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ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

This study has been completed.
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: November 18, 2008
Last updated: April 30, 2015
Last verified: April 2015
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
Bone Loss, Age-Related
Drug: YM529 / ONO-5920
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Time-course changes in the percent change of bone metabolism markers [ Time Frame: Through the treatment period ]
  • Time-course changes in the total femoral bone mineral density by the DXA method [ Time Frame: Through the treatment period ]
  • Assessment of adverse events, lab test values [ Time Frame: Through the treatment period ]
  • Frequency of fracture [ Time Frame: At the final evaluation point ]

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
Other Names:
  • YM529
  • ONO-5920
  • Minodronic acid
Experimental: 2. Monthly - Dose 2
Monthly intermittent administration, dose 2
Drug: YM529 / ONO-5920
Other Names:
  • YM529
  • ONO-5920
  • Minodronic acid
Active Comparator: 3. Daily
Daily administration
Drug: YM529 / ONO-5920
Other Names:
  • YM529
  • ONO-5920
  • Minodronic acid


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00794443

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

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00794443     History of Changes
Other Study ID Numbers: 529-CL-028
Study First Received: November 18, 2008
Last Updated: April 30, 2015

Keywords provided by Astellas Pharma Inc:
Bone mineral density
Minodronic acid

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on April 28, 2017