Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
1 other identifier
interventional
250
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2006
CompletedOctober 11, 2012
October 1, 2012
2.9 years
September 13, 2005
October 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean bone mineral density of the lumbar spine (L2-4 BMD)
Secondary Outcomes (1)
Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain
Interventions
Eligibility Criteria
You may qualify if:
- A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.
You may not qualify if:
- Patients having secondary osteoporosis or another condition that presents low bone mass.
- Patients having findings that affect measurement of lumbar spinal bone mineral density by DXA
- Patients that have been administered bisphosphonate derivatives.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hagino H, Nishizawa Y, Sone T, Morii H, Taketani Y, Nakamura T, Itabashi A, Mizunuma H, Ohashi Y, Shiraki M, Minamide T, Matsumoto T. A double-blinded head-to-head trial of minodronate and alendronate in women with postmenopausal osteoporosis. Bone. 2009 Jun;44(6):1078-84. doi: 10.1016/j.bone.2009.02.016. Epub 2009 Mar 2.
PMID: 19264155DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader, ' Development Planning
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
May 1, 2003
Primary Completion
April 1, 2006
Last Updated
October 11, 2012
Record last verified: 2012-10