A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00503113
First received: July 17, 2007
Last updated: May 17, 2011
Last verified: May 2011
Results First Received: March 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Post-Menopausal Osteoporosis
Interventions: Drug: ibandronate [Bonviva/Boniva]
Drug: Alendronate

  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
Total 801 participants randomized. Of the randomized patients, 263 who received at least one dose of ibandronate as an injection, 263 who received at least one dose of ibandronate as an infusion and 267 patients who received at least one dose of alendronate had at least one post-baseline assessment and were included in the safety analysis.

Reporting Groups
  Description
Ibandronate 3 mg Injection Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
Ibandronate 3 mg Infusion Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
Alendronate 70 mg Oral Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).

Participant Flow:   Overall Study
    Ibandronate 3 mg Injection     Ibandronate 3 mg Infusion     Alendronate 70 mg Oral  
STARTED     268     264     269  
Intent to Treat Population (ITT)     262     261     268  
Per Protocol Population (PP)     246     243     241  
Safety Population     263     263     267  
COMPLETED     235     236     241  
NOT COMPLETED     33     28     28  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)   [ Time Frame: Baseline and 9 months ]

2.  Secondary:   Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)   [ Time Frame: Baseline and 9 months ]

3.  Secondary:   Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)   [ Time Frame: Baseline and 9 months ]

4.  Secondary:   Relative Change From Baseline in Actual GFR (Using CG Formula)   [ Time Frame: Baseline and 9 months ]

5.  Secondary:   Absolute Change From Baseline in Mean Serum Creatinine.   [ Time Frame: Baseline and 9 months ]

6.  Secondary:   Relative Change From Baseline in Mean Serum Creatinine.   [ Time Frame: Baseline and 9 months ]

7.  Secondary:   Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.   [ Time Frame: Baseline and 9 months ]

8.  Secondary:   Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.   [ Time Frame: Baseline and 9 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