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

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 -

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00447915

Enrollment

1265

Registered

2007-03-15

Start date

2007-03-31

Completion date

2011-12-31

Last updated

2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Osteoporosis

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.

Interventions

DRUGibandronic acid 0.5mg

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

DRUGRIS placebo

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

DRUG1.0mg ibandronic acid

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

DRUGibandronic acid placebo

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

DRUG2.5mg RIS

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

DIETARY_SUPPLEMENTCalcium and Vitamine D3

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Incidence of vertebral fracture	36 months

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026