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

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

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Novartis:

Primary Outcome Measures:

Pain score assessed by change from baseline

Secondary Outcome Measures:

Quality of life
Time in infusion chair
Safety assessed by adverse events (AEs)

Estimated Enrollment:	500
Study Start Date:	October 2001

Eligibility

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

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
No clinically symptomatic brain metastases
No known hypersensitivity to Zometa or other bisphosphonates
Not 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

Information about zoledronic acid [Zometa] This link exits the ClinicalTrials.gov site

Study ID Numbers:	CZOL446EUS16
First Received:	January 9, 2002
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00029224
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

bone lesions

breast cancer

multiple myeloma

prostate cancer

bone metastases

pain

Study placed in the following topic categories:

Genital Neoplasms, Male

Prostatic Diseases

Blood Protein Disorders

Quality of Life

Paraproteinemias

Pain

Urogenital Neoplasms

Hemostatic Disorders

Hemorrhagic Disorders

Multiple myeloma

Neoplasm Metastasis

Breast Diseases

Immunoproliferative Disorders

Zoledronic acid

Skin Diseases

Hematologic Diseases

Blood Coagulation Disorders

Vascular Diseases

Breast Neoplasms

Genital Diseases, Male

Multiple Myeloma

Diphosphonates

Lymphoproliferative Disorders

Prostatic Neoplasms

Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Neoplasms by Site

Immune System Diseases

Physiological Effects of Drugs

Bone Density Conservation Agents

Cardiovascular Diseases

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00029224