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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00447915
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : August 2, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 -
Study Start Date : March 2007
Primary Completion Date : August 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Incidence of vertebral fracture [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Change of bone density of lumbar spine and proximal part of femur from baseline [ Time Frame: 36 months ]
  2. Change of bone absorption marker from baseline [ Time Frame: 36 months ]
  3. Change of bone formation marker from baseline [ Time Frame: 36 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00447915     History of Changes
Other Study ID Numbers: JA19761
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: August 2, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamins
Vitamin D
Cholecalciferol
Ibandronic acid
Diphosphonates
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents