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

This study has been completed.

First Received: September 13, 2005 Last Updated: September 14, 2006 History of Changes

Sponsors and Collaborators:	Ono Pharma Astellas Pharma Inc
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00212667

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 III

MedlinePlus related topics: Osteoporosis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Further study details as provided by Ono Pharma:

Primary Outcome Measures:

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

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients having secondary osteoporosis or another condition that presents low bone mass
Patients having findings on X-ray that affect evaluation of vertebral fracture
Patients that have been administered bisphosphonate derivatives
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 Pharma

Astellas Pharma Inc

Investigators

Study Director:

Project Leader, Development Planning

Ono Pharmaceutical Co. LtTd.

More Information

No publications provided

Study ID Numbers:	ONO-5920-02
Study First Received:	September 13, 2005
Last Updated:	September 14, 2006
ClinicalTrials.gov Identifier:	NCT00212667 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharma:

ONO-5920, osteoporosis, bisphosphonate

Study placed in the following topic categories:

Diphosphonates
Musculoskeletal Diseases
Osteoporosis, Postmenopausal

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on May 07, 2009