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
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Neoplasm Metastasis
Both
Neoplasm Metastasis
Trial Information
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
Inclusion Criteria
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Measurement of pain assessed by a Visual Analogue Scale (VAS)
Outcome Time Frame:
throughout the study
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Hungary: National Institute of Pharmacy
Study ID:
CZOL446EHU03
NCT ID:
NCT00434317
Start Date:
August 2005
Completion Date:
Related Keywords:
- Neoplasm Metastasis
- Metastasis
- Neoplasm
- pain
- breast cancer
- prostate cancer
- bone metastasis
- Breast Neoplasms
- Neoplasms
- Neoplasm Metastasis
- Neoplasms, Second Primary
- Prostatic Neoplasms
- Bone Neoplasms
- Bone Marrow Diseases
Name | Location |
|---|
