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
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, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 16, 2014