Synthetic human parathyroid hormone 1-34 replacement therapy: a randomized crossover trial comparing pump versus injections in the treatment of chronic hypoparathyroidism
- PMID: 22090268
- PMCID: PMC3275355
- DOI: 10.1210/jc.2011-1908
Synthetic human parathyroid hormone 1-34 replacement therapy: a randomized crossover trial comparing pump versus injections in the treatment of chronic hypoparathyroidism
Erratum in
- J Clin Endocrinol Metab. 2015 Jul;100(7):2800
Abstract
Context: Vitamin D therapy for hypoparathyroidism does not restore PTH-dependent renal calcium reabsorption, which can lead to renal damage. An alternative approach, PTH 1-34 administered twice daily, provides acceptable long-term treatment but is associated with nonphysiological serum calcium fluctuation.
Objective: Our objective was to compare continuous PTH 1-34 delivery, by insulin pump, with twice-daily delivery.
Research design and methods: In a 6-month, open-label, randomized, crossover trial, PTH 1-34 was delivered by pump or twice-daily sc injection. After each 3-month study period, serum and 24-h urine mineral levels and bone turnover markers were measured daily for 3 d, and 24-h biochemical profiles were determined for serum minerals and 1,25-dihydroxyvitamin D(3) and for urine minerals and cAMP. STUDY PARTICIPANTS AND SETTING: Eight patients with postsurgical hypoparathyroidism (mean ± sd age 46 ± 5.6 yr) participated at a tertiary care referral center.
Results: Pump vs. twice-daily delivery of PTH 1-34 produced less fluctuation in serum calcium, a more than 50% reduction in urine calcium (P = 0.002), and a 65% reduction in the PTH dose to maintain eucalcemia (P < 0.001). Pump delivery also produced higher serum magnesium level (P = 0.02), normal urine magnesium, and reduced need for magnesium supplements. Finally, pump delivery normalized bone turnover markers and significantly lowered urinary cross-linked N-telopeptide of type 1 collagen and pyridinium crosslinks compared with twice-daily injections (P < 0.05).
Conclusion: Pump delivery of PTH 1-34 provides the closest approach to date to physiological replacement therapy for hypoparathyroidism.
Figures
Similar articles
-
Effects of pump versus twice-daily injection delivery of synthetic parathyroid hormone 1-34 in children with severe congenital hypoparathyroidism.J Pediatr. 2014 Sep;165(3):556-63.e1. doi: 10.1016/j.jpeds.2014.04.060. Epub 2014 Jun 16. J Pediatr. 2014. PMID: 24948345 Free PMC article. Clinical Trial.
-
Pharmacokinetics and pharmacodynamics of subcutaneous recombinant parathyroid hormone (1-84) in patients with hypoparathyroidism: an open-label, single-dose, phase I study.Clin Ther. 2014 May;36(5):722-36. doi: 10.1016/j.clinthera.2014.04.001. Epub 2014 May 5. Clin Ther. 2014. PMID: 24802860 Clinical Trial.
-
Long-term treatment of 12 children with chronic hypoparathyroidism: a randomized trial comparing synthetic human parathyroid hormone 1-34 versus calcitriol and calcium.J Clin Endocrinol Metab. 2010 Jun;95(6):2680-8. doi: 10.1210/jc.2009-2464. Epub 2010 Apr 14. J Clin Endocrinol Metab. 2010. PMID: 20392870 Free PMC article. Clinical Trial.
-
Advances in the treatment of hypoparathyroidism with PTH 1-34.Bone. 2019 Mar;120:535-541. doi: 10.1016/j.bone.2018.09.018. Epub 2018 Sep 21. Bone. 2019. PMID: 30243992 Review.
-
PTH replacement therapy of hypoparathyroidism.Osteoporos Int. 2013 May;24(5):1529-36. doi: 10.1007/s00198-012-2230-4. Epub 2012 Nov 27. Osteoporos Int. 2013. PMID: 23184178 Review.
Cited by
-
Hypoparathyroidism: an update on new therapeutic approaches.Endocrine. 2024 Oct 13. doi: 10.1007/s12020-024-04057-y. Online ahead of print. Endocrine. 2024. PMID: 39397231 Review.
-
Preclinical development of EXT608, an investigational parathyroid hormone derivative with extended half-life for the treatment of hypoparathyroidism.JBMR Plus. 2024 Apr 18;8(6):ziae045. doi: 10.1093/jbmrpl/ziae045. eCollection 2024 Jun. JBMR Plus. 2024. PMID: 38721043 Free PMC article.
-
New insights into the vitamin D/PTH axis in endocrine-driven metabolic bone diseases.Endocrine. 2024 Sep;85(3):1007-1019. doi: 10.1007/s12020-024-03784-6. Epub 2024 Apr 17. Endocrine. 2024. PMID: 38632163 Review.
-
Treatment of Hypoparathyroidism by Re-Establishing the Effects of Parathyroid Hormone.Endocrinol Metab (Seoul). 2024 Apr;39(2):262-266. doi: 10.3803/EnM.2024.1916. Epub 2024 Apr 4. Endocrinol Metab (Seoul). 2024. PMID: 38572533 Free PMC article. Review.
-
Continuous Subcutaneous Delivery of rhPTH(1-84) and rhPTH(1-34) by Pump in Adults With Hypoparathyroidism.J Endocr Soc. 2024 Mar 29;8(5):bvae053. doi: 10.1210/jendso/bvae053. eCollection 2024 Mar 12. J Endocr Soc. 2024. PMID: 38562130 Free PMC article.
References
-
- Langdahl BL, Mortensen L, Vesterby A, Eriksen EF, Charles P. 1996. Bone Histomorphometry in hypoparathyroid patients treated with vitamin D. Bone 18:103–108 - PubMed
-
- Weber G, Cazzuffi MA, Frisone F, de Angelis M, Pasolini D, Tomaselli V, Chiumello G. 1988. Nephrocalcinosis in children and adolescents: sonographic evaluation during long-term treatment with 1,25-dihydrocholecalciferol. Child Nephrol Urol 9:273–276 - PubMed
-
- Santos F, Smith MJ, Chan JC. 1986. Hypercalciuria associated with long term administration of calcitriol (1,25-dihydroxyvitamin D). Am J Dis Child 140:139–142 - PubMed
-
- Litvak J, Moldwer MP, Forbes AP, Henneman PH. 1958. Hypocalcemic hypercalciuria during vitamin D and dihydrotachysterol therapy of hypoparathyroidism. J Clin Endocrinol Metab 18:246–252 - PubMed
Publication types
MeSH terms
Substances
Grants and funding
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical