Clinical trial · Interventional
Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
Assessment of the Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metastases-related Pain in Patients With Prostate Cancer
NCT00375648CI-TRIAL-00027952TRAPEZEcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the efficacy and safety of 4 mg zoledronic acid administered intravenously every 3-4 weeks in the treatment of bone metastases-related pain in patients with prostate cancer.
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 |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- zoledronate
- interventionNames
- Drug: Zoledronic acid
Primary outcomes (1)
- measure
- to measure the intensity of the pain relief of the patients at the end of treatment with a five classes score (TOTPAR = TOTal PAin Relief)
- timeFrame
- at 12 weeks or at 16 weeks (end of treatment)
Secondary outcomes (8)
- measure
- To measure the intensity of the pain relief of the patients with the PAR at each visit
- timeFrame
- every 3 or 4 weeks during 12 to 16 weeks
- measure
- To evaluate the pain variation with VAS between V1 and V2, V3, V4, V5.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven adenocarcinoma of the prostate * Bone-scan documented metastases * Age \> 18 years * Non-controlled bone pain despite systemic anti-tumor therapy (hormone or chemotherapy) initiated at least 4 weeks before inclusion * Life expectancy \> 3 months * Written informed consent Exclusion Criteria: * New systemic anti-tumor therapy initiated less than 4 weeks before study entry or predictable need for starting a new treatment within 8 weeks * Radiation therapy on bone target lesions or bone-targeted isotope therapy (strontium or samarium) completed less than 4 weeks before study entry * Bisphosphonate therapy within 8 weeks before study entry * Abnormal renal function (serum creatinine \> 2 x the upper normal limit or creatinine clearance \< 30 ml/min) * Corrected serum calcium \> 3 mmol/L or \< 2 mmol/L * Clinically relevant hypersensitivity to zoledronic acid, or another bisphosphonate, or one component present in the formulation of the study drug * Severe concomitant medical condition that could hamper patient's quality of life or influence the interpretation of pain * Patients unable to fill in a questionnaire (neurologic or psychiatric conditions, illiteracy, etc.) Other protocol-defined exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.