drugset / Trial / NCT00405392

Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis

NCT00405392 ↗

Phase 4 Completed 365 enrolled GlaxoSmithKline
RandomizedCrossoverOpen-labelTreatment

Summary

This is a randomized open label, multi-centre study for Korean women with postmenopausal osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or the once-weekly dosing of risedronate. Eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly regimen. Treatment period consists of 3 month with ibandronate 150mg and additional 12 week with risedronate 35 mg or vice versa. After taking the first interventional medicine for 3 months or 12 weeks completely, a subject changes the treatment arm. There is no washout period.

Timeline

Start
2007-03-22
Primary completion
2008-05-27
Completion
2008-05-27

Outcome

Met primary endpoint

registry analysis (superiority or other test); Ibandronate 150 mg Once Monthly vs Risedronate 35 mg Once Weekly; p <0.0001; Chi-squared NCT00405392 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibandronate Other / unclassified 150 mg —