Trial information
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 type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety study
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:
- 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.
Gender: Females
Age limits: Min: 60 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2007
Trial registration date: 07/19/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Argentina
- Buenos Aires
- Cordoba
- Santa Fe
Brazil
- Brasilia
- Curitiba
- Goiania
- Porto Alegre
- Rio De Janeiro
- Sao Paulo
- Vitoria
Mexico
- Guadalajara
- Mexico City
- Monterrey
- Obregon
- San Jerónimo Chicahualco
South Africa
- Durban
- Johannesburg
- Parow
- Port Elizabeth
- Sommerset West
Switzerland
United States
- Birmingham, AL
- Riverside, CA
- Lakewood, CO
- West Palm Beach, FL
- Gainesville, GA
- Topeka, KS
- Bethesda, MD
- Omaha, NE
- Albuquerque, NM
- Morehead City, NC
- Bismarck, ND
- Fargo, ND
- Cincinnati, OH
- Duncansville, PA
- Norfolk , VA
