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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
No text entered.

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
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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.
No text entered.

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).
Total Total of all reporting groups

Baseline Measures
    Ibandronate 3 mg Injection     Ibandronate 3 mg Infusion     Alendronate 70 mg Oral     Total  
Number of Participants  
[units: participants]
  263     263     267     793  
Age  
[units: years]
Mean ± Standard Deviation
  71.7  ± 6.77     71.5  ± 5.89     71.7  ± 6.3     71.6  ± 6.32  
Gender  
[units: participants]
       
Female     263     263     267     793  
Male     0     0     0     0  



  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
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Time Frame AEs are considered to have occurred ‘On treatment’, defined as first dose and up 106 days after last dose if patient’s actual treatment is ibandronate, or up to 22 days after last dose if patient’s actual treatment is the alendronate.
Additional Description No text entered.

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).

Serious Adverse Events
    Ibandronate 3 mg Injection     Ibandronate 3 mg Infusion     Alendronate 70 mg Oral  
Total, serious adverse events        
# participants affected / at risk     19/263 (7.22%)     15/263 (5.70%)     13/267 (4.87%)  
Blood and lymphatic system disorders        
Autoimmune Thrombocytopenia * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Cardiac disorders        
Atrial Fibrillation * 1      
# participants affected / at risk     1/263 (0.38%)     1/263 (0.38%)     0/267 (0.00%)  
Cardiac Failure Congestive * 1      
# participants affected / at risk     2/263 (0.76%)     0/263 (0.00%)     0/267 (0.00%)  
Acute Coronary Syndrome * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Angina Pectoris * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Conduction Disorder * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Myocardial Infarction * 1      
# participants affected / at risk     1/263 (0.38%)     0/263 (0.00%)     0/267 (0.00%)  
Supraventricular Tachycardia * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Gastrointestinal disorders        
Abdominal Pain * 1      
# participants affected / at risk     1/263 (0.38%)     1/263 (0.38%)     0/267 (0.00%)  
Haematochezia * 1      
# participants affected / at risk     1/263 (0.38%)     0/263 (0.00%)     0/267 (0.00%)  
Nausea * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Pancreatitis Acute * 1      
# participants affected / at risk     1/263 (0.38%)     0/263 (0.00%)     0/267 (0.00%)  
Peptic Ulcer Perforation * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Small Intestinal Obstruction * 1      
# participants affected / at risk     1/263 (0.38%)     0/263 (0.00%)     0/267 (0.00%)  
Vomiting * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Hepatobiliary disorders        
Cholecystitis * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     1/267 (0.37%)  
Cholecystitis Acute * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Cholelithiasis * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Infections and infestations        
Pneumonia * 1      
# participants affected / at risk     1/263 (0.38%)     1/263 (0.38%)     1/267 (0.37%)  
Abdominal Abscess * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Gastroenteritis * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Herpes Zoster * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Pyelonephritis * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Urinary Tract Infection * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Injury, poisoning and procedural complications        
Femur Fracture * 1      
# participants affected / at risk     3/263 (1.14%)     1/263 (0.38%)     4/267 (1.50%)  
Femoral Neck Fracture * 1      
# participants affected / at risk     3/263 (1.14%)     1/263 (0.38%)     1/267 (0.37%)  
Ankle Fracture * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Fall * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Head Injury * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Multiple Drug Overdose Accidental * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Multiple Fractures * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Traumatic Brain Injury * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Vascular Pseudoaneurysm * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Metabolism and nutrition disorders        
Electrolyte Imbalance * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Hyponatraemia * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Musculoskeletal and connective tissue disorders        
Osteoarthritis * 1      
# participants affected / at risk     2/263 (0.76%)     0/263 (0.00%)     2/267 (0.75%)  
Back Pain * 1      
# participants affected / at risk     1/263 (0.38%)     0/263 (0.00%)     0/267 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Breast Cancer * 1      
# participants affected / at risk     2/263 (0.76%)     0/263 (0.00%)     0/267 (0.00%)  
Breast Cancer Stage II * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Colon Cancer * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Lymphoma * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Nervous system disorders        
Dizziness * 1      
# participants affected / at risk     1/263 (0.38%)     0/263 (0.00%)     0/267 (0.00%)  
Hemiparesis * 1      
# participants affected / at risk     1/263 (0.38%)     0/263 (0.00%)     0/267 (0.00%)  
Ischemic Stroke * 1      
# participants affected / at risk     1/263 (0.38%)     0/263 (0.00%)     0/267 (0.00%)  
Ruptured Cerebral Aneurysm * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Senile Dementia * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Subarachnoid Haemorrhage * 1      
# participants affected / at risk     1/263 (0.38%)     0/263 (0.00%)     0/267 (0.00%)  
Reproductive system and breast disorders        
Breast Mass * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
Chronic Obstructive Pulmonary Disease * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     1/267 (0.37%)  
Asthma * 1      
# participants affected / at risk     0/263 (0.00%)     0/263 (0.00%)     1/267 (0.37%)  
Haemoptysis * 1      
# participants affected / at risk     1/263 (0.38%)     0/263 (0.00%)     0/267 (0.00%)  
Pulmonary Embolism * 1      
# participants affected / at risk     1/263 (0.38%)     0/263 (0.00%)     0/267 (0.00%)  
Vascular disorders        
Hypertensive Crisis * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
Temporal Arteritis * 1      
# participants affected / at risk     0/263 (0.00%)     1/263 (0.38%)     0/267 (0.00%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (12.0)




  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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