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Clinical Trials/NCT00434317
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

Novartis1 site in 1 country80 target enrollmentStarted: August 2005Last updated:
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

Sponsor
Novartis
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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