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

November 1, 2016 updated by: Hoffmann-La Roche

Randomized, Open Label Study to Assess the Efficacy and Safety of the Intravenous and Oral Ibandronic Acid for Improving the Performance Status of Patients With Malignant Bone Disease Secondary to Solid Tumors and Hematological Malignancies

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Bourgas, Bulgaria, 8000
      • Haskovo, Bulgaria, 6300
      • Pleven, Bulgaria, 5800
      • Plovdiv, Bulgaria, 4004
      • Sofia, Bulgaria, 1757
      • Sofia, Bulgaria, 1784
      • Varna, Bulgaria, 9002
      • Varna, Bulgaria, 9010
      • Vratza, Bulgaria, 3000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibandronate IV Infusion
Participants will receive ibandronate, 6 mg via IV infusion, every 3 to 4 weeks for 4 months.
Drug: 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.
Other Names:
  • Bondronat
Experimental: Ibandronate PO Tablet
Participants will receive ibandronate, 50 mg PO daily, for 4 months.
Drug: 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.
Other Names:
  • Bondronat

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate according to reduction in BPI most acute pain score from Baseline
Time Frame: Month 4
Month 4
Change in KPI
Time Frame: Baseline to Month 4
Baseline to Month 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to onset of decrease in most acute pain score
Time Frame: Up to 4 months
Up to 4 months
Analgesic consumption according to participant diary
Time Frame: Up to 5 months
Up to 5 months
Incidence of adverse events
Time Frame: Up to 5 months
Up to 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 24, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 25, 2015

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML20713

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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