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

NCT ID: NCT02561039

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

PHASE3

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-03-31

Brief Summary

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This study will assess the efficacy and safety of ibandronate (Bondronat), administered intravenously (IV) or orally (PO), in participants with malignant bone disease and moderate to severe pain. Participants will be randomized to receive ibandronate either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily. Pain response and Karnofsky Performance Index (KPI) will be measured at intervals throughout the study. The anticipated time on study treatment is 4 months and the target sample size is 150 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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ibandronate IV Infusion

Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months.

Group Type EXPERIMENTAL

Ibandronate

Intervention Type DRUG

Participants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months.

Ibandronate PO Tablet

Participants will receive ibandronate, 50 mg PO daily, for 4 months.

Group Type EXPERIMENTAL

Ibandronate

Intervention Type DRUG

Participants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months.

Interventions

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Ibandronate

Participants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months.

Intervention Type DRUG

Other Intervention Names

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Bondronat

Eligibility Criteria

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Inclusion Criteria

* Adults at least 18 years of age
* Malignant bone disease due to multiple myeloma or cancer of the lung, prostate, gastrointestinal (GI) tract, ovary, or bladder
* Bone pain defined as a Brief Pain Inventory (BPI) most acute pain score greater than or equal to 4
* Radiologically confirmed bone disease disease

Exclusion Criteria

* Previous treatment with ibandronate (Bondronat) within previous 2 months
* Severely impaired renal function
* Known brain metastases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

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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Burgas, , Bulgaria

Site Status

Haskovo, , Bulgaria

Site Status

Pleven, , Bulgaria

Site Status

Plovdiv, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Sofia, , Bulgaria

Site Status

Varna, , Bulgaria

Site Status

Varna, , Bulgaria

Site Status

Vratsa, , Bulgaria

Site Status

Countries

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Bulgaria

Other Identifiers

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ML20713

Identifier Type: -

Identifier Source: org_study_id