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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00478270 |
This single arm study will assess the efficacy of loading doses of intravenous Bondronat in reducing pain in patients with breast cancer and metastatic bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Condition | Intervention | Phase |
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Pain; Bone Neoplasms; Neoplasm Metastasis |
Drug: ibandronate [Bondronat] |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Study to Assess the Effect of Intravenous Loading Doses of Bondronat on Metastatic Bone Pain in Patients With Breast Cancer and Skeletal Metastases. |
Estimated Enrollment: | 52 |
Estimated Study Completion Date: | January 2008 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: ibandronate [Bondronat]
6mg iv on days 1-3
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Greece | |
Alexandroupolis, Greece | |
Athens, Greece | |
Haidari, Greece | |
Thessaloniki, Greece | |
Piraeus, Greece | |
Patras, Greece |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML20247 |
Study First Received: | May 23, 2007 |
Last Updated: | March 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00478270 History of Changes |
Health Authority: | Greece: E.O.F. (National drug organization) |
Ibandronic acid Skin Diseases Musculoskeletal Diseases Bone Neoplasms Neoplasm Metastasis |
Breast Neoplasms Bone Density Conservation Agents Pain Bone Diseases Breast Diseases |
Bone Neoplasms Skin Diseases Physiological Effects of Drugs Breast Neoplasms Bone Density Conservation Agents Bone Diseases Pharmacologic Actions Neoplasms |
Neoplastic Processes Neoplasms by Site Pathologic Processes Musculoskeletal Diseases Ibandronic acid Neoplasm Metastasis Breast Diseases |