Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Primary Purpose
Involutional Osteoporosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ONO-5920
Sponsored by
About this trial
This is an interventional treatment trial for Involutional Osteoporosis focused on measuring ONO-5920, osteoporosis, bisphosphonate
Eligibility Criteria
Inclusion Criteria: Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis Patients having radiographically confirmed vertebral (T4-L4) fractures Other inclusion criteria as specified in the study protocol Exclusion Criteria: Patients having secondary osteoporosis or another condition that presents low bone mass Patients having findings on X-ray that affect evaluation of vertebral fracture Patients that have been administered bisphosphonate derivatives Other exclusion criteria as specified in the study protocol
Sites / Locations
Outcomes
Primary Outcome Measures
New fragility vertebral fracture
Secondary Outcome Measures
New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spoine (L2-4 BMD), lower back pain
Full Information
NCT ID
NCT00212667
First Posted
September 13, 2005
Last Updated
October 10, 2012
Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT00212667
Brief Title
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Official Title
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharmaceutical Co. Ltd
Collaborators
Astellas Pharma Inc
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Involutional Osteoporosis
Keywords
ONO-5920, osteoporosis, bisphosphonate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
650 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ONO-5920
Primary Outcome Measure Information:
Title
New fragility vertebral fracture
Secondary Outcome Measure Information:
Title
New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spoine (L2-4 BMD), lower back pain
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis
Patients having radiographically confirmed vertebral (T4-L4) fractures
Other inclusion criteria as specified in the study protocol
Exclusion Criteria:
Patients having secondary osteoporosis or another condition that presents low bone mass
Patients having findings on X-ray that affect evaluation of vertebral fracture
Patients that have been administered bisphosphonate derivatives
Other exclusion criteria as specified in the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Project Leader, Development Planning
Organizational Affiliation
Ono Pharmaceutical Co. LtTd.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19101754
Citation
Matsumoto T, Hagino H, Shiraki M, Fukunaga M, Nakano T, Takaoka K, Morii H, Ohashi Y, Nakamura T. Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study. Osteoporos Int. 2009 Aug;20(8):1429-37. doi: 10.1007/s00198-008-0816-7. Epub 2008 Dec 20.
Results Reference
derived
Learn more about this trial
Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan
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