Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00532337|
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : June 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Osteopenia||Drug: ONO-5334||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||285 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multi-centre, Randomized, Double Blind, Parallel Group Study to Investigate Efficacy and Safety of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||July 2010|
|Placebo Comparator: P||
Placebo - 24/mos.
100mg QD /24 months
50mg BID /24 mos.
300mg QD /24 mos.
|Active Comparator: A||
Alendronate 70mg once weekly / 24 mos
- Mean bone mineral density of the lumbar spine (L 1-4 BMD) [ Time Frame: 12 months ]
- Bone mineral density at hip, Biochemical markers of bone turnover [ Time Frame: during course of treatment of 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532337
|Andromed Noord Groningen|
|Damsterdiep 9, Groningen, Netherlands|
|Study Director:||Tomohiro Kuwayama||Ono Pharmaceutical Co. Ltd|