Endocrine Abstracts

Hypoparathyroidism is a rare endocrine deficiency due to inadequate amounts of parathyroid hormone (PTH) and is characterised by hypocalcaemia and hyperphosphataemia. Current management regimens with large amounts of oral calcium and active vitamin D do not adequately control mineral homeostasis and can lead to complications in many patients. The phase III REPLACE and RELAY clinical trials established the efficacy and safety of once-daily s.c. injection of r...

Background: RACE is an open-label study that assessed the long-term safety and efficacy of recombinant human parathyroid hormone 1–84 (rhPTH[1–84]) for the treatment of hypoparathyroidism in adults (ClinicalTrials.gov identifier NCT01297309). Here, we present 6-year safety and efficacy data.Methods: Patients initially received 25 or 50 μg of rhPTH(1–84) subcutaneously, once daily, with stepwise dose adjustments of 25 μg (up or do...

Hypoparathyroidism (HPT) is characterised by hypocalcaemia and impaired renal phosphate excretion and calcium conservation. Oral calcium supplements and calcitriol can improve serum calcium levels but lack the physiologic effects of PTH on renal reabsorption of calcium. RACE is an ongoing open-label study evaluating the long-term safety of recombinant human parathyroid hormone 1-84 (rhPTH[1-84], parathyroid hormone rDNA) in adults with HPT (NCT01297309). In this interim analys...

PARADIGHM™, a global, prospective, observational registry of patients with chronic hypoparathyroidism (HPT), began enrolment in 2013 to collect data on the natural history of chronic HPT (ClinicalTrials.gov NCT01922440). Since initiation, recombinant human PTH, rhPTH(1-84), has been approved in the United States and Europe as an adjunctive treatment for adult patients with HPT. The protocol for the registry (now a European Medicines Agency–designated postm...

Hypoparathyroidism is a disorder of mineral homoeostasis due to parathyroid hormone (PTH) deficiency. Conventional treatment with oral Ca and calcitriol may maintain serum Ca levels but does not replace other physiologic PTH effects. RACE is an ongoing open-label study of recombinant human PTH1-84 (rhPTH1-84) for hypoparathyroidism treatment in adults (ClinicalTrials.gov NCT01297309). Patients initially received rhPTH1-84 25 or 50 μg/day subcutaneously, with 25-μg in...

PARADIGHM is an actively recruiting, prospective, observational registry (NCT01922440/EUPAS16927). The primary objective is to evaluate the safety and effectiveness of recombinant human parathyroid hormone, rhPTH(1-84), treatment in patients with chronic hypoparathyroidism under routine clinical care. The secondary objective is tocharacterize the clinical course of chronic hypoparathyroidism under conditions of routine clinical practice. At enrollment, registry inclusion crite...

Pseudohypoparathyroidism (PHP) and related disorders lead to a wide spectrum of abnormal physical characteristics, neurocognitive and endocrine abnormalities that share a common PTH/PTHrP signaling pathway. The clinical and molecular overlap of PHP and related disorders lead to difficulties in clinical and molecular diagnosis which prompt to the possibility of incorrect management of these patients. PHP (including all subtypes), pseudoPHP, acrodysostosis and progressive osseou...