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

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Primary Osteoporosis

Treatments: Drug: 1.0mg ibandronic acid; Drug: 2.5mg RIS; Drug: ibandronic acid placebo; Drug: ibandronic acid 0.5mg; Dietary Supplement: Calcium and Vitamine D3; Drug: RIS placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447915

JA19761

Details and patient eligibility

About

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.

Enrollment: 1,265 patients

Sex: All

Ages: 60+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,265 participants in 3 patient groups

1

Experimental group

Treatment:

Drug: ibandronic acid 0.5mg

Dietary Supplement: Calcium and Vitamine D3

Drug: RIS placebo

2

Experimental group

Treatment:

Dietary Supplement: Calcium and Vitamine D3

Drug: RIS placebo

Drug: 1.0mg ibandronic acid

3

Active Comparator group

Treatment:

Drug: ibandronic acid placebo

Dietary Supplement: Calcium and Vitamine D3

Drug: 2.5mg RIS