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

This study has been completed.

First Received: September 13, 2005 Last Updated: April 5, 2006 History of Changes

Sponsored by:	Ono Pharma
Information provided by:	Ono Pharma
ClinicalTrials.gov Identifier:	NCT00212719

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: Minerals Osteoporosis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active 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:

Bone mineral density at femur, fragility fractures, biochemical markers of bone turnover, lower back pain

Estimated Enrollment:	250
Study Start Date:	May 2003

Eligibility

Criteria

Inclusion Criteria:

A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.
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 that affect measurement of lumbar spinal bone mineral density by DXA
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: NCT00212719

Sponsors and Collaborators

Ono Pharma

Investigators

Study Director:

Project Leader, ` Development Planning

Ono Pharma

More Information

No publications provided

Study ID Numbers:	ONO-5920-03
Study First Received:	September 13, 2005
Last Updated:	April 5, 2006
ClinicalTrials.gov Identifier:	NCT00212719 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