Use of NPSP558 in the Treatment of Hypoparathyroidism

Phase 3

Completed

• Conditions: Hypoparathyroidism
• Interventions: Drug: Placebo; Drug: NPSP558

• Registration Number: NCT00732615
• Lead Sponsor: Shire

Brief 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.

Study Timeline

• Study First Submitted: 2008-08-08
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Study Start: 2008-12-18
• Primary Completion: 2011-09-28
• Study Completion: 2011-09-28
• Disposition First Submitted: 2012-10-09
• Disposition First Submitted QC: 2012-10-09
• Disposition First Posted: 2012-10-11
• Results First Submitted: 2015-02-20
• Results First Submitted QC: 2015-02-20
• Results First Posted: 2015-03-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Sterile water for injection
50, 75, 100 mcg NPSP558	NPSP558	Initial dose of 50mcg, to be titrated up to 75mcg and then 100mcg dependent upon response

Primary Outcome Measures

Name	Time	Method
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24.	Week 24 of dosing	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Achieved Independence From Active Vitamin D and an Oral Calcium Dose of ≤ 500 mg/Day at Week 24.	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.	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.
Percentage Changes From Baseline in Daily Calcium Dose at Week 24.	24 Weeks	The analysis of this endpoint was based on investigator prescribed data.

Trial Locations

Locations (31)

Mayo Clinic-Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Advance Medical Research LLC; 🇺🇸 Lakewood, California, United States

Diabetes Associates; 🇺🇸 Orange, California, United States

University of California-San Francisco VA Medical Center; 🇺🇸 San Francisco, California, United States

Palm Springs Research Institute; 🇺🇸 Hialeah, Florida, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Michigan Bone and Mineral Clinic PC; 🇺🇸 Detroit, Michigan, United States

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