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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00447915
First received: March 14, 2007
Last updated: July 31, 2012
Last verified: July 2012
  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 3

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:


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 ]

Enrollment: 1265
Study Start Date: March 2007
Study Completion Date: December 2011
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 31, 2012
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 August 27, 2014