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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00099177
Recruitment Status : Terminated
First Posted : December 10, 2004
Last Update Posted : August 16, 2017
Sponsor:
Information provided by:
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Bone Neoplasm Neoplasm Metastasis Drug: ibandronate [Bondronat] Drug: zoledronic acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Diseases

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




Primary Outcome Measures :
  1. Pain, as measured by Brief Pain Inventory and analgesic use [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Performance score and QoL measures [ Time Frame: Week 24 ]
  2. AEs and laboratory parameters [ Time Frame: Throughout study ]
  3. Opioid side effects [ Time Frame: Throughout study ]
  4. Skeletal-related events [ Time Frame: Throughout study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00099177


Locations
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United States, Florida
Miami, Florida, United States, 33136
United States, Georgia
Macon, Georgia, United States, 31201
United States, Texas
Houston, Texas, United States, 77030
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, 115478
Moscow, Russian Federation, 117837
Moscow, Russian Federation, 125284
Moscow, Russian Federation
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00099177    
Other Study ID Numbers: BO18039
First Posted: December 10, 2004    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Neoplasm Metastasis
Bone Neoplasms
Bone Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes
Musculoskeletal Diseases
Neoplasms by Site
Zoledronic Acid
Ibandronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs