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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2006 by University of Turku.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Hoffmann-La Roche

Information provided by:

University of Turku

ClinicalTrials.gov Identifier:

NCT00381368

First received: September 25, 2006

Last updated: December 1, 2006

Last verified: November 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 25, 2006

Last Updated Date

December 1, 2006

Start Date ^ICMJE

October 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Worst and average pain in movement and rest on the VAS before the first dose, on days 2,3, 7 and on day 28.
Analgesic consumption during the same period will additionally be assessed.

Change History

Complete list of historical versions of study NCT00381368 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Bone markers: serum 1CTP, serum P1NP, serum NTX on day 1 before dosing, and on days 7 and 28.
WHO performance status
Safety: serum cystatin C and serum creatinine, and reporting of adverse events

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: Ibandronic acid

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Outi Paija, MD, PhD	+358-2-3130000 ext 52863	outi.paija@tyks.fi
Contact: Tiina Saarto, MD, PhD		tiina.saarto@hus.fi

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT00381368

Other Study ID Numbers ^ICMJE

ML20115, EudraCT: 2006-000697-74

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Turku

Collaborators ^ICMJE

Hoffmann-La Roche

Investigators ^ICMJE

Principal Investigator:

Outi Paija, MD, PhD

Dept of Oncology, Turku University Hospital, Finland

Information Provided By

University of Turku

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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