Back to resultsAssessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases
Primary Purpose
Neoplasm Metastasis
Status
Completed
Phase
Phase 4
Locations
Hungary
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Metastasis, Neoplasm, pain, breast cancer, prostate cancer, bone metastasis
Eligibility 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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ZOL446
Arm Description
Outcomes
Primary Outcome Measures
Measurement of pain assessed by a Visual Analogue Scale (VAS)
Secondary Outcome Measures
Quality of Life assessment at baseline and last visit
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00434317
Brief Title
Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis
Keywords
Metastasis, Neoplasm, pain, breast cancer, prostate cancer, bone metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZOL446
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Primary Outcome Measure Information:
Title
Measurement of pain assessed by a Visual Analogue Scale (VAS)
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
Quality of Life assessment at baseline and last visit
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Budapest
Country
Hungary
Facility Name
Novartis Investigative Site
City
Pecs
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szekesfehervar
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
Assessment of Pain and Quality of Life in Breast and Prostate Cancer Patients With Bone Metastases
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