Clinical Trial: Use of NPSP558 in the Treatment of Hypoparathyroidism

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

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With 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 Primary Outcome: Reduction of calcium and vitamin D supplements [ Time Frame: Week 24 of dosing ]

Current Secondary Outcome:

  • Percentage Changes From Baseline in Daily Calcium Dose at Week 24. [ Time Frame: 24 Weeks ]
    The analysis of this endpoint was based on investigator prescribed data.
  • Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24. [ Time Frame: 24 Weeks ]
    Subjects Who Achieved Independence from Active Vitamin D Usage and with Calcium Dose of 500 mg/day or less. This analysis was based on Investigator Prescribed Data.
  • Percentage of Subjects With Any Clinical Symptoms of Hypocalcemia During Weeks 16-24. [ Time Frame: 8 Weeks ]
    Clinical symptoms were a selected group of adverse events that occurred during study weeks 16 through 24. The group of terms were defined by key opinion leaders and documented in study protocol.


Original Secondary Outcome:

Information By: Shire

Dates:
Date Received: August 8, 2008
Date Started: December 2008
Date Completion:
Last Updated: November 10, 2015
Last Verified: March 2015