NCT00447915 - Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis | Biotech Hunter

Enrollment

1,265

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

August 31, 2011

Study Completion Date

December 31, 2011

Conditions

Primary Osteoporosis

Interventions

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

Trial Locations (4)

Chubu/Kansai region, Chubu/Kansai

Chugoku/Kyusyu region, Chugoku/Kyusyu

Hokkaido/Tohoku region, Hokkaido/Tohoku

Kanto/Koshinetsu region, Kanto/Koshinetsu