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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00172029 |
The aim of this prospective, randomized, open-label, multicentric clinical study is to assess the effícacy and tolerability of zoledronic acid 4 mg IV infused over 15 minutes every 4 weeks for a total of 6 infusions, in combination with standard or reduced dose radiotherapy in patients with breast cancer and metastatic bone disease associated with pain.
Condition | Intervention | Phase |
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Breast Cancer With Metastatic Bone Disease |
Drug: Zoledronic acid |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study Comparing Full-Dose Radiotherapy Versus Reduced Dose in the Management of Bone Metastasis in Patients With Breast Cancer Receiving Zoledronic Acid |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Other protocol-defined inclusion/exclusion criteria may apply.
Study ID Numbers: | CZOL446ETR01 |
Study First Received: | September 13, 2005 |
Last Updated: | December 19, 2005 |
ClinicalTrials.gov Identifier: | NCT00172029 History of Changes |
Health Authority: | Turkey: Ministry of Health |
Zoledronic acid Radiotherapy Bone pain Breast cancer |
Diphosphonates Zoledronic acid Skin Diseases Musculoskeletal Diseases Neoplasm Metastasis |
Breast Neoplasms Bone Density Conservation Agents Pain Bone Diseases Breast Diseases |
Zoledronic acid Skin Diseases Physiological Effects of Drugs Breast Neoplasms Bone Density Conservation Agents Bone Diseases Pharmacologic Actions Neoplasms |
Neoplastic Processes Neoplasms by Site Pathologic Processes Diphosphonates Musculoskeletal Diseases Neoplasm Metastasis Breast Diseases |