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A Study of Once Monthly Bonviva (Ibandronate) in Prevention of Glucocorticoid-Induced Osteoporosis.

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545051
First received: October 16, 2007
Last updated: April 5, 2016
Last verified: April 2016
Results First Received: April 5, 2016  
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: Postmenopausal Osteoporosis
Interventions: Drug: Placebo
Drug: ibandronate

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ibandronate Participants received 150 milligram (mg) ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 International Units (IU) Vitamin D per day.
Placebo Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.

Participant Flow:   Overall Study
    Ibandronate     Placebo  
STARTED     68     72  
COMPLETED     59     65  
NOT COMPLETED     9     7  
Adverse Event                 7                 3  
Death                 1                 0  
Violation of inclusion/exclusion                 0                 2  
Protocol Violation                 1                 0  
Withdrawal by Subject                 0                 1  
Administrative reasons                 0                 1  



  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.
The intent-to-treat (ITT) population included all participants randomized and who had at least one follow up efficacy data time point available.

Reporting Groups
  Description
Ibandronate Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Placebo Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
Total Total of all reporting groups

Baseline Measures
    Ibandronate     Placebo     Total  
Number of Participants  
[units: participants]
  68     72     140  
Age  
[units: years]
Mean (Standard Deviation)
  64.4  (7.90)     63.2  (6.83)     63.79  (7.39)  
Gender  
[units: participants]
     
Female     68     72     140  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12   [ Time Frame: Baseline and Month 12 ]

2.  Secondary:   Percent Change From Baseline in Mean Lumbar Spine BMD at Month 6   [ Time Frame: Baseline and Month 6 ]

3.  Secondary:   Percent Change From Baseline in Mean Total Hip BMD at Month 6 and Month 12   [ Time Frame: Baseline and Months 6 and 12 ]

4.  Secondary:   Percent Change From Baseline in Bone Turnover Markers at Month 1, Month 6 and Month 12   [ Time Frame: Baseline and Months 1, 6 and 12 ]

5.  Secondary:   Percentage of Participants Withdrawn Due to Worsening in BMD at 6 Months and/or Worsening in BMD at Least 7 Percent (%) at Any Site at 6 Months   [ Time Frame: Month 6 ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmannb-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545051     History of Changes
Other Study ID Numbers: ML20088
Study First Received: October 16, 2007
Results First Received: April 5, 2016
Last Updated: April 5, 2016
Health Authority: Finland: Ministry of Social Affairs and Health/ETENE