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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

December 10, 2004
May 20, 2008
July 2005
Not Provided
Pain, as measured by Brief Pain Inventory and analgesic use [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00099203 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
A Study to Assess the Efficacy of Intravenous Bondronat (Ibandronate) in Patients With Malignant and Painful Bone Disease
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Pain;
  • Bone Neoplasms;
  • Neoplasm Metastasis
  • Drug: ibandronate [Bondronat]
    6mg iv on days 1-3, and every 3-4 weeks
  • Drug: zoledronic acid
    4mg iv on day 1 and every 3-4 weeks
  • Experimental: 1
    Intervention: Drug: ibandronate [Bondronat]
  • Active Comparator: 2
    Intervention: Drug: zoledronic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
450
January 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Belgium,   Canada,   Chile,   France,   Germany,   Guatemala,   Hungary,   Italy,   Mexico,   Panama,   Poland,   Puerto Rico,   Russian Federation,   Switzerland,   United Kingdom
 
NCT00099203
BO18040
Not Provided
Clinical Trials, Study Director, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP