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ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

This study has been completed.
Sponsor:
Collaborator:
Ono Pharma USA Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00794443
First received: November 18, 2008
Last updated: July 8, 2010
Last verified: July 2010
History of Changes

November 18, 2008
July 8, 2010
November 2008
April 2010   (final data collection date for primary outcome measure)
Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method [ Time Frame: At the final evaluation point ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00794443 on ClinicalTrials.gov Archive Site
  • Time-course changes in the percent change of bone metabolism markers [ Time Frame: Through the treatment period ] [ Designated as safety issue: No ]
  • Time-course changes in the total femoral bone mineral density by the DXA method [ Time Frame: Through the treatment period ] [ Designated as safety issue: No ]
  • Assessment of adverse events, lab test values [ Time Frame: Through the treatment period ] [ Designated as safety issue: No ]
  • Frequency of fracture [ Time Frame: At the final evaluation point ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients
A Multi-center Double-blind Parallel-group Comparison Study in Involutional Osteoporosis Patients to Examine the Efficacy and Safety of ONO-5920/YM529 Monthly Intermittent Formulation With Its Daily Formulation.

This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Osteoporosis
  • Bone Loss, Age-Related
Drug: YM529 / ONO-5920
Oral
Other Names:
  • YM529
  • ONO-5920
  • Minodronic acid
  • Experimental: 1. Monthly - Dose 1
    Monthly intermittent administration, dose 1
    Intervention: Drug: YM529 / ONO-5920
  • Experimental: 2. Monthly - Dose 2
    Monthly intermittent administration, dose 2
    Intervention: Drug: YM529 / ONO-5920
  • Active Comparator: 3. Daily
    Daily administration
    Intervention: Drug: YM529 / ONO-5920
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
692
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients whose bone mineral density is <70% of Young Adult Mean (YAM), or <80% of YAM who have fragile fracture history
  • Patients can walk on his/her own
  • Written informed consent has been obtained from the patient.

Exclusion Criteria:

  • Sequential osteoporosis patients or patients with other disorders showing low bone mass
  • Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method
  • Patients who are unable to keep raising or standing for ≥30 min
  • Patients with peptic ulcer
  • Patients who have experienced anamnesis or gastrectomy (total extraction)
Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00794443
529-CL-028, ONO-5920-05
Not Provided
Director, Astellas Pharma Inc.
Astellas Pharma Inc
Ono Pharma USA Inc
Study Director: Toshiomi Minamide Ono Pharmaceutical Co. Ltd
Study Chair: Central Contact Clinical Development Administration Dept., Astellas Pharma Inc.
Astellas Pharma Inc
July 2010

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