ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases
NCT ID: NCT00294437
Last Updated: 2012-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
376 participants
INTERVENTIONAL
2003-12-31
2007-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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zoledronic acid
Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
Zometa
Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
no intervention
no reference therapy
No interventions assigned to this group
Interventions
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Zometa
Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years
* Histologically confirmed diagnosis of carcinoma of the prostate
* ECOG performance status of 0, 1, or 2
* No radiological evident bone metastasis (negative bone scan or verification of suspected foci as benign lesions by additional radiological examination)
* T3-4 AND highest pre-study PSA \>20 ng/ml AND Gleason score = 8 (or Gleason grade = 4)
* Patients with prior prostatectomy or prior local radiotherapy are eligible for this study
* Patients are destined to receive medical (LHRH analogue) or surgical (orchiectomy) castration and Zometa® treatment will start not later than 6 weeks after surgery
* Patients should be fully recovered from prior interventions where applicable
Exclusion Criteria
* Patients that received prior medical (LHRH analogue) castration
* Current (or previous) evidence of metastatic disease to the bone
* History of any other neoplasm within the past five years except for nonmelanomatous skin cancer.
* Previous hormonal therapy with LHRH agonists or other forms of hormonal ablation
* WBC\<3.0x109, ANC \< 1500/mm3, Hgb\<8.0 g/dL, platelets \< 75 x 109/L
* Liver function tests \>2.5 ULN
* Prior treatment with Zometa® (zoledronic acid) or other bisphosphonates
* Treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to the date of randomization (Visit 2)
* Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of randomization (Visit 2)
* Patients with evidence in the six months prior to randomization of severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or symptomatic coronary artery disease uncontrolled by treatment
* History of noncompliance to medical regimens and patients who are considered potentially unreliable or incapable of giving informed consent as judged by the investigator.
18 Years
MALE
No
Sponsors
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Central European Cooperative Oncology Group
OTHER
Responsible Party
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CECOG
Principal Investigators
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Bobak Djavan, Prof
Role: PRINCIPAL_INVESTIGATOR
Univ. Klinik für Urologie
Locations
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LKH Leoben, Abt. für Innere Medizin
Leoben, Styria, Austria
Thermenkh Baden, Urologie
Baden, , 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
Oncological Hospital
Varna, , Bulgaria
Modozs-Veliko
Veliko Tarnovo, , Bulgaria
Univ. Hospital, Dep of Pathophysiology
Split, , Croatia
GH, Dep Oncology and Reumatology
Varaždin, , Croatia
Clinical Hospital
Zagreb, , Croatia
FH, Urological Clinic
Brno, , Czechia
Hospital Kromeriz, Dep of Urology
Kroměříž, , Czechia
FN Motol, Dep of Urology
Prague, , Czechia
Centre of Oncology
Ústí nad Labem, , Czechia
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
Pécs, , 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
Iași, , Romania
Hertzen Research Oncological Institute
Moscow, , Russia
Medical Radiological Research Center
Obninsk, , Russia
Clinical Center of Serbia
Belgrade, , Serbia
Oncology Institute Belgrade
Belgrade, , Serbia
Oncology Institute
Belgrade, , Serbia
Institute for Oncology
Kamenitz, , Serbia
Clinical Center
Niš, , Serbia
FNsP - akad L. Derea Urology
Bratislava, , Slovakia
FNsP Dep of Urology
Košice, , 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
Countries
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Related Links
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Related Info
Other Identifiers
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CECOG/prostate 1.2.001
Identifier Type: -
Identifier Source: org_study_id
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