Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00424983
Status:
COMPLETED
Last Update Posted:
2020-12-21
First Post:
2007-01-19
Brief Title:
Study of Zoledronic Acid Administered Monthly Versus Every 3 Months in Multiple Myeloma and Breast Cancer Patients Who Were Treated With Zoledronic Acid the Prior Year
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Stratified Randomized Open-label Multi-center Comparative 2-arm Trial of PK PD and Safety of Zoledronic Acid Infusions Administered Monthly vs Every 3-month in Multiple Myeloma Patients With Malignant Bone Lesions and Breast Cancer Patients With Bone Metastasis Who Have Received 9-12 Doses of Zoledronic Acid Over the Prior Year Amendment 1 Changed the Required Doses to 9-20 But Due to FDA Guidelines the Title Has Not Been Changed
Status:
COMPLETED
Status Verified Date:
2014-09
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:
The primary objective of this study is to investigate the repeat-dose pharmacokinetic PK profile of zoledronic acid when administered every 4 weeks versus every 12 weeks in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 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 |
|---|---|---|---|
| 2007-004719-73 | EUDRACT_NUMBER | None | None |