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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

Tracking Information
First Submitted Date  ICMJE December 10, 2004
First Posted Date  ICMJE December 10, 2004
Last Update Posted Date August 16, 2017
Study Start Date  ICMJE August 2005
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
Pain, as measured by Brief Pain Inventory and analgesic use [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
  • Performance score and QoL measures [ Time Frame: Week 24 ]
  • AEs and laboratory parameters [ Time Frame: Throughout study ]
  • Opioid side effects [ Time Frame: Throughout study ]
  • Skeletal-related events [ Time Frame: Throughout study ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy of Intravenous/Oral Bondronat (Ibandronate) in Patients With Metastatic Bone Disease Experiencing Moderate to Severe Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Bone Neoplasm
  • Neoplasm Metastasis
Intervention  ICMJE
  • Drug: ibandronate [Bondronat]
    6mg iv on days 1-3, and 50mg po from day 22 to week 24
  • Drug: zoledronic acid
    4mg iv on day 1, and every 3-4 weeks
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: ibandronate [Bondronat]
  • Active Comparator: 2
    Intervention: Drug: zoledronic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 23, 2016)
96
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Chile,   Germany,   Greece,   Guatemala,   Hungary,   Italy,   Mexico,   Panama,   Poland,   Puerto Rico,   Russian Federation,   Switzerland,   United Kingdom,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00099177
Other Study ID Numbers  ICMJE BO18039
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinical Trials, Study Director, Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date August 2017

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