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Sponsors and Collaborators: |
Astellas Pharma Inc Ono Pharma |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00794443 |
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 |
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Osteoporosis Bone Loss, Age-Related |
Drug: YM529 / ONO-5920 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 600 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1. Monthly - Dose 1: Experimental
Monthly intermittent administration, dose 1
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Drug: YM529 / ONO-5920
Oral
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2. Monthly - Dose 2: Experimental
Monthly intermittent administration, dose 2
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Drug: YM529 / ONO-5920
Oral
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3. Daily: Active Comparator
Daily administration
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Drug: YM529 / ONO-5920
Oral
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Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kinya Morimoto | km.morimoto@ono.co.jp | |
Contact: Clinical Development Administration Dept. | clinicaltrials_info@jp.astellas.com |
Japan | |
Recruiting | |
Hokkaido, Japan | |
Recruiting | |
Kantou, Japan | |
Recruiting | |
Kansai, Japan | |
Recruiting | |
Shikoku, Japan | |
Recruiting | |
Kyusyu, Japan |
Study Director: | Toshiomi Minamide | Ono Pharma |
Study Chair: | Central Contact | Clinical Development Administration Dept., Astellas Pharma Inc. |
Responsible Party: | Astellas Pharma Inc. ( Director ) |
Study ID Numbers: | 529-CL-028, ONO-5920-05 |
Study First Received: | November 18, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00794443 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
ONO-5920 YM529 Bone mineral density Minodronic acid |
Musculoskeletal Diseases Osteoporosis, Postmenopausal Osteoporosis Bone Diseases, Metabolic Bone Diseases |