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

A Multi-centre, Randomized, Double Blind, Parallel Group Study to Investigate Efficacy and Safety of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis

Sponsors

Lead Sponsor: Ono Pharma USA Inc

Source Ono Pharmaceutical Co. Ltd
Brief Summary

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

Overall Status Completed
Start Date October 2007
Primary Completion Date July 2010
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean bone mineral density of the lumbar spine (L 1-4 BMD) 12 months
Secondary Outcome
Measure Time Frame
Bone mineral density at hip, Biochemical markers of bone turnover during course of treatment of 12 months
Enrollment 285
Condition
Intervention

Intervention Type: Drug

Intervention Name: ONO-5334

Description: Placebo - 24/mos.

Arm Group Label: P

Intervention Type: Drug

Intervention Name: ONO-5334

Description: 100mg QD /24 months

Arm Group Label: E1

Intervention Type: Drug

Intervention Name: ONO-5334

Description: 50mg BID /24 mos.

Arm Group Label: E2

Intervention Type: Drug

Intervention Name: ONO-5334

Description: 300mg QD /24 mos.

Arm Group Label: E3

Intervention Type: Drug

Intervention Name: ONO-5334

Description: Alendronate 70mg once weekly / 24 mos

Arm Group Label: A

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:

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.

Gender: Female

Minimum Age: 55 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Tomohiro Kuwayama Study Director Ono Pharmaceutical Co. Ltd
Location
Facility: Andromed Noord Groningen
Location Countries

Netherlands

Verification Date

June 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: P

Type: Placebo Comparator

Label: E1

Type: Experimental

Label: E2

Type: Experimental

Label: E3

Type: Experimental

Label: A

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov