- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00212628
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
June 12, 2012 updated by: Ono Pharmaceutical Co. Ltd
The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
444
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chubu, Japan
- Chubu Region Facility
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Chugoku, Japan
- Chugoku Region Facility
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Hokkaido, Japan
- Hokkaido Region Facility
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Hokuriku, Japan
- Hokuriku Region Facility
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Kanto, Japan
- Kanto Region Facility
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Kinki, Japan
- Kinki Region Facility
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Kyushu, Japan
- Kyushu Region Facility
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Shikoku Region Facility, Japan
- Shikoku Region Facility
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Tohoku, Japan
- Tohoku Region Facility
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients who was included in study ONO-5920-02 and completed the medication for two years
- Other inclusion criteria as specified in the study protocol
Exclusion Criteria:
- Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator
- Patients having secondary osteoporosis or another condition that presents low bone mass
- Other exclusion criteria as specified in the study protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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New fragility vertebral fracture
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Secondary Outcome Measures
Outcome Measure |
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New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spine (L2-4 BMD), lower back pain.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Project Leader, Development Planning, Ono Pharmaceutical Co. Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 21, 2005
Study Record Updates
Last Update Posted (Estimate)
June 14, 2012
Last Update Submitted That Met QC Criteria
June 12, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONO-5920-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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