A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00081653
First received: April 19, 2004
Last updated: June 2, 2009
Last verified: June 2009
Results First Received: December 22, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Post-Menopausal Osteoporosis
Intervention: Drug: ibandronate [Bonviva/Boniva]

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from 31 centers over the period of 18 May 2004 to 28 Nov 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible for the study were patients having completed study BM16549 and who had complied with the monthly regimen for 75% or more.

Reporting Groups
  Description
Group A 100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
Group B 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)

Participant Flow:   Overall Study
    Group A     Group B  
STARTED     358 [1]   361 [1]
COMPLETED     311 [2]   324 [2]
NOT COMPLETED     47     37  
Withdrawn from treatment                 47                 37  
[1] Patients entering MA17903 from Study BM16549
[2] Completed 3 years of treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group A 100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
Group B 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
Total Total of all reporting groups

Baseline Measures
    Group A     Group B     Total  
Number of Participants  
[units: participants]
  358     361     719  
Age  
[units: years]
Mean ± Standard Deviation
  67.8  ± 6.55     67.7  ± 6.8     67.7  ± 6.7  
Gender  
[units: participants]
     
Female     358     361     719  
Male     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian/White     341     338     679  
Black     0     1     1  
Oriental     0     1     1  
Hispanic     17     20     37  
Other     0     1     1  
BMI (kg/m**2)  
[units: kg/m**2]
Mean ± Standard Deviation
  25.87  ± 4.957     26.04  ± 3.976     25.96  ± 4.489  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Relative (%) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD   [ Time Frame: Assessed at Baseline +12, 24, and 36 months ]

2.  Primary:   Absolute (g/cm2) Change From MA17903 Baseline in Mean Lumbar Spine (L2 - L4) BMD   [ Time Frame: Assessed at baseline +12, 24 and 36 months ]

3.  Secondary:   Relative (%) and Absolute (g/cm2) Change From MA17903 Baseline in Mean Total Hip BMD   [ Time Frame: 12, 24 and 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Relative (%) and Absolute (ng/mL) Change From MA17903 Baseline of Median Trough Serum CTX [Type I Collagen]   [ Time Frame: 12, 24 and 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Relative (%) and Absolute (ng/mL) Change From MA17903 Baseline of Median Post Dose Suppression of Serum CTX [Type I Collagen]   [ Time Frame: 6 months of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no overall limitations and caveats.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Trials Study Director
Organization: Hoffmann-La Roche
phone: +1 973 235 5000


No publications provided


Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00081653     History of Changes
Other Study ID Numbers: MA17903
Study First Received: April 19, 2004
Results First Received: December 22, 2008
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration