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
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Multiple Myeloma, Prostate Cancer
Both
Breast Cancer, Multiple Myeloma, Prostate Cancer
Trial Information
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
Inclusion Criteria
Inclusion Criteria
- 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
- Corrected serum calcium equal to or greater than 8mg/dl Exclusion Criteria
- clinically symptomatic brain metastases
- hypersensitivity to Zometa or other bisphosphonates
- pregnant or lactating
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pain score assessed by change from baseline
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
CZOL446EUS16
NCT ID:
NCT00029224
Start Date:
October 2001
Completion Date:
November 2002
Related Keywords:
- Breast Cancer
- Multiple Myeloma
- Prostate Cancer
- bone lesions
- breast cancer
- multiple myeloma
- prostate cancer
- bone metastases
- pain
- Breast Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Prostatic Neoplasms
Name | Location |
|---|---|
| Nevada Cancer Center | Las Vegas, Nevada 89109 |
| Stockton Hematology Oncology Medical Group | Stockton, California 95204 |
| Osceola Cancer Center | Kissimmee, Florida 34741 |
| New Mexico Oncology Hematology Consultants | Albuquerque, New Mexico 87102 |
| Hematology-Oncology Associates PC | Albuquerque, New Mexico 87102 |
| Hematology Oncology Associates, PC | Medforo, Oregon 97504 |
| Virginia Physicians, Inc | Richmond, Virginia 23294 |
