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:

NCT00212628

First received: September 13, 2005

Last updated: June 12, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

June 12, 2012

Start Date ^ICMJE

June 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

New fragility vertebral fracture

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00212628 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

New clinical fracture, biochemical markers of bone turnover, height, mean bone mineral density of the lumbar spine (L2-4 BMD), lower back pain.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Involutional Osteoporosis

Intervention ^ICMJE

Drug: Minodronic acid hydrate

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

444

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients who was included in study ONO-5920-02 and completed the medication for two years
Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator
Patients having secondary osteoporosis or another condition that presents low bone mass
Other exclusion criteria as specified in the study protocol

Gender

Female

Ages

55 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT00212628

Other Study ID Numbers ^ICMJE

ONO-5920-04

Has Data Monitoring Committee

Not Provided

Responsible Party

Ono Pharmaceutical Co. Ltd

Study Sponsor ^ICMJE

Ono Pharmaceutical Co. Ltd

Collaborators ^ICMJE

Astellas Pharma Inc

Investigators ^ICMJE

Study Director:

Project Leader, Development Planning

Ono Pharmaceutical Co. Ltd

Information Provided By

Ono Pharmaceutical Co. Ltd

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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