NCT00377234

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

Randomized, Open-label, Multi-center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once Monthly Ibandronate and Once Weekly Risedronate. A Six Month, Two-sequence and Two-period Crossover Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Post Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Risedronate	35mg po weekly for 12 weeks
DRUG	ibandronate [Bonviva/Boniva]	150mg po monthly for 3 months

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-09-18
• Last updated: 2016-08-01
• Results posted: 2015-07-22

Locations

48 sites across 1 country: United States