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

Phase 4

Completed

• Conditions: Post-Menopausal Osteoporosis
• Interventions: Drug: ibandronate [Bonviva/Boniva]; Drug: Alendronate

• Registration Number: NCT00503113
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-03-31
• Status Verified: 2011-05
• Results First Submitted QC: 2011-05-17
• Last Update Submitted: 2011-05-17
• Results First Posted: 2011-06-17
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 801

Inclusion Criteria

• female patients, >=60 years of age;
• >=5 years postmenopausal;
• confirmed osteoporosis, at increased risk for renal disease.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ibandronate [Bonviva/Boniva]	-
1	ibandronate [Bonviva/Boniva]	-
3	Alendronate	-

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)	Baseline and 9 months	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.

Secondary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)	Baseline and 9 months	Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault \[CG\] formula) after 9 months (or 40 weeks) of treatment.
Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)	Baseline and 9 months	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.
Relative Change From Baseline in Actual GFR (Using CG Formula)	Baseline and 9 months	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.
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.	Baseline and 9 months	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.