Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Multicenter Retro-Prospective Observational Study on Chronic Hypoparathyroidism and rhPTH (1-84) Treatment

Version 1 : Received: 22 December 2021 / Approved: 24 December 2021 / Online: 24 December 2021 (23:55:38 CET)

How to cite: Marcucci, G.; Beccuti, G.; Carosi, G.; Cetani, F.; Cianferotti, L.; Colao, A.M.; Di Somma, C.; Duradoni, M.; Elefante, A.; Ghizzoni, L.; Giusti, M.; Lania, A.G.; Lavezzi, E.; Madeo, B.; Mantovani, G.; Marcocci, C.; Masi, L.; Parri, S.; Pigliaru, F.; Santonati, A.; Spada, A.; Vera, L.; Brandi, M.L. Multicenter Retro-Prospective Observational Study on Chronic Hypoparathyroidism and rhPTH (1-84) Treatment. Preprints 2021, 2021120415 (doi: 10.20944/preprints202112.0415.v1). Marcucci, G.; Beccuti, G.; Carosi, G.; Cetani, F.; Cianferotti, L.; Colao, A.M.; Di Somma, C.; Duradoni, M.; Elefante, A.; Ghizzoni, L.; Giusti, M.; Lania, A.G.; Lavezzi, E.; Madeo, B.; Mantovani, G.; Marcocci, C.; Masi, L.; Parri, S.; Pigliaru, F.; Santonati, A.; Spada, A.; Vera, L.; Brandi, M.L. Multicenter Retro-Prospective Observational Study on Chronic Hypoparathyroidism and rhPTH (1-84) Treatment. Preprints 2021, 2021120415 (doi: 10.20944/preprints202112.0415.v1).

Abstract

The use of recombinant human PTH (1-84) [rhPTH(1-84)] is approved as hormonal replacement therapy in patients with hypoparathyroidism not adequately controlled with conventional therapy. The objective of this study was to investigate the effects of 12 months of rhPTH (1-84) treatment in a cohort of patients selected according to the indications of recent hypoparathyroidism guidelines. It is a multicenter, observational, retro-prospective, open label study. Eleven Italian Endocrinological centers were involved. Fourteen adult subjects with chronic hypoparathyroidism treated with rhPTH (1-84) for 12 months were enrolled. Main outcome measures included serum and urinary parameters of mineral metabolism, renal function, oral calcium and vitamin D doses, and clinical manifestations. At 12 months, 61.5% of patients discontinued calcium supplement and 69.2% calcitriol. Mean serum calcium levels quickly normalized after initiation of rhPTH (1-84) treatment compared to baseline (p=0.009). Rare hypo-hypercalcemia episodes were reported. Renal function was maintained normal and no renal complications were reported. Serum and urinary phosphate and urinary calcium were maintained in the normal range. Mean phosphatemia levels linearly decreased from 3 months up to 12 months compared to baseline (p= 0.014). No severe adverse events were described. In conclusion, this study confirm the efficacy and safety of rhPTH (1-84) therapy.

Keywords

Chronic Hypoparathyroidism; rhPTH (1-84); Natpar®; Treatment

Subject

MEDICINE & PHARMACOLOGY, Other

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