A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.

Completed · Phase 4

Conditions studied: Post Menopausal Osteoporosis

In brief

This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00377234

Run by

Hoffmann-La Roche

People needed

356

Starts

2006-05-01

Expected to finish

2008-08-01

Last updated by the study team

2016-08-01

Who can join

Age: 55 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ambulatory women with post-menopausal osteoporosis;
• patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).

You may not qualify if…

• malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;
• inability to stand or sit upright for at least 60 minutes;
• disease/disorder/treatment with drugs known to influence bone metabolism.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — San Diego, California, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Leesburg, Florida, United States
• Study site — Merritt Island, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Spring Hill, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Douglasville, Georgia, United States
• Study site — Gainesville, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Madisonville, Kentucky, United States
• Study site — Bethesda, Maryland, United States
• Study site — Missoula, Montana, United States
• Study site — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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