A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism

PHASE4CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

October 27, 2016

Primary Completion Date

December 20, 2019

Study Completion Date

December 20, 2019

Conditions
Chronic HypoparathyroidismHypoparathyroidism
Interventions
DRUG

rhPTH(1-84)

Participants will receive 25, 50, 75, and 100 microgram (mcg) of rhPTH(1-84) subcutaneous injection to the thigh via a multidose pen injector device once daily for 36 months. The dose will be individualized based on Albumin-corrected Serum Calcium (ACSC) and 24-hour calcium urinary excretion to achieve a serum calcium level in the lower half of the normal range.

Trial Locations (1)

10032

Columbia University Medical Center, New York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY