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

Study Overview
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Brief Summary
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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.

Official Title
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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 -

Conditions
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Primary Osteoporosis

Intervention / Treatment
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* Drug: ibandronic acid 0.5mg
* Drug: RIS placebo
* Drug: 1.0mg ibandronic acid
* Drug: ibandronic acid placebo
* Drug: 2.5mg RIS
* Dietary Supplement: Calcium and Vitamine D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ibandronic acid 0.5mg<br>* 0.5mg(i.v.)/month for 35 months<br>Drug: RIS placebo<br>* 0 mg(p.o.)/day for 36 months<br>Dietary Supplement: Calcium and Vitamine D3<br>* Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months<br>|
| Experimental: 2<br> | Drug: RIS placebo<br>* 0 mg(p.o.)/day for 36 months<br>Drug: 1.0mg ibandronic acid<br>* 1.0mg(i.v.)/month for 35 months<br>Dietary Supplement: Calcium and Vitamine D3<br>* Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months<br>|
| Active Comparator: 3<br> | Drug: ibandronic acid placebo<br>* 0mg(i.v.)/month for 35 months<br>Drug: 2.5mg RIS<br>* 2.5 mg(p.o.)/day for 36 months<br>Dietary Supplement: Calcium and Vitamine D3<br>* Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of vertebral fracture |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |