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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212667
First Posted: September 21, 2005
Last Update Posted: October 11, 2012
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.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
  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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes 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
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): NCT00212667


Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Astellas Pharma Inc
Investigators
Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. LtTd.
  More Information

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
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: October 11, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs