Use of NPSP558 in the Treatment of Hypoparathyroidism (REPLACE)

Use of PTH (1-84) a recombinant hormone in escalating doses for the treatment of adults with hypoparathyroidism. The use of PTH should result in a decrease of calcium and vitamin D supplements.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Hypoparathyroidism
Enrollment: 124
Study Start Date: December 2008
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Arms:
- Placebo Comparator: Placebo
- Experimental: 50, 75, 100 mcg NPSP558