Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
breast cancer, skeletal metastases, bisphosphonate therapy, Breast cancer with painful skeletal metastases
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Ibandronic acid
Type: Drug
Overall Status
Recruiting
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 skeletal metastases.
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:

- Breast cancer with presence of bone metastases

- Pain score over 4 on the VAS

Exclusion Criteria:

- Patients with pathological fractures or medulla compression or neuropathic pain

- Patients with infection or corticosteroid treatment

- Pregnant or lactating patients
Locations
Dept of Oncology, Helsinki University Central Hospital
Helsinki, Finland
Status: Not yet recruiting
Dept of Oncology, Oulu University Hospital
Oulu, Finland
Status: Recruiting
Dept of Oncology, Tampere University Hospital
Tampere, Finland
Status: Not yet recruiting
Start Date
October 2006
Sponsors
University of Turku
Source
University of Turku
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page