Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001304
Status:
COMPLETED
Last Update Posted:
2015-12-15
First Post:
1999-11-03
Brief Title:
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Vitamin D and its analogs the conventional treatment for hypoparathyroidism are associated with chronic hypercalciuria due to their lack of calcium-retaining effect in the kidney This side effect usually occurs even while maintaining the serum calcium in the normal range and may lead to calcium deposition in the kidney nephrocalcinosis and renal insufficiency This study examines the long-term effects of subcutaneous parathyroid hormone PTH therapy on calcium metabolism bone and renal function Our previous short-term pilot study comparing subcutaneous PTH with calcitriol demonstrated a significant decrease in urinary calcium excretion during PTH therapy Based upon these results we hypothesized that treatment with PTH is more physiologic and provides improved long-term metabolic control Additionally treatment with PTH may avoid the adverse side effects on the kidney that are associated with conventional therapy Patients initially come to the Clinical Center for a two week inpatient evaluation Subsequent follow-up will occur semiannually on an outpatient basis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 92-CH-0011 | OTHER_GRANT | NIH Clinical Center_NICHD | None |