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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):

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

Condition or disease Intervention/treatment Phase
Osteoporosis Osteopenia Drug: ONO-5334 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2007
Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Mean bone mineral density of the lumbar spine (L 1-4 BMD) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Bone mineral density at hip, Biochemical markers of bone turnover [ Time Frame: during course of treatment of 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes 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:

  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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532337


Locations
Netherlands
Andromed Noord Groningen
Damsterdiep 9, Groningen, Netherlands
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
Study Director: Tomohiro Kuwayama Ono Pharmaceutical Co. Ltd
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT00532337     History of Changes
Other Study ID Numbers: ONO-5334POE003
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):
ONO-5334
osteoporosis
osteopenia

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases