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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00029224
First received: January 9, 2002
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  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 4

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:

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 May 21, 2013