Clinical trial · Interventional
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
NCT00294437CI-TRIAL-00006827terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): underfunding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zometa | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- zoledronic acid
- description
- Zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months
- interventionNames
- Drug: Zometa
- type
- NO_INTERVENTION
- label
- no intervention
- description
- no reference therapy
Primary outcomes (1)
- measure
- Time to occurrence of first bone metastasis, as assessed by bone scan and confirmed by additional radiological examination
Secondary outcomes (7)
- measure
- 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:
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.