NCT00447915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,265

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

4.4 years

First QC Date

March 14, 2007

Last Update Submit

July 31, 2012

Conditions

Primary Osteoporosis

Outcome Measures

Primary Outcomes (1)

  • Incidence of vertebral fracture

    36 months

Secondary Outcomes (3)

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

    36 months

  • Change of bone absorption marker from baseline

    36 months

  • Change of bone formation marker from baseline

    36 months

Study Arms (3)

1

EXPERIMENTAL
Drug: ibandronic acid 0.5mgDrug: RIS placeboDietary Supplement: Calcium and Vitamine D3

2

EXPERIMENTAL
Drug: RIS placeboDrug: 1.0mg ibandronic acidDietary Supplement: Calcium and Vitamine D3

3

ACTIVE COMPARATOR
Drug: ibandronic acid placeboDrug: 2.5mg RISDietary Supplement: Calcium and Vitamine D3

Interventions

ibandronic acid 0.5mgDRUG

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

1
RIS placeboDRUG

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

12
1.0mg ibandronic acidDRUG

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

2
ibandronic acid placeboDRUG

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

3
2.5mg RISDRUG

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

3
Calcium and Vitamine D3DIETARY_SUPPLEMENT

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

123

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chubu/Kansai region

Chubu/Kansai, Japan

Location

Chugoku/Kyusyu region

Chugoku/Kyusyu, Japan

Location

Hokkaido/Tohoku region

Hokkaido/Tohoku, Japan

Location

Kanto/Koshinetsu region

Kanto/Koshinetsu, Japan

Location

MeSH Terms

Interventions

Ibandronic AcidCalcium

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Toshitaka Nakamura

    University of Occupational and Environment Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2007

First Posted

March 15, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

JP(4)