A Study of Ibandronate (Bondronat) in Participants With Metastatic Bone Disease

NCT ID: NCT02564107

Last Updated: 2016-11-02

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-04-30

Brief Summary

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This study will evaluate the efficacy, safety, and effect on quality of life of oral ibandronate (Bondronat) in participants with breast cancer and metastatic bone disease. The anticipated time on study treatment is 25 weeks, and the target sample size is 50 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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Ibandronate

Female participants with metastatic bone disease secondary to breast cancer will receive ibandronate for a period of 25 weeks.

Group Type EXPERIMENTAL

Ibandronate

Intervention Type DRUG

Participants will receive ibandronate, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks.

Interventions

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Ibandronate

Participants will receive ibandronate, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks.

Intervention Type DRUG

Other Intervention Names

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Bondronat

Eligibility Criteria

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Inclusion Criteria

* Females at least 18 years of age
* Breast cancer
* Bone metastases

Exclusion Criteria

* Use of bisphosphonates within the last 3 months
* Prior use of gallium nitrate or metastron
* Severely impaired renal function
* Hypocalcemia or primary hyperparathyroidism
* Central nervous system (CNS) metastases
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_CHAIR

Hoffmann-La Roche

Locations

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Plovdiv, , Bulgaria

Site Status

Shumen, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Stara Zagora, , Bulgaria

Site Status

Varna, , Bulgaria

Site Status

Veliko Tarnovo, , Bulgaria

Site Status

Countries

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Bulgaria

Other Identifiers

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ML18044

Identifier Type: -

Identifier Source: org_study_id