Back to resultsControlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
Primary Purpose
Osteoporosis, Osteopenia
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
ONO-5334
ONO-5334
ONO-5334
ONO-5334
ONO-5334
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring ONO-5334, osteoporosis, osteopenia
Eligibility Criteria
Inclusion Criteria:
1. 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.
Exclusion Criteria:
- 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.
- Other exclusion criteria as specified in the study protocol.
Sites / Locations
- Andromed Noord Groningen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Active Comparator
Arm Label
P
E1
E2
E3
A
Arm Description
Outcomes
Primary Outcome Measures
Mean bone mineral density of the lumbar spine (L 1-4 BMD)
Secondary Outcome Measures
Bone mineral density at hip, Biochemical markers of bone turnover
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00532337
Brief Title
Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharma USA Inc
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Osteopenia
Keywords
ONO-5334, osteoporosis, osteopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Arm Title
P
Arm Type
Placebo Comparator
Arm Title
E1
Arm Type
Experimental
Arm Title
E2
Arm Type
Experimental
Arm Title
E3
Arm Type
Experimental
Arm Title
A
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ONO-5334
Intervention Description
Placebo - 24/mos.
Intervention Type
Drug
Intervention Name(s)
ONO-5334
Intervention Description
100mg QD /24 months
Intervention Type
Drug
Intervention Name(s)
ONO-5334
Intervention Description
50mg BID /24 mos.
Intervention Type
Drug
Intervention Name(s)
ONO-5334
Intervention Description
300mg QD /24 mos.
Intervention Type
Drug
Intervention Name(s)
ONO-5334
Intervention Description
Alendronate 70mg once weekly / 24 mos
Primary Outcome Measure Information:
Title
Mean bone mineral density of the lumbar spine (L 1-4 BMD)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Bone mineral density at hip, Biochemical markers of bone turnover
Time Frame
during course of treatment of 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. 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.
Exclusion Criteria:
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.
Other exclusion criteria as specified in the study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomohiro Kuwayama
Organizational Affiliation
Ono Pharmaceutical Co. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Andromed Noord Groningen
City
Damsterdiep 9
State/Province
Groningen
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
23873670
Citation
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.
Results Reference
derived
Learn more about this trial
Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
We'll reach out to this number within 24 hrs