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

Post-Menopausal Osteoporosis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503113
• Other study ID #: BA20341
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2007
• Last updated: May 17, 2011
• Start date: July 2007
• Est. completion date: April 2010

Study information

• Verified date: May 2011
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post-Menopausal Osteoporosis

Intervention

Drug:
• ibandronate [Bonviva/Boniva]
3mg intravenous (iv) injection every 3 months
• ibandronate [Bonviva/Boniva]
3mg intravenous (iv) infusion every 3 months
• Alendronate
70mg per oral (po) weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Mexico,  South Africa,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Absolute Change From Baseline in Mean Serum Creatinine.		Baseline and 9 months	Yes
Secondary	Relative Change From Baseline in Mean Serum Creatinine.		Baseline and 9 months	Yes
Secondary	Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.		Baseline and 9 months	Yes
Secondary	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	Yes