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

Primary Osteoporosis Clinical Trial

Official title:

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 -

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447915
• Other study ID #: JA19761
• Status: Completed
• Phase: Phase 3
• First received: March 14, 2007
• Last updated: July 31, 2012
• Start date: March 2007
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1265
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Primary Osteoporosis

Intervention

Drug:
• ibandronic acid 0.5mg
0.5mg(i.v.)/month for 35 months
• RIS placebo
0 mg(p.o.)/day for 36 months
• 1.0mg ibandronic acid
1.0mg(i.v.)/month for 35 months
• ibandronic acid placebo
0mg(i.v.)/month for 35 months
• 2.5mg RIS
2.5 mg(p.o.)/day for 36 months

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

Locations

Country	Name	City	State
Japan	Chubu/Kansai region	Chubu/Kansai
Japan	Chugoku/Kyusyu region	Chugoku/Kyusyu
Japan	Hokkaido/Tohoku region	Hokkaido/Tohoku
Japan	Kanto/Koshinetsu region	Kanto/Koshinetsu

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of vertebral fracture		36 months	No
Secondary	Change of bone density of lumbar spine and proximal part of femur from baseline		36 months	No
Secondary	Change of bone absorption marker from baseline		36 months	No
Secondary	Change of bone formation marker from baseline		36 months	No