Literature DB >> 23162103

Therapy of hypoparathyroidism with PTH(1-84): a prospective four-year investigation of efficacy and safety.

Natalie E Cusano1, Mishaela R Rubin, Donald J McMahon, Chiyuan Zhang, Rebecca Ives, Amanda Tulley, James Sliney, Serge C Cremers, John P Bilezikian.   

Abstract

CONTEXT: 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.
DESIGN: 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.

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Year:  2012        PMID: 23162103      PMCID: PMC3537109          DOI: 10.1210/jc.2012-2984

Source DB:  PubMed          Journal:  J Clin Endocrinol Metab        ISSN: 0021-972X            Impact factor:   5.958


  16 in total

Review 1.  Mini-review: new therapeutic options in hypoparathyroidism.

Authors:  Natalie E Cusano; Mishaela R Rubin; James Sliney; John P Bilezikian
Journal:  Endocrine       Date:  2012-02-07       Impact factor: 3.633

Review 2.  Clinical practice. Hypoparathyroidism.

Authors:  Dolores Shoback
Journal:  N Engl J Med       Date:  2008-07-24       Impact factor: 91.245

Review 3.  Primary hyperparathyroidism: new concepts in clinical, densitometric and biochemical features.

Authors:  J P Bilezikian; M L Brandi; M Rubin; S J Silverberg
Journal:  J Intern Med       Date:  2005-01       Impact factor: 8.989

4.  Single-dose subcutaneous administration of recombinant human parathyroid hormone [rhPTH(1-84)] in healthy postmenopausal volunteers.

Authors:  H R Schwietert; E W Groen; F A Sollie; J H Jonkman
Journal:  Clin Pharmacol Ther       Date:  1997-03       Impact factor: 6.875

5.  Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis.

Authors:  R M Neer; C D Arnaud; J R Zanchetta; R Prince; G A Gaich; J Y Reginster; A B Hodsman; E F Eriksen; S Ish-Shalom; H K Genant; O Wang; B H Mitlak
Journal:  N Engl J Med       Date:  2001-05-10       Impact factor: 91.245

6.  Long-term treatment of hypoparathyroidism: a randomized controlled study comparing parathyroid hormone-(1-34) versus calcitriol and calcium.

Authors:  Karen K Winer; Chia Wen Ko; James C Reynolds; Karen Dowdy; Meg Keil; Donna Peterson; Lynn H Gerber; Charles McGarvey; Gordon B Cutler
Journal:  J Clin Endocrinol Metab       Date:  2003-09       Impact factor: 5.958

7.  Preserved three-dimensional cancellous bone structure in mild primary hyperparathyroidism.

Authors:  D W Dempster; R Müller; H Zhou; T Kohler; E Shane; M Parisien; S J Silverberg; J P Bilezikian
Journal:  Bone       Date:  2007-04-11       Impact factor: 4.398

8.  Comment on Kanis et al.: "European guidance for the diagnosis and management of osteoporosis in postmenopausal women".

Authors:  J O Clausen
Journal:  Osteoporos Int       Date:  2008-12-16       Impact factor: 4.507

9.  Skeletal disease in primary hyperparathyroidism.

Authors:  S J Silverberg; E Shane; L de la Cruz; D W Dempster; F Feldman; D Seldin; T P Jacobs; E S Siris; M Cafferty; M V Parisien
Journal:  J Bone Miner Res       Date:  1989-06       Impact factor: 6.741

10.  Subcutaneous administration of the amino-terminal fragment of human parathyroid hormone-(1-34): kinetics and biochemical response in estrogenized osteoporotic patients.

Authors:  R Lindsay; J Nieves; E Henneman; V Shen; F Cosman
Journal:  J Clin Endocrinol Metab       Date:  1993-12       Impact factor: 5.958

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  41 in total

Review 1.  Hypoparathyroidism.

Authors:  John P Bilezikian
Journal:  J Clin Endocrinol Metab       Date:  2020-06-01       Impact factor: 5.958

Review 2.  Recombinant Human Parathyroid Hormone (1-84): A Review in Hypoparathyroidism.

Authors:  Esther S Kim; Gillian M Keating
Journal:  Drugs       Date:  2015-07       Impact factor: 9.546

3.  Replantation with cryopreserved parathyroid for permanent hypoparathyroidism: a case report and review of literatures.

Authors:  Hai-Guang Liu; Zai-Chong Chen; Xiao-Hua Zhang; Kai Yang
Journal:  Int J Clin Exp Med       Date:  2015-03-15

4.  Parathyroid hormone therapy for hypoparathyroidism.

Authors:  Natalie E Cusano; Mishaela R Rubin; John P Bilezikian
Journal:  Best Pract Res Clin Endocrinol Metab       Date:  2014-09-10       Impact factor: 4.690

Review 5.  Impact of recombinant PTH on management of hypoparathyroidism: a systematic review.

Authors:  Y Ramakrishnan; H C Cocks
Journal:  Eur Arch Otorhinolaryngol       Date:  2015-01-08       Impact factor: 2.503

Review 6.  Use of parathyroid hormone in hypoparathyroidism.

Authors:  N E Cusano; M R Rubin; D Irani; J Sliney; J P Bilezikian
Journal:  J Endocrinol Invest       Date:  2013-12       Impact factor: 4.256

7.  Skeletal changes after restoration of the euparathyroid state in patients with hypoparathyroidism and primary hyperparathyroidism.

Authors:  Cristiana Cipriani; Alice Abraham; Barbara C Silva; Natalie E Cusano; Mishaela R Rubin; Donald J McMahon; Chengchen Zhang; Didier Hans; Shonni J Silverberg; John P Bilezikian
Journal:  Endocrine       Date:  2016-10-18       Impact factor: 3.633

Review 8.  Bone imaging in hypoparathyroidism.

Authors:  B C Silva; M R Rubin; N E Cusano; J P Bilezikian
Journal:  Osteoporos Int       Date:  2016-08-30       Impact factor: 4.507

9.  PTH1-34 alleviates radiotherapy-induced local bone loss by improving osteoblast and osteocyte survival.

Authors:  Abhishek Chandra; Tiao Lin; Mary Beth Tribble; Ji Zhu; Allison R Altman; Wei-Ju Tseng; Yejia Zhang; Sunday O Akintoye; Keith Cengel; X Sherry Liu; Ling Qin
Journal:  Bone       Date:  2014-07-01       Impact factor: 4.398

10.  The effect of PTH(1-84) on quality of life in hypoparathyroidism.

Authors:  Natalie E Cusano; Mishaela R Rubin; Donald J McMahon; Dinaz Irani; Amanda Tulley; James Sliney; John P Bilezikian
Journal:  J Clin Endocrinol Metab       Date:  2013-04-17       Impact factor: 5.958

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