Back to resultsONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients
Primary Purpose
Osteoporosis, Bone Loss, Age-Related
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
YM529 / ONO-5920
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring ONO-5920, YM529, Bone mineral density, Minodronic acid
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1. Monthly - Dose 1
2. Monthly - Dose 2
3. Daily
Arm Description
Monthly intermittent administration, dose 1
Monthly intermittent administration, dose 2
Daily administration
Outcomes
Primary Outcome Measures
Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method
Secondary Outcome Measures
Time-course changes in the percent change of bone metabolism markers
Time-course changes in the total femoral bone mineral density by the DXA method
Assessment of adverse events, lab test values
Frequency of fracture
Full Information
NCT ID
NCT00794443
First Posted
November 18, 2008
Last Updated
April 30, 2015
Sponsor
Astellas Pharma Inc
Collaborators
Ono Pharmaceutical Co. Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00794443
Brief Title
ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Ono Pharmaceutical Co. Ltd
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Bone Loss, Age-Related
Keywords
ONO-5920, YM529, Bone mineral density, Minodronic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
692 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Monthly - Dose 1
Arm Type
Experimental
Arm Description
Monthly intermittent administration, dose 1
Arm Title
2. Monthly - Dose 2
Arm Type
Experimental
Arm Description
Monthly intermittent administration, dose 2
Arm Title
3. Daily
Arm Type
Active Comparator
Arm Description
Daily administration
Intervention Type
Drug
Intervention Name(s)
YM529 / ONO-5920
Other Intervention Name(s)
YM529, ONO-5920, Minodronic acid
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method
Time Frame
At the final evaluation point
Secondary Outcome Measure Information:
Title
Time-course changes in the percent change of bone metabolism markers
Time Frame
Through the treatment period
Title
Time-course changes in the total femoral bone mineral density by the DXA method
Time Frame
Through the treatment period
Title
Assessment of adverse events, lab test values
Time Frame
Through the treatment period
Title
Frequency of fracture
Time Frame
At the final evaluation point
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiomi Minamide
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Clinical Development Administration Dept., Astellas Pharma Inc.
Official's Role
Study Chair
Facility Information:
City
Hokkaido
Country
Japan
City
Kansai
Country
Japan
City
Kantou
Country
Japan
City
Kyusyu
Country
Japan
City
Shikoku
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch.jsp
Description
Link to Results on JAPIC - enter 150712 in the JapicCTI-RNo. field (Japanese record)
Learn more about this trial
ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients
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