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

Chugai Pharmaceutical1,265 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,265

Conditions

Primary Osteoporosis

Interventions

ibandronic acid 0.5mgDRUG

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

RIS placeboDRUG

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

1.0mg ibandronic acidDRUG

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

ibandronic acid placebo

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (4)

Chubu/Kansai region

Chubu/Kansai, Japan

Chugoku/Kyusyu region

Chugoku/Kyusyu, Japan

Hokkaido/Tohoku region

Hokkaido/Tohoku, Japan

Kanto/Koshinetsu region

Kanto/Koshinetsu, Japan

Outcomes

Primary Outcomes

Incidence of vertebral fracture

Time frame: 36 months

Secondary Outcomes

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

Time frame: 36 months

Change of bone absorption marker from baseline

Time frame: 36 months

Change of bone formation marker from baseline

Time frame: 36 months

Data from ClinicalTrials.gov

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