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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis Osteopenia | Drug: ONO-5334 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 285 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, 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 |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | July 2010 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: P |
Drug: ONO-5334
Placebo - 24/mos. |
Experimental: E1 |
Drug: ONO-5334
100mg QD /24 months |
Experimental: E2 |
Drug: ONO-5334
50mg BID /24 mos. |
Experimental: E3 |
Drug: ONO-5334
300mg QD /24 mos. |
Active Comparator: A |
Drug: ONO-5334
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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 55 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

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
Netherlands | |
Andromed Noord Groningen | |
Damsterdiep 9, Groningen, Netherlands |
Study Director: | Tomohiro Kuwayama | Ono Pharmaceutical Co. Ltd |
Responsible Party: | Ono Pharma USA Inc |
ClinicalTrials.gov Identifier: | NCT00532337 |
Other Study ID Numbers: |
ONO-5334POE003 |
First Posted: | September 20, 2007 Key Record Dates |
Last Update Posted: | June 13, 2012 |
Last Verified: | June 2012 |
ONO-5334 osteoporosis osteopenia |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |