drugset / Trial / NCT00447915

Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis

NCT00447915

Phase 3 Completed 1265 enrolled Chugai Pharmaceutical
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the efficacy and safety of R484iv by intravenous intermittent administration to patients with primary osteoporosis in comparison with sodium risedronate hydrate (RIS) by oral administration every day. To evaluate also the dose response of R484iv.

Timeline

Start
2007-03
Primary completion
2011-08
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibandronic acid Unknown 0.5 mg Intravenous
Subject Ibandronic acid Unknown 1 mg Intravenous
Comparator Sodium Risedronate Hydrate Unknown 2.5 mg Oral

Indications