NCT00447915

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

Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Comparative Study With Sodium Risedronate Hydrate(RIS) With Vertebral Fracture as an Index -

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,265 (actual)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Osteoporosis

Interventions

Type	Name	Description
DRUG	ibandronic acid 0.5mg	0.5mg(i.v.)/month for 35 months
DRUG	RIS placebo	0 mg(p.o.)/day for 36 months
DRUG	1.0mg ibandronic acid	1.0mg(i.v.)/month for 35 months
DRUG	ibandronic acid placebo	0mg(i.v.)/month for 35 months
DRUG	2.5mg RIS	2.5 mg(p.o.)/day for 36 months
DIETARY_SUPPLEMENT	Calcium and Vitamine D3	Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months

Timeline

• Start date: 2007-03-01
• Primary completion: 2011-08-01
• Completion: 2011-12-01
• First posted: 2007-03-15
• Last updated: 2012-08-02

Locations

4 sites across 1 country: Japan