NCT00732615

Use of NPSP558 in the Treatment of Hypoparathyroidism

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Patients with a history of hypoparathyroidism will be randomized to receive placebo or study drug for 24 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically, calcium levels in the blood and urine). In addition, the patients' intake of Vitamin D and calcium will be measured.

Conditions

• Hypoparathyroidism

Interventions

Type	Name	Description
DRUG	Placebo	Placebo for subcutaneous injection
DRUG	NPSP558	Parathyroid hormone 50, 75, or 100 mcg injectable subcutaneously daily

Timeline

• Start date: 2008-12-18
• Primary completion: 2011-09-28
• Completion: 2011-09-28
• First posted: 2008-08-12
• Last updated: 2021-06-03
• Results posted: 2015-03-06

Locations

31 sites across 8 countries: United States, Belgium, Canada, Denmark, France, Hungary, Italy, United Kingdom