drugset / Trial / NCT00545207

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

NCT00545207

Phase 3 Completed 150 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This 2 arm study will compare the effect of oral Bonviva (150mg, monthly) and placebo on parameters of bone micro-architecture, assessed by CT scan, bone turnover and bone mineral density. Patients will be randomized to receive either Bonviva 150mg po or placebo monthly, and measurements will be taken at baseline, and at intervals over 2 years. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Timeline

Start
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibandronate Other / unclassified 150 mg Oral

Indications

No indication recorded.