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

• ClinicalTrials.gov Identifier: NCT00532337
• Recruitment Status: Completed
• First Posted: September 20, 2007
• Last Update Posted: June 13, 2012
• Sponsor: Ono Pharma USA Inc
• Information provided by (Responsible Party): Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )

Tracking Information

• First Submitted Date: September 19, 2007
• First Posted Date: September 20, 2007
• Last Update Posted Date: June 13, 2012
• Study Start Date: October 2007
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 25, 2008): Mean bone mineral density of the lumbar spine (L 1-4 BMD) [ Time Frame: 12 months ]
• Original Primary Outcome Measures (submitted: September 19, 2007): Mean bone mineral density of the lumbar spine (L 1-4 BMD) [ Time Frame: Bone mineral density; Time Frame 12 months ]
• Current Secondary Outcome Measures (submitted: June 25, 2008): Bone mineral density at hip, Biochemical markers of bone turnover [ Time Frame: during course of treatment of 12 months ]
• Original Secondary Outcome Measures (submitted: September 19, 2007): Bone mineral density at hip, Biochemical markers of bone turnover [ Time Frame: Biochemical markers; Time Frame - during course of treatment of 12 months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
• 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
• Brief Summary: The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Osteoporosis
• Osteopenia

Intervention

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

Study Arms

• Placebo Comparator: P
  Intervention: Drug: ONO-5334
• Experimental: E1
  Intervention: Drug: ONO-5334
• Experimental: E2
  Intervention: Drug: ONO-5334
• Experimental: E3
  Intervention: Drug: ONO-5334
• Active Comparator: A
  Intervention: Drug: ONO-5334

• Publications *: Eastell R, Nagase S, Small M, Boonen S, Spector T, Ohyama M, Kuwayama T, Deacon S. Effect of ONO-5334 on bone mineral density and biochemical markers of bone turnover in postmenopausal osteoporosis: 2-year results from the OCEAN study. J Bone Miner Res. 2014 Feb;29(2):458-66. doi: 10.1002/jbmr.2047.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 13, 2011): 285
• Original Estimated Enrollment (submitted: September 19, 2007): 265
• Study Completion Date: Not Provided
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 55 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00532337
• Other Study ID Numbers: ONO-5334POE003
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
• Study Sponsor: Ono Pharma USA Inc
• Collaborators: Not Provided

Investigators

• Study Director: Tomohiro Kuwayama; Ono Pharmaceutical Co. Ltd

• PRS Account: Ono Pharmaceutical Co. Ltd
• Verification Date: June 2012