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
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
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to occurrence of first bone metastasis, as assessed by bone scan and confirmed by additional radiological examination
Bobak Djavan, Prof
Principal Investigator
Univ. Klinik für Urologie
Austria: Federal Ministry for Health and Women
CECOG/prostate 1.2.001
NCT00294437
December 2003
November 2007
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