Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004406
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis
Sponsor:
Columbia University
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
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:
OBJECTIVES
I Determine the effect of human parathyroid hormone 1-34 on bone mass in middle-aged men with idiopathic osteoporosis
I Determine the effect of human parathyroid hormone 1-34 on bone mass in middle-aged men with idiopathic osteoporosis
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled study All patients self-administer daily subcutaneous injections of human parathyroid hormone 1-34 or placebo for a period of 25 years
Patients are followed regularly for unacceptable toxicities
Completion date provided represents the completion date of the grant per OOPD records
Patients are followed regularly for unacceptable toxicities
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPS-CU-FDR001024 | None | None | None |