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NCT00434317 Clinical Trial

Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases

Neoplasm Metastasis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00434317
Other study ID # CZOL446EHU03
Secondary ID
Status Completed
Phase Phase 4
First received February 9, 2007
Last updated February 21, 2017
Start date August 2005

Study information
Verified date February 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date
Est. primary completion date April 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Zoledronic acid

Locations
Country Name City State
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Pecs
Hungary Novartis Investigative Site Szeged
Hungary Novartis Investigative Site Szekesfehervar

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement of pain assessed by a Visual Analogue Scale (VAS) throughout the study
Secondary Quality of Life assessment at baseline and last visit throughout the study
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