Clinical Trial: A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary

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

Official Title: A 6-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypopara

Brief Summary: This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in reducing requirements for supplemental oral calcium and active vitamin D, while maintaining stable total serum calcium levels in adult subjects with hypoparathyroidism.

Detailed Summary: Subjects either must have previously completed NPSP558 Study CL1-11-040 (REPLACE) including 24 weeks of active therapy and 4 weeks of follow-up to Week 28 prior to enrolling in this study or have enrolled in REPLACE and dropped out during optimization, but currently meet inclusion/exclusion criteria for REPLACE.
Sponsor: Shire

Current Primary Outcome: Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 24, Based on Investigator Prescribed Data. [ Time Frame: 24 Weeks ]

A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.


Original Primary Outcome:

  • A ≥ 50% reduction from baseline in dose of oral calcium supplementation or an oral calcium dose of ≤ 500 mg/day [ Time Frame: 6 months ]
  • A ≥ 50% reduction from baseline in dose of oral calcitriol/alphacalcidol supplementation or an oral calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day [ Time Frame: 6 months ]
  • A total serum calcium concentration that is normalized or maintained compared to the baseline value and does not exceed the ULN for the central laboratory [ Time Frame: 6 months ]


Current Secondary Outcome:

  • Mean Percentage Changes From Baseline in Active Vitamin D Dosages at Each Visit [ Time Frame: 24 Weeks ]
  • Mean Percentage Changes From Baseline in Oral Calcium at Each Visit [ Time Frame: 24 Weeks ]
  • Proportion of Patients Achieving the Primary Endpoint at Each Visit [ Time Frame: 24 Weeks ]
    A ≥ 50% reduction from baseline in dose of oral calcium or an oral calcium dose of ≤ 500 mg and a ≥ 50% reduction from baseline in dose of oral active vitamin D (calcitriol dose of ≤ 0.25 μg/day or alphacalcidol dose of ≤ 0.50 μg/day) and a total serum calcium concentration that was normalized or maintained compared to the baseline value and did not exceed the ULN of the central laboratory.
  • Mean Change From Baseline in 24-hour Urine Calcium Excretion [ Time Frame: 24 Weeks ]


Original Secondary Outcome:

  • Mean percentage changes from baseline in supplemental oral calcium and supplemental calcitriol or alphacalcidol dosages at each visit [ Time Frame: 6 months ]
  • Proportion of patients achieving the primary endpoint at each visit [ Time Frame: 6 months ]
  • Mean Change From Baseline in 24-hour Urine Calcium Excretion [ Time Frame: 6 months ]


Information By: Shire

Dates:
Date Received: September 15, 2011
Date Started: August 2011
Date Completion:
Last Updated: November 10, 2015
Last Verified: March 2015