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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
History of Changes

March 14, 2007
July 31, 2012
March 2007
August 2011   (final data collection date for primary outcome measure)
Incidence of vertebral fracture [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Incidence of vertebral fracture
Complete list of historical versions of study NCT00447915 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change of bone density of lumbar spine and proximal part of femur from baseline
  • Change of bone absorption marker from baseline
  • Change of bone formation marker from baseline
Not Provided
Not Provided
 
Phase II/III Clinical Study of R484iv (Ibandronic Acid) for Primary Osteoporosis
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 -

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Primary Osteoporosis
  • Drug: ibandronic acid 0.5mg
    0.5mg(i.v.)/month for 35 months
  • Drug: RIS placebo
    0 mg(p.o.)/day for 36 months
  • Drug: 1.0mg ibandronic acid
    1.0mg(i.v.)/month for 35 months
  • 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
  • Experimental: 1
    Interventions:
    • Drug: ibandronic acid 0.5mg
    • Drug: RIS placebo
    • Dietary Supplement: Calcium and Vitamine D3
  • Experimental: 2
    Interventions:
    • Drug: RIS placebo
    • Drug: 1.0mg ibandronic acid
    • Dietary Supplement: Calcium and Vitamine D3
  • Active Comparator: 3
    Interventions:
    • Drug: ibandronic acid placebo
    • Drug: 2.5mg RIS
    • Dietary Supplement: Calcium and Vitamine D3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1265
December 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00447915
JA19761
No
Chugai Pharmaceutical
Chugai Pharmaceutical
Not Provided
Study Chair: Toshitaka Nakamura University of Occupational and Environment Health
Chugai Pharmaceutical
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP