Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043186
Status:
COMPLETED
Last Update Posted:
2013-09-18
First Post:
2002-08-06
Brief Title:
Determine the Efficacy Safety and Tolerability of Denosumab AMG 162 in the Treatment of Postmenopausal Women With Low Bone Mineral Density
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Randomized Double-Blind Placebo-controlled Multi-dose Phase 2 Study to Determine the Efficacy Safety and Tolerability of AMG 162 in the Treatment of Postmenopausal Women With Low Bone Mineral Density
Status:
COMPLETED
Status Verified Date:
2013-09
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 determine the effect of denosumab treatment compared with placebo over 12 months on bone mineral density BMD of the lumbar spine in postmenopausal women with low BMD The clinical hypothesis is that denosumab subcutaneous injections administered every 3 or 6 months for 12 months will significantly increase lumbar spine bone mineral density and will be well tolerated
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