Spots Global Cancer Trial Database for ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases
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Trial Identification
Brief Title: ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases
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
Study ID: NCT00294437
Conditions
Interventions
Study Description
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 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
LKH Leoben, Abt. für Innere Medizin, Leoben, Steiermark, Austria
Thermenkh Baden, Urologie, Baden bei Wien, , Austria
LKH Graz Univ. Klinik f Urologie, Graz, , Austria
LKH Innsbruck, Dept f. Urologie, Innsbruck, , Austria
KH d Elisabethinen Linz, Dep of Urology, Linz, , Austria
KH der Barmherzigen Schwestern, Dept Urologie, Linz, , Austria
LKH Salzburg, Clinic f Radiotherapy a Radiooncology, Salzburg, , Austria
Institute for Oncology, Sarajevo, , Bosnia and Herzegovina
Plovdiv Cancer Center, Plovdiv, , Bulgaria
SBALO National Oncology Center, Sofia, , Bulgaria
SBALO National Oncology Center, Sofia, , Bulgaria
Sofia Cancer Center compl. Mladost ,, Sofia, , Bulgaria
MODOSZ Oncology Dispensary, Stara Zagora, , Bulgaria
Modozs-Veliko, Tarnovo, , Bulgaria
Oncological Hospital, Varna, , Bulgaria
Univ. Hospital, Dep of Pathophysiology, Split, , Croatia
GH, Dep Oncology and Reumatology, Varazdin, , Croatia
Clinical Hospital, Zagreb, , Croatia
FH, Urological Clinic, Brno, , Czech Republic
Hospital Kromeriz, Dep of Urology, Kromeriz, , Czech Republic
FN Motol, Dep of Urology, Prague, , Czech Republic
Centre of Oncology, Usti Nad Labem, , Czech Republic
Mustamae Korpus, Tallinn, , Estonia
Clinic of surgery, Tartu, , Estonia
Dept. Of Urology , Jahn Ferenc Delpesti Hospital, Budapest, , Hungary
karolyi sandor Hospital, Dept of Urology, Budapest, , Hungary
Semmelweiss Univ of Medicine, Clinic of Urology, Budapest, , Hungary
Univ. of Pecs,Urologic Clinic, Pecs, , Hungary
Dept. Of Urology and Surgery, Szombathely, , Hungary
Lithuanian Oncology Center, Vilnius, , Lithuania
Clinical Center of Montenegro, Podgorica, , Montenegro
Centrum Onkologii Instytut, Krakow, , Poland
Medical Academy, Szczecin, , Poland
Central Rail Hospital,, Warsaw, , Poland
Medical Academy, Warsaw, , Poland
P.D.R. Clinic, Brasov, , Romania
Fundeni Hospital, Dep of Urology, Bucharest, , Romania
Saint John Emergency Clinical Hospital, Bucharest, , Romania
Institutul Oncologic Cluj, Cluj-Napoca, , Romania
Emergency Clinical County Hospital , Clin Oncol. Dep, Craiova, , Romania
University Hospital, Iasi, , Romania
Hertzen Research Oncological Institute, Moscow, , Russian Federation
Medical Radiological Research Center, Obninsk, , Russian Federation
Clinical Center of Serbia, Belgrade, , Serbia
Oncology Institute Belgrade, Belgrade, , Serbia
Oncology Institute, Belgrade, , Serbia
Clinical Center, Nis, , Serbia
Institute for Oncology, Sremska Kamenica, , Serbia
FNsP - akad L. Derea Urology, Bratislava, , Slovakia
FNsP Dep of Urology, Kosice, , Slovakia
FN sP Dep of Urology, Martin, , Slovakia
University Clinical Center, Ljubljana, , Slovenia
Gh, Dep of Urology, Maribor, , Slovenia
Turret House, Claremont, , South Africa
Johannesburg Hospital Dep of Urology, Johannesburg, , South Africa
St. Annes Hospital, Pietermaritzburg, , South Africa
Urological Hospital, Pretoria, , South Africa
Contact Details
Name: Bobak Djavan, Prof
Affiliation: Univ. Klinik für Urologie
Role: PRINCIPAL_INVESTIGATOR
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