  OBJECTIVE
  We studied the effect of 4 yr of PTH(1-84) treatment in hypoparathyroidism.
  
  
  METHODS
  Twenty-seven subjects were treated with PTH(1-84) for 4 yr, with prospective monitoring of calcium and vitamin D requirements, serum and urinary calcium, serum phosphorus, bone turnover markers, and bone mineral density (BMD).
  
  
  RESULTS
  Treatment with PTH(1-84) reduced supplemental calcium requirements by 37% (P = 0.006) and 1,25-dihydroxyvitamin D requirements by 45% (P = 0.008). Seven subjects (26%) were able to stop 1,25-dihydroxyvitamin D completely. Serum calcium concentration remained stable, and urinary calcium and phosphorus excretion fell. Lumbar spine BMD increased by 5.5 ± 9% at 4 yr (P < 0.0001). Femoral neck and total hip BMD remained stable. At 4 yr, distal radius BMD was not different from baseline. Bone turnover markers increased significantly, reaching a 3-fold peak from baseline values at 6-12 months (P < 0.05 for all), subsequently declining to steady-state levels at 30 months. Hypercalcemia was uncommon (11 episodes in eight subjects over 4 yr; 1.9% of all values), with most episodes occurring within the first 6 months and resolving with adjustment of supplemental calcium and vitamin D.
  
  
  CONCLUSIONS
  PTH(1-84) treatment of hypoparathyroidism for up to 4 yr maintains the serum calcium concentration, while significantly reducing supplemental calcium and 1,25-dihydroxyvitamin D requirements. Lumbar spine BMD increases without significant changes at other sites. These data provide support for the safety and efficacy of PTH(1-84) therapy in hypoparathyroidism for up to 4 yr.
authors.affiliation: Department of Medicine, Division of Endocrinology, College of Physicians and Surgeons, Columbia University, New York, New York 10032, USA.
authors.forename: Natalie E
authors.initials: NE
authors.lastname: Cusano
authors.forename: Mishaela R
authors.initials: MR
authors.lastname: Rubin
authors.forename: Donald J
authors.initials: DJ
authors.lastname: McMahon
authors.forename: Chiyuan
authors.initials: C
authors.lastname: Zhang
authors.forename: Rebecca
authors.initials: R
authors.lastname: Ives
authors.forename: Amanda
authors.initials: A
authors.lastname: Tulley
authors.forename: James
authors.initials: J
authors.lastname: Sliney
authors.forename: Serge C
authors.initials: SC
authors.lastname: Cremers
authors.forename: John P
authors.initials: JP
authors.lastname: Bilezikian
mesh_terms: D000328:Adult; D000368:Aged; D002118:Calcium / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D020249:Hormone Replacement Therapy / Q000009:adverse effects; D006801:Humans; D007011:Hypoparathyroidism / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D014807:Vitamin D / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D010281:Parathyroid Hormone; D014807:Vitamin D; C097949:1,25-dihydroxyvitamin D; D002118:Calcium