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

Primary Purpose

Primary Osteoporosis

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

ibandronic acid 0.5mg

RIS placebo

1.0mg ibandronic acid

ibandronic acid placebo

2.5mg RIS

Calcium and Vitamine D3

About this trial

This is an interventional treatment trial for Primary Osteoporosis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chubu/Kansai region
Chugoku/Kyusyu region
Hokkaido/Tohoku region
Kanto/Koshinetsu region

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Incidence of vertebral fracture

Secondary Outcome Measures

Change of bone density of lumbar spine and proximal part of femur from baseline

Change of bone absorption marker from baseline

Change of bone formation marker from baseline

Full Information

NCT ID

NCT00447915

First Posted

March 14, 2007

Last Updated

July 31, 2012

Sponsor

Chugai Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00447915

Brief Title

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

Official Title

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 -

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chugai Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1265 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

ibandronic acid 0.5mg

Intervention Description

0.5mg(i.v.)/month for 35 months

Intervention Type

Drug

Intervention Name(s)

RIS placebo

Intervention Description

0 mg(p.o.)/day for 36 months

Intervention Type

Drug

Intervention Name(s)

1.0mg ibandronic acid

Intervention Description

1.0mg(i.v.)/month for 35 months

Intervention Type

Drug

Intervention Name(s)

ibandronic acid placebo

Intervention Description

0mg(i.v.)/month for 35 months

Intervention Type

Drug

Intervention Name(s)

2.5mg RIS

Intervention Description

2.5 mg(p.o.)/day for 36 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Calcium and Vitamine D3

Intervention Description

Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months

Primary Outcome Measure Information:

Title

Incidence of vertebral fracture

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Change of bone density of lumbar spine and proximal part of femur from baseline

Time Frame

36 months

Title

Change of bone absorption marker from baseline

Time Frame

36 months

Title

Change of bone formation marker from baseline

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Toshitaka Nakamura

Organizational Affiliation

University of Occupational and Environment Health

Official's Role

Study Chair

Facility Information:

Facility Name

Chubu/Kansai region

City

Chubu/Kansai

Country

Japan

Facility Name

Chugoku/Kyusyu region

City

Chugoku/Kyusyu

Country

Japan

Facility Name

Hokkaido/Tohoku region

City

Hokkaido/Tohoku

Country

Japan

Facility Name

Kanto/Koshinetsu region

City

Kanto/Koshinetsu

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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