Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082277
Status:
COMPLETED
Last Update Posted:
2011-01-26
First Post:
2004-05-05
Brief Title:
Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Multicentre Phase IIIIV Study of the Effects of Risedronate Sodium ACTONEL 35mgWeek Oral on Bone in Postmenopausal Women With Hormone-receptor-positive Early Breast Cancer Treated With Anastrozole ARIMIDEX 1mgDay Oral With Risk of Fragility Fracture High-risk Fragility Fracture-open-label Non-comparative Stratum Moderate-risk of Fragility Fracture-randomised Double-blind Stratum Low-risk of Fragility Fracture - Open-label Non-comparative StratumAbbreviated
Status:
COMPLETED
Status Verified Date:
2011-01
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:
SABRE
Brief Summary:
The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture It is also conducted to determine the effects of anastrozole on bone mineral density BMD and on bone metabolism in women at low risk of fragility fracture
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 |
|---|---|---|---|
| SABRE | None | None | None |