Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
A Multi-centre, Randomized, Double Blind, Parallel Group Study to Investigate Efficacy and Safety of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
1 other identifier
interventional
285
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2007
CompletedFirst Posted
Study publicly available on registry
September 20, 2007
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedJune 13, 2012
June 1, 2012
2.8 years
September 19, 2007
June 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean bone mineral density of the lumbar spine (L 1-4 BMD)
12 months
Secondary Outcomes (1)
Bone mineral density at hip, Biochemical markers of bone turnover
during course of treatment of 12 months
Study Arms (5)
P
PLACEBO COMPARATORE1
EXPERIMENTALE2
EXPERIMENTALE3
EXPERIMENTALA
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \. Osteoporosis defined as a value DXA BMD 2.5 SD or more below the young adult mean (T-score, ≤-2.5) at the lumbar spine (L1 to L4) or total hip, OR
- Osteoporosis defined as a value of DXA BMD more than 1 SD below the young adult mean, but less than 2.5 SD below this value (T-score \<-1 and \>2.5) at the lumbar spine (L1 to L4) or total hip.
You may not qualify if:
- Patients with a value of DXA BMD more that 3.5 SD below the young adult mean, (T-score \<-3.5) at the lumbar spine (L1 to L4) or total hip.
- Osteoporosis patients (T-score ≤-2.5) who have any vertebral fragility fracture between T4 and L4 inclusive.
- Osteopenia patients (T-score \<-1 and \>-2.5) who have no vertebral fragility fractures between T4 and L4 inclusive, OR
- Osteopenia patients (T-score \<-1 and \>-2.5) who have two or more vertebral fragility fractures between T4 and L4 inclusive.
- Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD.
- Patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Andromed Noord Groningen
Damsterdiep 9, Provincie Groningen, Netherlands
Related Publications (1)
Eastell R, Nagase S, Small M, Boonen S, Spector T, Ohyama M, Kuwayama T, Deacon S. Effect of ONO-5334 on bone mineral density and biochemical markers of bone turnover in postmenopausal osteoporosis: 2-year results from the OCEAN study. J Bone Miner Res. 2014 Feb;29(2):458-66. doi: 10.1002/jbmr.2047.
PMID: 23873670DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tomohiro Kuwayama
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2007
First Posted
September 20, 2007
Study Start
October 1, 2007
Primary Completion
July 1, 2010
Last Updated
June 13, 2012
Record last verified: 2012-06