Phase II Open Label Study to Establish the Safety and Efficacy of Intravenous Loading Dose of Ibandronate 6 mg in 3 Consecutive Days in Breast Cancer Patients With Skeletal Metastases
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 patients often need additional treatments that may relieve their
symptoms. Bisphosphonates, such as ibandronic acid, have in pilot studies shown a
significant decrease in pain scores, both after loading dose and after long-term treatment.
In this study the safety and efficacy of an intravenous loading dose of three times 6 mg
ibandronate during three consecutive days in breast cancer patients with painful skeletal
metastases will be studied.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Worst and average pain in movement and rest on the visual analogue scale (VAS) before the first dose, on days 2, 3, 7 and on day 28
Outi Paija, MD, PhD
Dept of Oncology, Turku University Hospital, Finland
Finland: Finnish Medicines Agency