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

Study Overview
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Brief Summary
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This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Official Title
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A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

Conditions
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Post-Menopausal Osteoporosis

Intervention / Treatment
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* Drug: ibandronate [Bonviva/Boniva]
* Drug: ibandronate [Bonviva/Boniva]
* Drug: Alendronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female patients, >=60 years of age; >=5 years postmenopausal; confirmed osteoporosis, at increased risk for renal disease. Exclusion Criteria: inability to stand or sit upright for 30 minutes; hypersensitivity to bisphosphonates; malignant disease (other than successfully resected basal cell cancer) within previous 10 years, or breast cancer diagnosed within previous 20 years; previous administration of an i.v. bisphosphonate; oral bisphosphonate treatment other than study medication within 30 days prior to the baseline dosing visit and during the study; history of major upper gastrointestinal disease.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 3mg intravenous (iv) injection every 3 months<br>|
| Experimental: 2<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 3mg intravenous (iv) infusion every 3 months<br>|
| Active Comparator: 3<br> | Drug: Alendronate<br>* 70mg per oral (po) weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) | The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment. | Baseline and 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) | Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment. | Baseline and 9 months | 
| Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula) | Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment. | Baseline and 9 months | 
| Relative Change From Baseline in Actual GFR (Using CG Formula) | Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment. | Baseline and 9 months | 
| Absolute Change From Baseline in Mean Serum Creatinine. |  | Baseline and 9 months | 
| Relative Change From Baseline in Mean Serum Creatinine. |  | Baseline and 9 months | 
| Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio. |  | Baseline and 9 months | 
| Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio. | The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values. | Baseline and 9 months |