NCT00294437

ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 376 (actual)
• Sponsor: Central European Cooperative Oncology Group · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 p.o. qd Arm A: Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months Arm B: no reference therapy

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Zometa	Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months

Timeline

• Start date: 2003-12-01
• Primary completion: 2003-12-01
• Completion: 2007-11-01
• First posted: 2006-02-22
• Last updated: 2012-05-01

Locations

57 sites across 16 countries: Austria, Bosnia and Herzegovina, Bulgaria, Croatia, Czechia, Estonia, Hungary, Lithuania, Montenegro, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa