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MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00048061
First received: October 24, 2002
Last updated: April 22, 2016
Last verified: April 2016
Results First Received: February 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Post Menopausal Osteoporosis
Interventions: Drug: Ibandronate [Bonviva/Boniva]
Dietary Supplement: Calcium
Dietary Supplement: Vitamin D

  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
The study was conducted from 26 April 2002 to 08 Dec 2004 across 65 centers in the world.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 1609 participants were randomized, of which 1602 received the study drug.

Reporting Groups
  Description
Ibandronate 2.5 mg Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day.
Ibandronate 50/50 mg Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Ibandronate 100 mg Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Ibandronate 150 mg Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.

Participant Flow:   Overall Study
    Ibandronate 2.5 mg     Ibandronate 50/50 mg     Ibandronate 100 mg     Ibandronate 150 mg  
STARTED     400     401     400     401  
COMPLETED     325     328     316     322  
NOT COMPLETED     75     73     84     79  
Adverse Event                 41                 32                 44                 37  
Lost to Follow-up                 3                 2                 4                 5  
Withdrawal by Subject                 20                 29                 29                 32  
Did not follow-up                 5                 5                 4                 5  
Early improvement                 6                 5                 3                 0  



  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 safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.

Reporting Groups
  Description
Ibandronate 2.5 mg Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Ibandronate 50/50 mg Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Ibandronate 100 mg Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Ibandronate 150 mg Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
Total Total of all reporting groups

Baseline Measures
    Ibandronate 2.5 mg     Ibandronate 50/50 mg     Ibandronate 100 mg     Ibandronate 150 mg     Total  
Number of Participants  
[units: participants]
  395     396     396     396     1583  
Age  
[units: years]
Mean (Standard Deviation)
  65.8  (6.61)     66.0  (6.71)     66.2  (6.38)     66.2  (6.64)     66.0  (6.58)  
Gender  
[units: participants]
         
Female     395     396     396     396     1583  
Male     0     0     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 – L4) Bone Mineral Density   [ Time Frame: From Baseline (Month 0) to Month 12 ]

2.  Secondary:   Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD   [ Time Frame: From Baseline (Month 0) to Month 24 ]

3.  Secondary:   Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD   [ Time Frame: From Baseline (Month 0) to Months 12 and 24 ]

4.  Secondary:   Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD   [ Time Frame: From Baseline (Month 0) to Months 12 and 24 ]

5.  Secondary:   Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.   [ Time Frame: From Baseline (Month 0) to Months 12 and 24 ]

6.  Secondary:   Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24   [ Time Frame: Months 12 and 24 ]

7.  Secondary:   Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24   [ Time Frame: Months 12 and 24 ]

8.  Secondary:   Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24   [ Time Frame: Months 12 and 24 ]

9.  Secondary:   Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24   [ Time Frame: Months 12 and 24 ]

10.  Secondary:   Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24   [ Time Frame: Months 12 and 24 ]

11.  Secondary:   Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24   [ Time Frame: Months 12 and 24 ]

12.  Secondary:   Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24   [ Time Frame: Months 12 and 24 ]

13.  Secondary:   Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24   [ Time Frame: From Baseline (Month 0) to Months 3, 6, 12, 24 ]

14.  Secondary:   Absolute Change In Baseline in Serum CTX to Months 12 and 24   [ Time Frame: From Baseline (Month 0) to Months 12 and 24 ]

15.  Secondary:   Number of Participants With Any Adverse Events and Serious Adverse Event   [ Time Frame: Up to Month 24 ]

16.  Secondary:   Number Of Participants With Marked Laboratory Abnormalities   [ Time Frame: Up to Month 24 ]


  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: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
phone: +41 616878333
e-mail: global.trial_information@roche.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00048061     History of Changes
Other Study ID Numbers: BM16549
Study First Received: October 24, 2002
Results First Received: February 5, 2016
Last Updated: April 22, 2016
Health Authority: United States: Food and Drug Administration