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

July 31, 2012 updated by: Chugai Pharmaceutical

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 -

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1265

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu/Kansai, Japan
        • Chubu/Kansai region
      • Chugoku/Kyusyu, Japan
        • Chugoku/Kyusyu region
      • Hokkaido/Tohoku, Japan
        • Hokkaido/Tohoku region
      • Kanto/Koshinetsu, Japan
        • Kanto/Koshinetsu region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with fragile bone fracture
  • Patients in whom either of study site analysis value of bone density of lumbar spine, proximal part of femur or neck of femur is less than 80% of young adult mean (YAM).
  • Patients with 1 - 5 bone fractures in 4th thoracic spine (Th4) - 4th lumbar spine (L4)
  • Ambulatory

Exclusion Criteria:

  • Patients with disease lowering bone volume secondarily (secondary osteoporosis)
  • Patients receiving at least one time of of oral bisphosphonate preparations within 6 months before the start of administration of the study drug
  • Patient with disorder delaying the passage of food through esophagus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: ibandronic acid 0.5mg
0.5mg(i.v.)/month for 35 months
Drug: RIS placebo
0 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
EXPERIMENTAL: 2
Drug: RIS placebo
0 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
Drug: 1.0mg ibandronic acid
1.0mg(i.v.)/month for 35 months
ACTIVE_COMPARATOR: 3
Dietary supplement: Calcium and Vitamine D3
Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of vertebral fracture
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change of bone density of lumbar spine and proximal part of femur from baseline
Time Frame: 36 months
36 months
Change of bone absorption marker from baseline
Time Frame: 36 months
36 months
Change of bone formation marker from baseline
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharmaceutical

Investigators

  • Study Chair: Toshitaka Nakamura, University of Occupational and Environment Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

March 14, 2007

First Submitted That Met QC Criteria

March 14, 2007

First Posted (ESTIMATE)

March 15, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 2, 2012

Last Update Submitted That Met QC Criteria

July 31, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JA19761

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe