Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
This study has been completed.
Ono Pharma USA Inc
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
First received: September 19, 2007
Last updated: June 12, 2012
Last verified: June 2012
The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
Resource links provided by NLM:
Further study details as provided by Ono Pharmaceutical Co. Ltd:
Primary Outcome Measures:
- Mean bone mineral density of the lumbar spine (L 1-4 BMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Bone mineral density at hip, Biochemical markers of bone turnover [ Time Frame: during course of treatment of 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
|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
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