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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

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Zometa Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 376 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2003
Actual Primary Completion Date : December 2003
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: zoledronic acid
Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
Drug: Zometa
Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months

No Intervention: no intervention
no reference therapy

Primary Outcome Measures :
  1. Time to occurrence of first bone metastasis, as assessed by bone scan and confirmed by additional radiological examination

Secondary Outcome Measures :
  1. 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:
  2. Effects on pain and analgesic drug consumption, assessed by the composite pain score from BPI (Brief Pain Inventory) for pain and by analgesic score
  3. Time to first event of bone pain
  4. 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)
  5. Proportion of patients in each arm having SRE
  6. Serum PSA
  7. Overall safety

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00294437

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Sponsors and Collaborators
Central European Cooperative Oncology Group
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Principal Investigator: Bobak Djavan, Prof Univ. Klinik für Urologie

Additional Information:
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Responsible Party: CECOG Identifier: NCT00294437    
Other Study ID Numbers: CECOG/prostate 1.2.001
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012
Keywords provided by Central European Cooperative Oncology Group:
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs