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

Hoffmann-La Roche801 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

801

Conditions

Post-Menopausal Osteoporosis

Interventions

ibandronate [Bonviva/Boniva]

Eligibility

Sex: FEMALEMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (44)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Riverside, California, United States

Unnamed facility

Lakewood, Colorado, United States

Unnamed facility

West Palm Beach, Florida, United States

Unnamed facility

Gainesville, Georgia, United States

Unnamed facility

Outcomes

Primary Outcomes

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.