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Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00212667
First received: September 13, 2005
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy and safety of ONO-5920 in patients with involutional osteoporosis.


Condition Intervention Phase
Involutional Osteoporosis
 Drug: ONO-5920
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • New fragility vertebral fracture

Secondary Outcome Measures:
  • New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spoine (L2-4 BMD), lower back pain

Estimated Enrollment: 650
Study Start Date: August 2002
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis
  2. Patients having radiographically confirmed vertebral (T4-L4) fractures
  3. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

  1. Patients having secondary osteoporosis or another condition that presents low bone mass
  2. Patients having findings on X-ray that affect evaluation of vertebral fracture
  3. Patients that have been administered bisphosphonate derivatives
  4. Other exclusion criteria as specified in the study protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212667

Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Astellas Pharma Inc
Investigators
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. LtTd.
  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
ClinicalTrials.gov Identifier: NCT00212667     History of Changes
Obsolete Identifiers: NCT00189891
Other Study ID Numbers: ONO-5920-02
Study First Received: September 13, 2005
Last Updated: October 10, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-5920, osteoporosis, bisphosphonate

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

ClinicalTrials.gov processed this record on May 22, 2013