At a glance
ClinicalIndex Comparison Record- ✓Ages 17–69 years
- ✓Biochemically confirmed hypoparathyroidism
- ✕Pregnant women
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
In Brief
A Phase 2 clinical trial evaluating Synthetic Human Parathyroid Hormone 1-34 and Calcitriol & Calcium for Hypoparathyroidism. Completed, enrolled 27 participants across 1 site.
Detailed Summary
This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism to be managed effectively with the investigational drug, PTH. The primary goals of this study are to (1) provide long-term PTH therapy to patients who do not respond to conventional therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney function and bone mineral density; (3) study and track linear growth and bone accrual in children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone mass and if the timing of this is comparable to normal age-matched healthy controls.
Study Details
Timeline
Interventions
twice daily subcutaneous injections
Twice daily oral calcitriol with 1000 mg Calcium carbonate supplementation