Safety and Efficacy of 5 Years of Treatment With Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism.

ABSTRACT:

Context

Conventional hypoparathyroidism treatment with oral calcium and active vitamin D is aimed at correcting hypocalcemia but does not address other physiologic defects caused by PTH deficiency.

Objective

To evaluate long-term safety and tolerability of recombinant human PTH (1-84) [rhPTH(1-84)].

Design

Open-label extension study; 5-year interim analysis.

Setting

12 US centers.

Patients

Adults (N = 49) with chronic hypoparathyroidism.

Intervention(s)

rhPTH(1-84) 25 or 50 µg/d initially, with 25-µg adjustments permitted to a 100 µg/d maximum.

Main outcome measure(s)

Safety parameters; composite efficacy outcome was the proportion of patients with ≥50% reduction in oral calcium (or ≤500 mg/d) and calcitriol (or ≤0.25 µg/d) doses, and album

SUBMITTER: Mannstadt M 

PROVIDER: S-EPMC6760337 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature