Therapy of Hypoparathyroidism With PTH(1-84): A Prospective Six Year Investigation of Efficacy and Safety.

ABSTRACT:

Context

Human recombinant (rh)PTH(1-84) was recently approved for the treatment of refractory hypoparathyroidism, based upon a short-term phase 3 clinical trial. Long-term data are needed, because no time limit was placed on the treatment period.

Objective

We studied the effect of long-term rhPTH(1-84) treatment in hypoparathyroidism for up to 6 years.

Design

Prospective open-label study.

Setting

Referral center.

Patients

A total of 33 subjects with hypoparathyroidism.

Interventions

rhPTH(1-84) treatment was initiated at a starting dose of 100 μg every other day for 6 years. Due to the availability of new dosages during the 6-year time period of the study, the dose could be and was adjusted for most patients to a daily dosing regimen.

Main outc

SUBMITTER: Rubin MR 

PROVIDER: S-EPMC4929839 | biostudies-literature | 2016 Jul

REPOSITORIES: biostudies-literature