Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03164928
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2017-05-08
Brief Title:
Safety and Efficiency of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Parallel-group Study to Evaluate the Safety and Efficacy of Denosumab in Pediatric Subjects With Glucocorticoid-induced Osteoporosis
Status:
COMPLETED
Status Verified Date:
2024-07
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:
To evaluate the effect of denosumab on lumbar spine bone mineral density BMD Z-score as assessed by dual-energy X-ray absorptiometry DXA at 12 months in children 5 to 17 year of age with Glucocorticoid GC-induced osteoporosis GiOP
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2016-003083-39 | EUDRACT_NUMBER | None | None |