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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 24. [ Time Frame: Week 24 of dosing ] [ Designated as safety issue: No ]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.
- Percentage Changes From Baseline in Daily Calcium Dose at Week 24. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||December 2008|
|Study Completion Date:||November 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Sterile water for injection
Placebo for subcutaneous injection
Experimental: 50, 75, 100 mcg NPSP558
Initial dose of 50mcg, to be titrated up to 75mcg and then 100mcg dependent upon response
Parathyroid hormone 50, 75, or 100 mcg injectable subcutaneously daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732615
Show 31 Study Locations
|Study Director:||Hjalmar Lagast, M.D.||NPS Pharma|