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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier:
NCT00532337
First received: September 19, 2007
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Osteoporosis
Osteopenia
Drug: ONO-5334
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Mean bone mineral density of the lumbar spine (L 1-4 BMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone mineral density at hip, Biochemical markers of bone turnover [ Time Frame: during course of treatment of 12 months ] [ Designated as safety issue: No ]

Enrollment: 285
Study Start Date: October 2007
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Ono Pharmaceutical Co. Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )
ClinicalTrials.gov Identifier: NCT00532337     History of Changes
Other Study ID Numbers: ONO-5334POE003
Study First Received: September 19, 2007
Last Updated: June 12, 2012
Health Authority: Estonia: The State Agency of Medicine
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Denmark: The Regional Committee on Biomedical Research Ethics
Lithuania: Bioethics Committee
Czech Republic: Ethics Committee
Hungary: National Institute of Pharmacy

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-5334
osteoporosis
osteopenia

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

ClinicalTrials.gov processed this record on August 27, 2014