ZOMETA® (Zoledronic Acid) for Prevention of Bone Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00294437
Recruitment Status : Terminated (underfunding)
First Posted : February 22, 2006
Last Update Posted : May 1, 2012
Information provided by:
Central European Cooperative Oncology Group

February 20, 2006
February 22, 2006
May 1, 2012
December 2003
December 2003   (Final data collection date for primary outcome measure)
Time to occurrence of first bone metastasis, as assessed by bone scan and confirmed by additional radiological examination
Same as current
Complete list of historical versions of study NCT00294437 on Archive Site
  • To assess the effects of i.v. Zometa® (zoledronic acid) 4 mg, with respect to the following efficacy parameters as well as safety and tolerability:
  • Effects on pain and analgesic drug consumption, assessed by the composite pain score from BPI (Brief Pain Inventory) for pain and by analgesic score
  • Time to first event of bone pain
  • Time to first occurrence of Skeletal Related Events (SREs), defined as pathologic bone fractures, spinal cord compression, surgery to bone, radiation therapy to bone (including the use of radioisotopes)
  • Proportion of patients in each arm having SRE
  • Serum PSA
  • Overall safety
Same as current
Not Provided
Not Provided
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
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.

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

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
Drug: Zometa
Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
  • Experimental: zoledronic acid
    Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
    Intervention: Drug: Zometa
  • No Intervention: no intervention
    no reference therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2007
December 2003   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent
  • 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 with a serum creatinine determination >265 µmol/L (3.0 mg/dL)
  • 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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Bosnia and Herzegovina,   Bulgaria,   Croatia,   Czech Republic,   Estonia,   Hungary,   Lithuania,   Montenegro,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   South Africa
Former Serbia and Montenegro
CECOG/prostate 1.2.001
Not Provided
Not Provided
Central European Cooperative Oncology Group
Not Provided
Principal Investigator: Bobak Djavan, Prof Univ. Klinik für Urologie
Central European Cooperative Oncology Group
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP