NCT00129623

A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

Double-blind, Placebo-controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of Oral Ibandronate Once Monthly in Postmenopausal Women With Osteopenia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Conditions

• Post-Menopausal Osteopenia

Interventions

Type	Name	Description
DRUG	Placebo	po monthly for 1 year
DRUG	ibandronate [Bonviva/Boniva]	150mg po monthly for 1 year

Timeline

• Start date: 2005-12-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-08-12
• Last updated: 2016-01-11
• Results posted: 2016-01-11

Locations

12 sites across 1 country: United States