Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.
Patients with a history of Hypoparathyroidism will be randomized to receive study drug for 8 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.
Advance Medical Research LLC
Lakewood, California, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.
The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.
Time frame: 8 Weeks
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.
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
Time frame: 8 Weeks
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Massachusetts General Hospital
Boston, Massachusetts, United States
Michigan Bone & Mineral Clinic PC
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
University Physicians Group
Staten Island, New York, United States
Physician East PA
Greenville, North Carolina, United States
University of Cincinnati Bone Health and Osteoporosis Center
Cincinnati, Ohio, United States
...and 2 more locations