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A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease

This study has been terminated.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00099203
First received: December 10, 2004
Last updated: May 20, 2008
Last verified: May 2008
  Purpose

This 2 arm study will compare the efficacy of intravenous 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 and then every 3-4 weeks) 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.


Condition Intervention Phase
Pain;
Bone Neoplasms;
Neoplasm Metastasis
Drug: ibandronate [Bondronat]
Drug: zoledronic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pain, as measured by Brief Pain Inventory and analgesic use [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Performance score and QoL measures [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Opioid side effects [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Skeletal-related events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: July 2005
Estimated Study Completion Date: January 2007
Arms Assigned Interventions
Experimental: 1 Drug: ibandronate [Bondronat]
6mg iv on days 1-3, and every 3-4 weeks
Active Comparator: 2 Drug: zoledronic acid
4mg iv on day 1 and every 3-4 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 the 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099203

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35205
United States, Arizona
Sedona, Arizona, United States, 86336
United States, Florida
Ocoee, Florida, United States, 34761
United States, Georgia
Macon, Georgia, United States, 31201
United States, Illinois
Galesburg, Illinois, United States, 61401
United States, Indiana
Indianapolis, Indiana, United States, 46227
United States, Missouri
Kansas City, Missouri, United States, 64131
United States, Nevada
Henderson, Nevada, United States, 89052
Reno, Nevada, United States, 89502
United States, New York
Albany, New York, United States, 12208
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Eugene, Oregon, United States, 97401-8122
United States, Tennessee
Nashville, Tennessee, United States, 37209
United States, Texas
Abilene, Texas, United States, 79606-5208
Arlington, Texas, United States, 76014
Beaumont, Texas, United States, 77702-1449
Dallas, Texas, United States, 75230
Dallas, Texas, United States, 75231
Fort Worth, Texas, United States, 76177
Fredericksburg, Texas, United States, 78624
Longview, Texas, United States, 75601
Round Rock, Texas, United States, 78681
United States, Virginia
Norfolk, Virginia, United States, 23502
United States, Washington
Seattle, Washington, United States, 98104
Spokane, Washington, United States, 99218
Vancouver, Washington, United States, 98684
Argentina
Buenos Aires, Argentina, C1408INH
Buenos Aires, Argentina, C1406FWY
Buenos Aires, Argentina, C1280AEB
La Plata, Argentina, 1900
Lanus, Argentina, B1824DLR
Mendoza, Argentina, 5500
Australia
St. Leonards, Australia, 2065
Waratah, Australia, 2298
Belgium
Bruxelles, Belgium, 1000
Turnhout, Belgium, 2300
Wilrijk, Belgium, 2610
Canada, Quebec
Greenfield Park, Quebec, Canada, J4V 2H1
Chile
Santiago, Chile
France
Lyon, France, 69373
Nice, France, 06189
Paris, France, 75248
Germany
Dessau, Germany, 06846
Duisburg, Germany, 47166
Heidelberg, Germany, 69120
Trier, Germany, 54290
Guatemala
Guatemala City, Guatemala
Guatemala City, Guatemala, 01015
Guatemala City, Guatemala, 01010
Hungary
Budapest, Hungary, 1125
Gyor, Hungary, 9002
Italy
Napoli, Italy, 80131
Mexico
Chihuahua, Mexico, 31000
Merida, Mexico, 97500
Mexico City, Mexico, 03100
Panama
Panama City, Panama
Poland
Lodz, Poland, 93-510
Olsztyn, Poland, 10-228
Otwock, Poland, 05-400
Puerto Rico
Ponce, Puerto Rico, 00733-1324
San Juan, Puerto Rico, 00921-3201
Russian Federation
Kazan, Russian Federation, 420029
Moscow, Russian Federation, 117837
Moscow, Russian Federation, 125284
Moscow, Russian Federation, 115478
Moscow, Russian Federation
Obninsk, Russian Federation, 249020
St Petersburg, Russian Federation, 197758
St Petersburg, Russian Federation, 197022
Switzerland
Baden, Switzerland, 5404
United Kingdom
Exeter, United Kingdom, EX2 5DW
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00099203     History of Changes
Other Study ID Numbers: BO18040
Study First Received: December 10, 2004
Last Updated: May 20, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bone Diseases
Bone Neoplasms
Neoplasm Metastasis
Neoplasms
Musculoskeletal Diseases
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Ibandronic acid
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014