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 More Information
No publications provided
| 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:
|
Bone Diseases, Metabolic Osteoporosis Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013