Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions

This study has been completed.

First Received on January 9, 2002. Last Updated on January 30, 2012 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00029224

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Multiple Myeloma Prostate Cancer	Drug: zoledronic acid	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia breast cancer hemophilia

MedlinePlus related topics: Breast Cancer Cancer Multiple Myeloma Prostate Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Pain score assessed by change from baseline [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Designated as safety issue: No ]
Time in infusion chair [ Designated as safety issue: No ]
Safety assessed by adverse events (AEs) [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	October 2001
Study Completion Date:	November 2002
Primary Completion Date:	November 2002 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029224

Locations

United States, California
Stockton Hematology Oncology Medical Group
Stockton, California, United States, 95204
United States, Florida
Osceola Cancer Center
Kissimmee, Florida, United States, 34741
United States, Nevada
Nevada Cancer Center
Las Vegas, Nevada, United States, 89109
United States, New Mexico
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, United States, 87102
Hematology-Oncology Associates PC
Albuquerque, New Mexico, United States, 87102
United States, Oregon
Hematology Oncology Associates, PC
Medforo, Oregon, United States, 97504
United States, Virginia
Virginia Physicians, Inc
Richmond, Virginia, United States, 23294

Sponsors and Collaborators

Novartis

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00029224 History of Changes
Other Study ID Numbers:	CZOL446EUS16
Study First Received:	January 9, 2002
Last Updated:	January 30, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

bone lesions
breast cancer
multiple myeloma

prostate cancer
bone metastases
pain

Additional relevant MeSH terms:

Breast Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders

Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012