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

NCT00447915 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1265

Last updated 2012-08-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Chugai Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Toshitaka Nakamura · University of Occupational and Environment Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-08-31
Completion
2011-12-31

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00447915 on ClinicalTrials.gov