Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2026-01-11 @ 10:54 PM
Study NCT ID:
NCT02099461
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2014-02-25
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Denosumab on Cellular Biomarkers in the Human Breast
Sponsor:
Amgen
Organization:
Study Overview
Official Title:
A Randomized, Stratified, Open-label, No-treatment-controlled, Parallel Group, Multicenter Phase 1 Trial to Evaluate the Effect of Denosumab on Cellular Proliferation in the Human Breast
Status:
COMPLETED
Status Verified Date:
2015-08
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 whether administration of denosumab results in a decrease compared to the control group in proliferation of mammary epithelial cells as measured by the Ki-67 proliferation index.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: