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

Phase 3

Completed

• Conditions: Primary Osteoporosis
• Interventions: Drug: ibandronic acid placebo; Drug: ibandronic acid 0.5mg; Drug: RIS placebo; Drug: 1.0mg ibandronic acid; Drug: 2.5mg RIS; Dietary Supplement: Calcium and Vitamine D3

• Registration Number: NCT00447915
• Lead Sponsor: Chugai Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-14
• Study First Submitted QC: 2007-03-14
• Study First Posted: 2007-03-15
• Primary Completion: 2011-08
• Study Completion: 2011-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1265

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	RIS placebo	-
1	Calcium and Vitamine D3	-
2	RIS placebo	-
2	1.0mg ibandronic acid	-
2	Calcium and Vitamine D3	-
3	ibandronic acid placebo	-
3	2.5mg RIS	-
1	ibandronic acid 0.5mg	-
3	Calcium and Vitamine D3	-

Primary Outcome Measures

Name	Time	Method
Incidence of vertebral fracture	36 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Kanto/Koshinetsu region; 🇯🇵 Kanto/Koshinetsu, Japan

Chubu/Kansai region; 🇯🇵 Chubu/Kansai, Japan

Chugoku/Kyusyu region; 🇯🇵 Chugoku/Kyusyu, Japan

Hokkaido/Tohoku region; 🇯🇵 Hokkaido/Tohoku, Japan