title: Long-term treatment of hypoparathyroidism: a randomized controlled study comparing parathyroid hormone-(1-34) versus calcitriol and calcium.
abstract: Hypoparathyroidism is one of the few remaining hormonal insufficiency states for which replacement therapy is unavailable. Previous short-term controlled trials have shown PTH to be a safe and effective treatment of hypoparathyroidism. In this randomized, parallel group, open-label trial, we compared synthetic human PTH-(1-34) (PTH) with conventional therapy, calcitriol and calcium, over a 3-yr period. Twenty-seven patients with confirmed hypoparathyroidism, aged 18-70 yr, were randomized to either twice daily sc PTH or oral calcitriol and calcium. The primary end points were calcium levels in serum and urine. Secondary end points were creatinine clearance, markers of bone turnover, and bone mineral density. Throughout the 3-yr study period, serum calcium levels were similar in both treatment groups within or just below the normal range. Mean urinary calcium excretion was within the normal range from 1-3 yr in PTH-treated patients, but remained above normal in the calcitriol group. Bone mineral content and bone mineral density showed no significant between-group differences over the 3-yr study period. We conclude that treatment with twice daily sc PTH provides a safe and effective alternative to calcitriol therapy and is able to maintain normal serum calcium levels without hypercalciuria for at least 3 yr in patients with hypoparathyroidism.
authors.affiliation: Pediatric and Reproductive Endocrinology Branch, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland 20892, USA. winerk@mail.nih.gov
authors.forename: Karen K
authors.initials: KK
authors.lastname: Winer
authors.forename: Chia Wen
authors.initials: CW
authors.lastname: Ko
authors.forename: James C
authors.initials: JC
authors.lastname: Reynolds
authors.forename: Karen
authors.initials: K
authors.lastname: Dowdy
authors.forename: Meg
authors.initials: M
authors.lastname: Keil
authors.forename: Donna
authors.initials: D
authors.lastname: Peterson
authors.forename: Lynn H
authors.initials: LH
authors.lastname: Gerber
authors.forename: Charles
authors.initials: C
authors.lastname: McGarvey
authors.forename: Gordon B
authors.initials: GB
authors.lastname: Cutler
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000469:Alkaline Phosphatase / Q000378:metabolism; D000596:Amino Acids / Q000652:urine; D015519:Bone Density / Q000187:drug effects; D001842:Bone and Bones / Q000187:drug effects / Q000378:metabolism; D002117:Calcitriol / Q000627:therapeutic use*; D002118:Calcium / Q000097:blood / Q000627:therapeutic use* / Q000652:urine; D002120:Calcium Channel Agonists / Q000627:therapeutic use*; D003404:Creatinine / Q000378:metabolism; D005260:Female; D006801:Humans; D007011:Hypoparathyroidism / Q000150:complications / Q000188:drug therapy*; D008274:Magnesium / Q000097:blood / Q000652:urine; D008297:Male; D008875:Middle Aged; D009397:Nephrocalcinosis / Q000000981:diagnostic imaging / Q000209:etiology; D010758:Phosphorus / Q000652:urine; D011859:Radiography; D019379:Teriparatide / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000596:Amino Acids; D002120:Calcium Channel Agonists; D019379:Teriparatide; D010758:Phosphorus; C015484:pyridinoline; D003404:Creatinine; D000469:Alkaline Phosphatase; D002117:Calcitriol; D008274:Magnesium; D002118:Calcium