NCT00434317CompletedPhase 4
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Measurement of pain assessed by a Visual Analogue Scale (VAS)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ZOL446
Experimental
Intervention: Zoledronic acid (Drug)
Outcomes
Primary Outcomes
Measurement of pain assessed by a Visual Analogue Scale (VAS)
Time Frame: throughout the study
Secondary Outcomes
- Quality of Life assessment at baseline and last visit(throughout the study)
Investigators
Study Sites (1)
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