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

Tracking Information
First Received Date ^ICMJE	January 9, 2002
Last Updated Date	November 20, 2009
Start Date ^ICMJE	October 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: August 18, 2006)	Pain score assessed by change from baseline
Original Primary Outcome Measures ^ICMJE	Same as current
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	Same as current

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
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Breast Cancer Multiple Myeloma Prostate Cancer
Intervention ^ICMJE	Drug: zoledronic acid
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	500
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00029224
Responsible Party
Study ID Numbers ^ICMJE	CZOL446EUS16
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP