Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306189
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2006-03-21
Brief Title:
A Randomized Double-blind Placebo-controlled Dose Response Study of AMG 162 Denosumab in Japanese Postmenopausal Osteoporotic Subjects
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Dose Response Study of AMG 162 Denosumab in Subjects With Osteoporosis - A Randomized Double-blind Placebo-controlled Dose Response Study of AMG 162 Denosumab in Japanese Postmenopausal Osteoporotic Subjects -
Status:
COMPLETED
Status Verified Date:
2013-06
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:
The primary objective of this study is to assess the effect of AMG 162 denosumab treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested 14 60 and 100 mg SC once every 6 months in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months
Detailed Description:
None
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 |
|---|---|---|---|
| NOT APPRICABLE | None | None | None |