Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00294437
Status:
TERMINATED
Last Update Posted:
2012-05-01
First Post:
2006-02-20
Brief Title:
ZOMETA Zoledronic Acid for Prevention of Bone Metastases
Sponsor:
Central European Cooperative Oncology Group
Organization:
Central European Cooperative Oncology Group
Study Overview
Official Title:
Randomised Open-label Multicenter Prosp Clinical Study to Show the Efficacy of IV ZOMETA 4mg for Prevention of Bone Metastases in Hormone-naïve High Risk Patients With Locally Advanced Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
underfunding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine if therapy with Zometa zoledronic acid 4mg will be effective in preventing the occurrence of bone metastases in prostate cancer patients at high risk of developing them In addition pain and analgesic scores and overall safety are to be evaluated throughout the study
Detailed Description:
This is a prospective randomized stratified open-label Zometa hormonal ablation versus hormonal ablation alone multicenter clinical study evaluating the efficacy of Zometa 4mg given every 3 month as an adjunct to hormonal or surgical castration for prevention of bone metastases in locally advanced high risk prostate cancer patients who are hormone-naiv at time of randomization the primary efficacy variable is the time to occurrence of first bone metastases
Zometa zoledronic acid provided as 4mg lyophilised powder Supplementation 500mg Calcium 400-500IU Vitamin D po qd
Arm A
Zometa zoledronic acid in 100ml of calcium free solution iv as a 15 minute infusion every 3 months
Arm B
no reference therapy
Zometa zoledronic acid provided as 4mg lyophilised powder Supplementation 500mg Calcium 400-500IU Vitamin D po qd
Arm A
Zometa zoledronic acid in 100ml of calcium free solution iv as a 15 minute infusion every 3 months
Arm B
no reference therapy
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