Clinical Trial: Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment

Brief Summary: Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.

Detailed Summary: Patients with a history of Hypoparathyroidism will be randomized to receive study drug for 8 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.
Sponsor: Shire

Current Primary Outcome: Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. [ Time Frame: 8 Weeks ]

The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.


Original Primary Outcome: A reduction in oral calcium supplementation to ≤ 500 mg/day, a reduction in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of normal. [ Time Frame: 8 Weeks of Dosing ]

Current Secondary Outcome: The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8. [ Time Frame: 8 Weeks ]

The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data


Original Secondary Outcome: A ≥ 50% reduction from baseline in oral calcium supplementation, a ≥ 50% reduction from baseline in oral calcitriol supplementation and, an albumin-corrected total serum calcium concentration normalized or maintained compared to baseline value [ Time Frame: 8 Weeks of Dosing ]

Information By: Shire

Dates:
Date Received: December 28, 2010
Date Started: January 2011
Date Completion:
Last Updated: November 10, 2015
Last Verified: March 2015