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

Completed · Phase 4

Conditions studied: Post-Menopausal Osteoporosis

In brief

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.

Key facts

Study ID

NCT00503113

Run by

Hoffmann-La Roche

People needed

801

Starts

2007-07-01

Expected to finish

2010-04-01

Last updated by the study team

2011-06-17

Who can join

Age: 60 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Riverside, California, United States
• Study site — Lakewood, Colorado, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Gainesville, Georgia, United States
• Study site — Topeka, Kansas, United States
• Study site — Bethesda, Maryland, United States
• Study site — Omaha, Nebraska, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Morehead City, North Carolina, United States
• Study site — Bismarck, North Dakota, United States
• Study site — Fargo, North Dakota, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Norfolk, Virginia, United States
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Buenos Aires, Argentina
• Study site — Córdoba, Argentina
• Study site — Santa Fe, Argentina
• Study site — Brasília, Brazil

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.