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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
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Bone Loss, Age-Related
Drug: YM529 / ONO-5920
Phase 2
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: 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.

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 692
Study Start Date: November 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Monthly - Dose 1
Monthly intermittent administration, dose 1
Drug: YM529 / ONO-5920
Oral
Other Names:
  • YM529
  • ONO-5920
  • Minodronic acid
Experimental: 2. Monthly - Dose 2
Monthly intermittent administration, dose 2
Drug: YM529 / ONO-5920
Oral
Other Names:
  • YM529
  • ONO-5920
  • Minodronic acid
Active Comparator: 3. Daily
Daily administration
Drug: YM529 / ONO-5920
Oral
Other Names:
  • YM529
  • ONO-5920
  • Minodronic acid

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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: NCT00794443

Locations
Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyusyu, Japan
Shikoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Ono Pharma USA Inc
Investigators
Study Director: Toshiomi Minamide Ono Pharmaceutical Co. Ltd
Study Chair: Central Contact Clinical Development Administration Dept., Astellas Pharma Inc.
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma Inc.
ClinicalTrials.gov Identifier: NCT00794443     History of Changes
Other Study ID Numbers: 529-CL-028, ONO-5920-05
Study First Received: November 18, 2008
Last Updated: July 8, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
ONO-5920
YM529
Bone mineral density
Minodronic acid

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 20, 2014