Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00532337
• Other study ID #: ONO-5334POE003
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2007
• Last updated: June 12, 2012
• Start date: October 2007

Study information

• Verified date: June 2012
• Source: Ono Pharmaceutical Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Estonia: The State Agency of MedicineNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Denmark: The Regional Committee on Biomedical Research EthicsLithuania: Bioethics CommitteeCzech Republic: Ethics CommitteeHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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:

1. 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.

2. Osteoporosis patients (T-score =-2.5) who have any vertebral fragility fracture between T4 and L4 inclusive.

3. 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.

4. Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD.

5. Patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism.

6. Other exclusion criteria as specified in the study protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis

Intervention

Drug:
• ONO-5334
Placebo - 24/mos.
• ONO-5334
100mg QD /24 months
• ONO-5334
50mg BID /24 mos.
• ONO-5334
300mg QD /24 mos.
• ONO-5334
Alendronate 70mg once weekly / 24 mos

Locations

Country	Name	City	State
Netherlands	Andromed Noord Groningen	Damsterdiep 9	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Ono Pharma USA Inc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean bone mineral density of the lumbar spine (L 1-4 BMD)		12 months	No
Secondary	Bone mineral density at hip, Biochemical markers of bone turnover		during course of treatment of 12 months	No