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| 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 |
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 |
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| 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 |
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| Intervention ICMJE | Drug: zoledronic acid |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 500 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
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| 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 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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