Conditions: Hypoparathyroidism
Keywords: Hypoparathyroidism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 124
Healthy volunteers: no

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.

Arms:
arm 1: Sterile water for injection arm 2: Initial dose of 50mcg, to be titrated up to 75mcg and then 100mcg dependent upon response

Interventions: intervention 1: Placebo intervention 2: NPSP558
Intervention descriptions: intervention 1: Placebo for subcutaneous injection intervention 2: Parathyroid hormone 50, 75, or 100 mcg injectable subcutaneously daily

Protocol document: