Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
This study has been completed.
Sponsor:
Ono Pharma USA Inc
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT00532337
First received: September 19, 2007
Last updated: June 12, 2012
Last verified: June 2012
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Purpose
The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoporosis Osteopenia |
Drug: ONO-5334 |
Phase 2 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 285 |
| Study Start Date: | October 2007 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 55 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532337
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532337
Locations
| Netherlands | |
| Andromed Noord Groningen | |
| Damsterdiep 9, Groningen, Netherlands | |
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
| Study Director: | Tomohiro Kuwayama | Ono Pharmaceutical Co. Ltd |
More Information
No publications provided by Ono Pharmaceutical Co. Ltd
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ) |
| ClinicalTrials.gov Identifier: | NCT00532337 History of Changes |
| Other Study ID Numbers: | ONO-5334POE003 |
| Study First Received: | September 19, 2007 |
| Last Updated: | June 12, 2012 |
| Health Authority: | Estonia: The State Agency of Medicine Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Denmark: The Regional Committee on Biomedical Research Ethics Lithuania: Bioethics Committee Czech Republic: Ethics Committee Hungary: National Institute of Pharmacy |
Keywords provided by Ono Pharmaceutical Co. Ltd:
|
ONO-5334 osteoporosis osteopenia |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases Bone Diseases, Metabolic Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on March 03, 2015