Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients

University of Turku

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Ibandronic acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00381368

ML20115

EudraCT: 2006-000697-74

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)