Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391950
Status:
TERMINATED
Last Update Posted:
2009-11-23
First Post:
2006-10-23
Brief Title:
Maintaining Bone Strength in Men With Prostate Cancer
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
An Open-Label Randomized Multicentre Study to Evaluate the Efficacy of Two Zoledronic Acid Schedules on Bone Mineral Density in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Status:
TERMINATED
Status Verified Date:
2009-11
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 purpose of this study is to see if giving zoledronic acid three times a year is as effective as five times a year in increasing bone strength in men with prostate cancer All participants will receive the active drug but half will receive drug every 6 months and the other half will receive drug every 3 months Both patient and doctor will know which treatment a patient is receiving
After 1 year of treatment bone strength will be measured with scans and compared to the strength at the start of the study All participants will stop receiving the drug after 1 year and will be seen back in the clinic annually for another 2 years for follow-up
After 1 year of treatment bone strength will be measured with scans and compared to the strength at the start of the study All participants will stop receiving the drug after 1 year and will be seen back in the clinic annually for another 2 years for follow-up
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