NCT00381368

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: University of Turku · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Ibandronic acid

Timeline

• Start date: 2006-10-01
• First posted: 2006-09-27
• Last updated: 2006-12-04

Locations

3 sites across 1 country: Finland