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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00532337
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )

Tracking Information
First Submitted Date  ICMJE September 19, 2007
First Posted Date  ICMJE September 20, 2007
Last Update Posted Date June 13, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2008)
Mean bone mineral density of the lumbar spine (L 1-4 BMD) [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoporosis
  • Osteopenia
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2011)
285
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2007)
265
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00532337
Other Study ID Numbers  ICMJE ONO-5334POE003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
Study Sponsor  ICMJE Ono Pharma USA Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tomohiro Kuwayama Ono Pharmaceutical Co. Ltd
PRS Account Ono Pharmaceutical Co. Ltd
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP