Use of NPSP558 in the Treatment of Hypoparathyroidism
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124
Not provided
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
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Hillcrest Family Health Center
🇺🇸Waco, Texas, United States
The Vancouver Clinic
🇺🇸Vancouver, Washington, United States
Heritage Medical Research Clinic
🇨🇦Calgary, Alberta, Canada
Capital District Health Authority, QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Oakville Bone Center
🇨🇦Oakville, Ontario, Canada
University of Pécs, School of Medicine
🇭🇺Pécs, Hungary
Chetre Hospitalier Universitaire de Liege
🇧🇪Liege, Belgium
University of Szeged
🇭🇺Szeged, Hungary
Aarhus University Hospital
🇩🇰Aarhus, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
University Hospital of Careggi
🇮🇹Firenze, Italy
Semmelweis University Medical School
🇭🇺Budapest, Hungary
Hôpital Européen Georges Pompidou
🇫🇷Paris, France
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of California-San Francisco VA Medical Center
🇺🇸San Francisco, California, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Palm Springs Research Institute
🇺🇸Hialeah, Florida, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University Physicians Group
🇺🇸Staten Island, New York, United States
Michigan Bone and Mineral Clinic PC
🇺🇸Detroit, Michigan, United States
Physicians East
🇺🇸Greenville, North Carolina, United States
University of Cincinnati Bone Health and Osteoporosis Center
🇺🇸Cincinnati, Ohio, United States
Cetero Research DGD Research Inc.
🇺🇸San Antonio, Texas, United States
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom