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 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Dept of Oncology, Helsinki University Central Hospital
Helsinki, Helsinki, Finland
NOT_YET_RECRUITINGDept of Oncology, Oulu University Hospital
Oulu, Oulu, Finland
RECRUITINGDept of Oncology, Tampere University Hospital
Tampere, Finland
NOT_YET_RECRUITINGWorst 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
Analgesic consumption during the same period will additionally be assessed
Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28
World Health Organization (WHO) performance status
Safety: serum cystatin C and serum creatinine, and reporting of adverse events
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.