Clinical trial · Interventional
Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases
A Multicenter, Open-label Study to Determine the Effect of iv. Zoledronic Acid on Pain and Quality of Life in Patients With Bone Metastases With or Without Skeletal Related Events (SRE) Resulting From Breast Cancer and Prostate Cancer
NCT00434317CI-TRIAL-00026065completedPhase 4ClinicalTrials.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 safety, tolerability and efficacy of zoledronic acid administered intravenously every 3-4 weeks in patients with bone metastases from either breast cancer or 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 |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zoledronic acid | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZOL446
- interventionNames
- Drug: Zoledronic acid
Primary outcomes (1)
- measure
- Measurement of pain assessed by a Visual Analogue Scale (VAS)
- timeFrame
- throughout the study
Secondary outcomes (1)
- measure
- Quality of Life assessment at baseline and last visit
- timeFrame
- throughout the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Ambulatory patients \>18 years * Proof of breast cancer or prostate cancer * Diagnosis of at least one cancer-related bone lesion that is detectable on conventional radiographs or bone scan at screening * Negative pregnancy test * ECOG performance status of 0,1 or 2 Exclusion criteria: * Patients with abnormal renal function * Patients with clinically symptomatic brain metastases * Known hypersensitivity on zoledronic acid or other bisphosphonates * Pregnancy or lactation Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.