Trial Information

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

Status: Recruiting

Protocol Number: BA20341

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific 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.

Brief Summary: This 3 arm study will evaluate renal safety after administration of an intravenous 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 i.v. by a) injection or b)infusion once every 3 months, or alendronate 70mg p.o. weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 801.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety

Study Type:

Condition: Post-Menopausal Osteoporosis

Intervention Type: Drug

Intervention Name: ibandronate [Bonviva/Boniva]

Primary Outcome: 1. Change from baseline in actual GFR Time frame: 9 months

Key Secondary Outcomes: 1. Relative and absolute change in mean actual GFR, serum creatinine and urine albumin-creatinine ratio Time frame: 9 months

Inclusion Criteria:

Exclusion Criteria:

Gender: Females

Age Limits: Min: 60 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: July, 2007

Trial Registration Date: 07/19/2007

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:49:52 PM