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A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

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ClinicalTrials.gov Identifier: NCT00377234
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : July 22, 2015
Last Update Posted : August 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Post Menopausal Osteoporosis
Interventions: Drug: Risedronate
Drug: ibandronate [Bonviva/Boniva]

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Of the 488 patients who were screened, 356 patients were enrolled into the study at 44 centers in the USA and randomized to treatment with ibandronate and risedronate. One hundred eighty patients were randomized to Sequence A (Period 1 ibandronate, Period 2 risedronate), and 176 patients to Sequence B (Period 1 risedronate, Period 2 ibandronate).

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
Sequence A Ibandronate followed by risedronate
Sequence B Risedronate followed by ibandronate

Participant Flow:   Overall Study
    Sequence A   Sequence B
STARTED   180   176 
Randomized   180   176 
Did Not Receive Study Treatment   3   2 
Received Treatment   177   174 
Safety Analysis Set: Period 1   177   174 
Safety Analysis Set: Period 2   153   150 
Safety Analysis Set: Ibandronate   177   150 
Safety Analysis Set: Risedronate   153   174 
COMPLETED   146   145 
NOT COMPLETED   34   31 
Adverse Event                14                17 
Withdrawal by Subject                11                9 
Lost to Follow-up                4                2 
Administrative                2                1 
Not assigned                3                2 



  Baseline Characteristics

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.
Safety Analysis Set

Reporting Groups
  Description
Sequence A Ibandronate followed by risedronate
Sequence B Risedronate followed by ibandronate
Total Total of all reporting groups

Baseline Measures
   Sequence A   Sequence B   Total 
Overall Participants Analyzed 
[Units: Participants]
 177   174   351 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.6  (7.0)   64.0  (6.7)   64.3  (6.9) 
Gender 
[Units: Participants]
     
Female   177   174   351 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   177   174   351 


  Outcome Measures

1.  Primary:   Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing   [ Time Frame: at 6 months ]

2.  Secondary:   Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate   [ Time Frame: within 6 months ]

3.  Secondary:   Intensity of Upper Gastrointestinal (GI) Symptoms   [ Time Frame: within 3 months ]

4.  Secondary:   Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)   [ Time Frame: 3 months ]

5.  Secondary:   Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP)   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Hoffmann-LaRoche
phone: 800-821-8590



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377234     History of Changes
Other Study ID Numbers: MA19547
First Submitted: September 15, 2006
First Posted: September 18, 2006
Results First Submitted: June 25, 2015
Results First Posted: July 22, 2015
Last Update Posted: August 1, 2016