A Study of Loading Doses of Intravenous Bondronat (Ibandronate) in Patients With Breast Cancer and Malignant Bone Disease.

NCT ID: NCT00502736

Last Updated: 2014-01-22

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-03-31

Brief Summary

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This single arm study will assess the efficacy and safety of loading doses of intravenous Bondronat in patients with breast cancer and malignant bone disease experiencing moderate to severe bone pain. Patients will receive an intravenous infusion of 6mg Bondronat on days 1, 2 and 3. The anticipated time on study treatment is 3 months, and the target sample size is \<100 individuals.

Detailed Description

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Conditions

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Pain; Bone Neoplasms; Neoplasm Metastasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

ibandronate [Bondronat]

Intervention Type DRUG

6mg iv on days 1-3

Interventions

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ibandronate [Bondronat]

6mg iv on days 1-3

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* female patients, \>=18 years of age;
* breast cancer;
* bone metastases;
* moderate to severe pain;
* adequate renal function.

Exclusion Criteria

* bisphosphonate treatment within 3 weeks of study enrollment.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Ankara, , Turkey (Türkiye)

Site Status

Ankara, , Turkey (Türkiye)

Site Status

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul, , Turkey (Türkiye)

Site Status

Izmir, , Turkey (Türkiye)

Site Status

Shhiye, Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ML20684

Identifier Type: -

Identifier Source: org_study_id

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