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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00029224
Recruitment Status : Completed
First Posted : January 10, 2002
Last Update Posted : February 1, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Tracking Information
First Submitted Date  ICMJE January 9, 2002
First Posted Date  ICMJE January 10, 2002
Last Update Posted Date February 1, 2012
Study Start Date  ICMJE October 2001
Actual Primary Completion Date November 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2006)
Pain score assessed by change from baseline
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00029224 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2006)
  • Quality of life
  • Time in infusion chair
  • Safety assessed by adverse events (AEs)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Multiple Myeloma
  • Prostate Cancer
Intervention  ICMJE Drug: zoledronic acid
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2002
Actual Primary Completion Date November 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00029224
Other Study ID Numbers  ICMJE CZOL446EUS16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP