Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions
A Prospective, Multicenter, Open-label Clinical Evaluation of the Effect of IV Zoledronic Acid 4mg on PAIN, QUALITY OF LIFE and TIME IN INFUSION CHAIR in Breast Cancer, Multiple Myeloma, and Prostate Cancer Patients With Cancer-related Bone Lesions
1 other identifier
interventional
500
1 country
7
Brief Summary
Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 breast-cancer
Started Oct 2001
Shorter than P25 for phase_4 breast-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
January 9, 2002
CompletedFirst Posted
Study publicly available on registry
January 10, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2002
CompletedFebruary 1, 2012
January 1, 2012
1.1 years
January 9, 2002
January 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain score assessed by change from baseline
Secondary Outcomes (3)
Quality of life
Time in infusion chair
Safety assessed by adverse events (AEs)
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Greater than 18 years of age
- Proof of breast cancer, multiple myeloma or prostate cancer
- Diagnosis of at least one cancer-related bone lesion
- If patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception
- ECOG performance status of 0,1 or 2
- Ability to read, understand and write English or Spanish language
- Normal renal function
You may not qualify if:
- clinically symptomatic brain metastases
- hypersensitivity to Zometa or other bisphosphonates
- pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (7)
Stockton Hematology Oncology Medical Group
Stockton, California, 95204, United States
Osceola Cancer Center
Kissimmee, Florida, 34741, United States
Nevada Cancer Center
Las Vegas, Nevada, 89109, United States
Hematology-Oncology Associates PC
Albuquerque, New Mexico, 87102, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87102, United States
Hematology Oncology Associates, PC
Medforo, Oregon, 97504, United States
Virginia Physicians, Inc
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2002
First Posted
January 10, 2002
Study Start
October 1, 2001
Primary Completion
November 1, 2002
Study Completion
November 1, 2002
Last Updated
February 1, 2012
Record last verified: 2012-01