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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00081653
First received: April 19, 2004
Last updated: August 7, 2015
Last verified: August 2015
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 November 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 (NCT00081653) and who had complied with the monthly regimen for 75 percent (%) or more.

Reporting Groups
  Description
Ibandronate 100 Milligrams (mg) 100 mg ibandronate oral (PO) monthly and monthly oral placebo (corresponding to the 150 mg tablet)
Ibandronate 150 mg 150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)

Participant Flow:   Overall Study
    Ibandronate 100 Milligrams (mg)   Ibandronate 150 mg
STARTED   358 [1]   361 [1] 
COMPLETED   311 [2]   324 [2] 
NOT COMPLETED   47   37 
Adverse Event                23                17 
Lost to Follow-up                2                4 
Refused Treatment                18                14 
Low bone mineral density                1                0 
Bone loss                2                0 
Participant leaving country                1                0 
Loss of bone mass                0                2 
[1] Patients entering Study 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.
Intent -To - Treat (ITT) population: All participants who were randomized into this study, received at least one dose of the trial medication, and had at least one follow-up efficacy data point (BMD or serum C-terminal peptide cross-links of Collagen Type I [CTX]).

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

Baseline Measures
   Ibandronate 100 mg   Ibandronate 150 mg   Total 
Overall Participants Analyzed 
[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 
BMI (kg/m^2) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 25.87  (4.957)   26.04  (3.976)   25.96  (4.489) 
Race, Customized 
[Units: Participants]
     
Caucasian/White   341   338   679 
Black   0   1   1 
Oriental   0   1   1 
Hispanic   17   20   37 
Other   0   1   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD   [ Time Frame: Baseline and Months 12, 24 and 36 ]

2.  Primary:   Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)   [ Time Frame: Baseline and Months 12, 24 and 36 ]

3.  Secondary:   Absolute Change From Baseline in Mean Total Hip BMD   [ Time Frame: Baseline and 12, 24 and 36 months ]

4.  Secondary:   Relative Percent Change From Baseline in Mean Total Hip BMD   [ Time Frame: Baseline, 12, 24 and 36 months ]

5.  Secondary:   Absolute Change From Baseline of Trough Serum CTX   [ Time Frame: Baseline, 6, 12, 24 and 36 months ]

6.  Secondary:   Relative Percent Change From Baseline of Trough Serum CTX   [ Time Frame: Baseline, 6,12, 24 and 36 months ]


  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 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



Responsible Party: 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: August 7, 2015
Health Authority: United States: Food and Drug Administration