A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain

August 14, 2017 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study of the Effect of Bondronat Compared With Zoledronic Acid on Pain in Patients With Malignant Bone Disease Experiencing Moderate to Severe Pain

This 2 arm study will compare the efficacy of a regimen of intravenous (iv) and oral Bondronat with that of zoledronic acid in patients with malignant bone disease experiencing moderate to severe pain. Patients will be randomized to receive either Bondronat (6mg iv on days 1, 2 and 3 followed by Bondronat 5Omg po daily from day 22 to week 24) or zoledronic acid (4mg iv on day 1, and then every 3-4 weeks). The anticipated time of study treatment is 6-12 months, and the target sample size is 100-500 individuals.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

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

  • Argentina
      • Bahia Blanca, Argentina, B8001HXM
      • Buenos Aires, Argentina, 1426
      • Buenos Aires, Argentina, C1426BOR
      • Rosario, Argentina, 2000
      • Santa Fe, Argentina, 03000
  • Australia
      • Adelaide, Australia, 5011
      • Brisbane, Australia, 4101
  • Chile
      • Santiago, Chile
      • Vina Del Mar, Chile
  • Germany
      • Hamburg, Germany, 22143
  • Greece
      • Kalyftaki Kifissia, Greece
      • Thessaloniki, Greece, 57010
  • Guatemala
      • Guatemala City, Guatemala
  • Hungary
      • Budapest, Hungary, 1122
      • Budapest, Hungary, 1529
      • Deszk, Hungary, 6772
      • Szeged, Hungary, 6720
  • Italy
      • Rozzano, Italy, 20089
      • Torino, Italy, 10126
  • Mexico
      • La Paz, Mexico, 23040
      • Mexicali, Mexico, 21100
      • Mexico City, Mexico, 14050
      • Monterrey, Mexico, 64320
  • Panama
      • Panama City, Panama, 83-0669
  • Poland
      • Poznan, Poland, 60-569
      • Poznan, Poland, 61-878
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
  • Russian Federation
      • Kazan, Russian Federation, 420029
      • Moscow, Russian Federation
      • Moscow, Russian Federation, 125284
      • Moscow, Russian Federation, 115478
      • Moscow, Russian Federation, 117837
      • Obninsk, Russian Federation, 249020
      • St Petersburg, Russian Federation, 197022
      • St Petersburg, Russian Federation, 197758
  • Switzerland
      • St Gallen, Switzerland, 9007
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
      • Sutton, United Kingdom, SM2 5PT
  • United States
    • Florida
      • Miami, Florida, United States, 33136
    • Georgia
      • Macon, Georgia, United States, 31201
    • Texas
      • Houston, Texas, United States, 77030

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:

  • patients with malignant bone disease;
  • patients with moderate to severe pain.

Exclusion Criteria:

  • patients who have received a bisphosphonate within 3 weeks from the signing of informed consent;
  • patients receiving concurrent investigational therapy, or who have received investigational therapy within 30 days of the first scheduled day of dosing;
  • untreated esophagitis or gastric ulcers;
  • recent or pre-scheduled radiotherapy to bone;
  • patients who are pregnant or breast-feeding.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: ibandronate [Bondronat]
6mg iv on days 1-3, and 50mg po from day 22 to week 24
Active Comparator: 2
Drug: zoledronic acid
4mg iv on day 1, and every 3-4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain, as measured by Brief Pain Inventory and analgesic use
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
AEs and laboratory parameters
Time Frame: Throughout study
Throughout study
Performance score and QoL measures
Time Frame: Week 24
Week 24
Opioid side effects
Time Frame: Throughout study
Throughout study
Skeletal-related events
Time Frame: Throughout study
Throughout study

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

August 1, 2005

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

December 10, 2004

First Submitted That Met QC Criteria

December 9, 2004

First Posted (Estimate)

December 10, 2004

Study Record Updates

Last Update Posted (Actual)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO18039

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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