ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

April 30, 2015 updated by: Astellas Pharma Inc

A Multi-center Double-blind Parallel-group Comparison Study in Involutional Osteoporosis Patients to Examine the Efficacy and Safety of ONO-5920/YM529 Monthly Intermittent Formulation With Its Daily Formulation.

This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

692

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Kyusyu, Japan
      • Shikoku, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients whose bone mineral density is <70% of Young Adult Mean (YAM), or <80% of YAM who have fragile fracture history
  • Patients can walk on his/her own
  • Written informed consent has been obtained from the patient.

Exclusion Criteria:

  • Sequential osteoporosis patients or patients with other disorders showing low bone mass
  • Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method
  • Patients who are unable to keep raising or standing for ≥30 min
  • Patients with peptic ulcer
  • Patients who have experienced anamnesis or gastrectomy (total extraction)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. Monthly - Dose 1
Monthly intermittent administration, dose 1
Drug: YM529 / ONO-5920
Oral
Other Names:
  • YM529
  • ONO-5920
  • Minodronic acid
Experimental: 2. Monthly - Dose 2
Monthly intermittent administration, dose 2
Drug: YM529 / ONO-5920
Oral
Other Names:
  • YM529
  • ONO-5920
  • Minodronic acid
Active Comparator: 3. Daily
Daily administration
Drug: YM529 / ONO-5920
Oral
Other Names:
  • YM529
  • ONO-5920
  • Minodronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent changes in the lumbar vertebral bone mineral density (L2-4BMD) by the DXA method
Time Frame: At the final evaluation point
At the final evaluation point

Secondary Outcome Measures

Outcome Measure
Time Frame
Time-course changes in the percent change of bone metabolism markers
Time Frame: Through the treatment period
Through the treatment period
Time-course changes in the total femoral bone mineral density by the DXA method
Time Frame: Through the treatment period
Through the treatment period
Assessment of adverse events, lab test values
Time Frame: Through the treatment period
Through the treatment period
Frequency of fracture
Time Frame: At the final evaluation point
At the final evaluation point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Toshiomi Minamide, Ono Pharmaceutical Co. Ltd
  • Study Chair: Central Contact, Clinical Development Administration Dept., Astellas Pharma Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 18, 2008

First Submitted That Met QC Criteria

November 18, 2008

First Posted (Estimate)

November 20, 2008

Study Record Updates

Last Update Posted (Estimate)

May 4, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 529-CL-028
  • ONO-5920-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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