Safety and Efficacy Study of Intravenous Loading Dose of Ibandronate in Breast Cancer Patients - Full Text View

Sponsor:	University of Turku
Collaborator:	Hoffmann-La Roche
Information provided by:	University of Turku
ClinicalTrials.gov Identifier:	NCT00381368

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Ibandronic acid	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

Further study details as provided by University of Turku:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	60
Study Start Date:	October 2006

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381368

Contacts

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

Locations

Finland
Dept of Oncology, Tampere University Hospital	Not yet recruiting
Tampere, Finland, 33521
Principal Investigator: Pirkko Kellokumpu-Lehtinen, PhD, professor
Dept of Oncology, Helsinki University Central Hospital	Not yet recruiting
Helsinki, Finland, 00029
Principal Investigator: Tiina Saarto, MD, PhD
Dept of Oncology, Oulu University Hospital	Recruiting
Oulu, Finland, 90029
Principal Investigator: Arja Jukkola, MD, PhD

Sponsors and Collaborators

University of Turku

Hoffmann-La Roche

Investigators

Principal Investigator:

Outi Paija, MD, PhD

Dept of Oncology, Turku University Hospital, Finland

More Information

No publications provided

Study ID Numbers:	ML20115, EudraCT: 2006-000697-74
Study First Received:	September 25, 2006
Last Updated:	December 1, 2006
ClinicalTrials.gov Identifier:	NCT00381368 History of Changes
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by University of Turku:

breast cancer
skeletal metastases
bisphosphonate therapy
Breast cancer with painful skeletal metastases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Ibandronic acid
Skin Diseases
Physiological Effects of Drugs

Breast Neoplasms
Bone Density Conservation Agents
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010