Clinical Trial: A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Open-Label, Muti-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and
Brief Summary: This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate [ Time Frame: Up to 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate. [ Time Frame: Up to 6 months ]
- Incidence of adverse events [ Time Frame: Up to approximately 1 year ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: November 4, 2015
Date Started: March 2004
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016