Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis - Full Text View

Sponsor:	Chugai Pharmaceutical
Information provided by:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00447915

Purpose

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.

Condition	Intervention	Phase
Primary Osteoporosis	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	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Calcium Fractures Osteoporosis Vitamin E

Drug Information available for: alpha-Tocopherol DL-alpha-Tocopherol Ibandronic acid Ibandronate sodium Calcium gluconate Vitamin E Tocopherols Tocotrienol

U.S. FDA Resources

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

Incidence of vertebral fracture [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change of bone density of lumbar spine and proximal part of femur from baseline [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Change of bone absorption marker from baseline [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Change of bone formation marker from baseline [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1200
Study Start Date:	March 2007
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: ibandronic acid 0.5mg 0.5mg(i.v.)/month for 35 months Drug: RIS placebo 0 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
Experimental: 2	Drug: RIS placebo 0 mg(p.o.)/day for 36 months Drug: 1.0mg ibandronic acid 1.0mg(i.v.)/month for 35 months Dietary Supplement: Calcium and Vitamine D3 Calcium 305 mg and Vitamine D3 200IU(p.o.)/day for 36 months
Active Comparator: 3	Drug: ibandronic acid placebo 0mg(i.v.)/month for 35 months Drug: 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

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447915

Locations

Japan
Chubu/Kansai region
Chubu/Kansai, Japan
Chugoku/Kyusyu region
Chugoku/Kyusyu, Japan
Hokkaido/Tohoku region
Hokkaido/Tohoku, Japan
Kanto/Koshinetsu region
Kanto/Koshinetsu, Japan

Sponsors and Collaborators

Chugai Pharmaceutical

Investigators

Study Chair:

Toshitaka Nakamura

University of Occupational and Environment Health

More Information

No publications provided

Responsible Party:	Chugai Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00447915 History of Changes
Other Study ID Numbers:	JA19761
Study First Received:	March 14, 2007
Last Updated:	February 1, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Ibandronic acid
Diphosphonates

Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on February 09, 2012