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

NCT ID: NCT00381368

Last Updated: 2006-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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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

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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

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Breast Cancer

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ibandronic acid

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

University of Turku

OTHER

Sponsor Role lead

Principal Investigators

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Outi Paija, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept of Oncology, Turku University Hospital, Finland

Locations

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Dept of Oncology, Helsinki University Central Hospital

Helsinki, Helsinki, Finland

Site Status NOT_YET_RECRUITING

Dept of Oncology, Oulu University Hospital

Oulu, Oulu, Finland

Site Status RECRUITING

Dept of Oncology, Tampere University Hospital

Tampere, , Finland

Site Status NOT_YET_RECRUITING

Countries

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Finland

Central Contacts

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Outi Paija, MD, PhD

Role: CONTACT

Phone: +358-2-3130000

Email: [email protected]

Tiina Saarto, MD, PhD

Role: CONTACT

Email: [email protected]

Other Identifiers

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EudraCT: 2006-000697-74

Identifier Type: -

Identifier Source: secondary_id

ML20115

Identifier Type: -

Identifier Source: org_study_id