Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050011
Status:
COMPLETED
Last Update Posted:
2014-03-21
First Post:
2002-11-18
Brief Title:
Zoledronic Acid - Letrozole Adjuvant Synergy Trial ZFAST - Cancer Treatment Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive andor Progesterone Receptor Positive Breast Cancer Receiving Adjuvant Hormonal Therapy
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open-Label Randomized Multicenter Study to Evaluate the Use of Zoledronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Receptor Positive andor Progesterone Receptor Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy
Status:
COMPLETED
Status Verified Date:
2014-02
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:
This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start based on a post-baseline BMD T- Score below -20 SD at either the lumbar spine or total hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit in stage I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive Letrozole 25 mg daily as an adjuvant therapy
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