Chronic hypoparathyroidism and treatment with teriparatide.

Affiliation

Marcucci G(1), Masi L(2), Cianferotti L(1), Giusti F(1), Fossi C(1), Parri S(1), Gronchi G(3), Brandi ML(4).
Author information:
(1)Bone Metabolic Diseases Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, University Hospital of Florence, Florence, Italy.
(2)Bone Metabolic Diseases Unit, University Hospital of Florence, Florence, Italy.
(3)Department of Neurosciences, Psychology, Drug Research, and Child Health, University of Florence, Florence, Italy.
(4)Bone Metabolic Diseases Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, University Hospital of Florence, Florence, Italy. [Email]

Abstract

PURPOSE: Chronic hypoparathyroidism is usually treated with calcium and active vitamin D metabolites or analogs, despite the fact that their chronic use can lead to long-term complications. The use of hormone replacement therapy with PTH peptides [teriparatide and rhPTH (1-84)] has therefore been proposed. The main purpose of this study was to investigate the efficacy of teriparatide dose at 20 µg once or twice daily, in order to maintain normocalcemia reducing standard treatment, in adult patients with chronic hypoparathyroidism not well controlled with conventional treatment. METHODS: The study was a Phase III, open-label, non-comparative, clinical investigation (study period: 3 months), at a tertiary care clinical research center. Thirty patients with chronic hypoparathyroidism were screened, and 12 started teriparatide. After the optimization phase (0-4 weeks), calcium and calcitriol supplements were progressively reduced, while teriparatide 20 µg once daily was administered (5-7 weeks), and then could be titrated up to 20 µg twice daily (7-17 weeks). The main outcome measures included serum and urinary biochemical exams and Rand 36-Item Short Form Health Survey. RESULTS: This study showed that teriparatide 20 µg once daily was insufficient to discontinue calcium and calcitriol supplements to maintain normal serum calcium concentrations. Conversely, for more than half of patients treated with teriparatide 20 µg twice daily, calcium and calcitriol administration was avoidable, but in some cases at the expense of serum calcium and phosphate oscillations. CONCLUSIONS: Since intervention trials evaluating the efficacy and safety of teriparatide in hypoparathyroid patients are not yet available, the routine use of this molecule poses some doubts.