Status:
UNKNOWN
Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients
Lead Sponsor:
University of Turku
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The purpose of the study is to determine the efficacy and safety of a three time repeated loading dose of intravenous ibandronate (ibandronic acid), 6 mg, in breast cancer patients with painful skelet...
Detailed Description
Painful skeletal metastases are a common site of advanced disease. For instance, in breast cancer, and despite cancer treatments (radiotherapy, cytotoxic treatment and adequate treatment of pain), the...
Eligibility Criteria
Inclusion
- Breast cancer with presence of bone metastases
- Pain score over 4 on the VAS
Exclusion
- Patients with pathological fractures or medulla compression or neuropathic pain
- Patients with infection or corticosteroid treatment
- Pregnant or lactating patients
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00381368
Start Date
October 1 2006
Last Update
December 4 2006
Active Locations (3)
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1
Dept of Oncology, Helsinki University Central Hospital
Helsinki, Helsinki, Finland, 00029
2
Dept of Oncology, Oulu University Hospital
Oulu, Oulu, Finland, 90029
3
Dept of Oncology, Tampere University Hospital
Tampere, Finland, 33521