NCT00048061

MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis

Randomized, Double-blind, Double Dummy, Parallel Groups, Multicenter Study to Compare the Efficacy and Safety of Monthly Oral Administration of 100 mg and 150 mg Ibandronate With 2.5 mg Daily Oral Ibandronate in Postmenopausal Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,609 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the efficacy and safety of different treatment regimens of oral Bonviva tablets in women with post-menopausal osteoporosis. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Conditions

• Post Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Ibandronate [Bonviva/Boniva]	2.5mg po daily
DRUG	Ibandronate [Bonviva/Boniva]	100mg po monthly on a single day
DRUG	Ibandronate [Bonviva/Boniva]	100mg po monthly over 2 consecutive days
DRUG	Ibandronate [Bonviva/Boniva]	150mg po monthly
DIETARY_SUPPLEMENT	Calcium	500 mg/day
DIETARY_SUPPLEMENT	Vitamin D	400 IU/day

Timeline

• Start date: 2002-04-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2002-10-25
• Last updated: 2018-03-29
• Results posted: 2016-05-30

Locations

68 sites across 19 countries: United States, Australia, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Mexico, Norway, Poland, Romania, South Africa, Spain, Switzerland, United Kingdom