A Study to Assess the Short Term Efficacy of Intravenous Ibandronate (Bondronat) in Participants With Metastatic Bone Pain Due to Breast Cancer

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

PHASE4

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-12-31

Brief Summary

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This study will assess the short term efficacy of ibandronate (6 mg intravenous \[IV\]) in participants with breast cancer and malignant bone disease, with moderate to severe pain. All participants will receive an IV infusion of ibandronate on Days 1, 2, and 3, and pain response will be measured on Days 1-7. The anticipated time on study treatment is 3 days, and the target sample size is 182 individuals.

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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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Ibandronate

Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.

Group Type EXPERIMENTAL

Ibandronate

Intervention Type DRUG

Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.

Interventions

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Ibandronate

Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.

Intervention Type DRUG

Other Intervention Names

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Bondronat

Eligibility Criteria

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Inclusion Criteria

* Female participants greater than or equal to (\>=) 18 years of age
* Breast cancer with bone metastases
* Pain score of \>=4 on Worst Pain scale of Brief Pain Inventory (BPI)
* Stable analgesic regimen.

Exclusion Criteria

* Participants who have received a bisphosphonate within 3 weeks of start of trial
* Radiotherapy to bone within 4 weeks of enrolment
* Hypersensitivity to ibandronate
* Central nervous system (CNS) or meningeal metastases

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No