This trial is active, not recruiting.

Condition hypoparathyroidism
Treatment npsp558
Phase phase 3
Sponsor Shire
Start date April 2011
End date December 2016
Trial size 40 participants
Trial identifier NCT01297309, PAR-C10-008


This study is a 12-month, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
titration of 25, 50, 75 or 100 μg
npsp558 RACE
All patients will inject NPSP558 individual titration of 25, 50, 75 or 100 μg SC QD into alternating thighs in the morning via a multidose injection pen device.

Primary Outcomes

A reduction in oral calcium or an oral calcium dose of ≤ 500 mg
time frame: 52 weeks of treatment, 4 weeks of follow-up
A reduction in oral calcitriol to ≤ 0.25 μg
time frame: 52 weeks of treatment, 4 weeks of follow-up
An albumin-corrected total serum calcium concentration that is normalized or maintained compared to the baseline value (≥7.5 mg/dL) and ULN
time frame: 52 weeks of treatment, 4 weeks of follow-up

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

Inclusion Criteria: 1. Diagnosis of Hypoparathyroidism ≥ 18 months 2. Adult males and females ages 18 to 85 years of age 3. Able to perform daily SC self-injections of study medication 4. Previously completed a NPSP558 study 5. Women of childbearing potential need to use two methods of contraception. Exclusion Criteria: 1. Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of PTH 1-84 and/or completing this trial 2. Pregnant or lactating woman.

Additional Information

Official title A Long-term Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)
Description Patients with a history of Hypoparathyroidism will be enrolled to receive study drug for 52 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Shire.