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

This study has been completed.
Astellas Pharma Inc
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd Identifier:
First received: September 13, 2005
Last updated: October 10, 2012
Last verified: October 2012
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-Blind
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)

Ages Eligible for Study:   55 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00212667

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ono Pharmaceutical Co. Ltd 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

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

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on April 28, 2017