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

Phase 2

• Conditions: Breast Cancer

• Registration Number: NCT00381368
• Lead Sponsor: University of Turku

Brief 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.

Study Timeline

• Study First Submitted: 2006-09-25
• Study First Submitted QC: 2006-09-25
• Study First Posted: 2006-09-27
• Study Start: 2006-10
• Status Verified: 2006-11
• Last Update Submitted: 2006-12-01
• Last Update Posted: 2006-12-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
Analgesic consumption during the same period will additionally be assessed

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Dept of Oncology, Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland

Dept of Oncology, Tampere University Hospital; 🇫🇮 Tampere, Finland

Dept of Oncology, Oulu University Hospital; 🇫🇮 Oulu, Finland