Status:

COMPLETED

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

Lead Sponsor:

Ono Pharmaceutical Co. Ltd

Collaborating Sponsors:

Astellas Pharma Inc

Conditions:

Involutional Osteoporosis

Eligibility:

FEMALE

55-80 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

444 Patients enrolled

Trial Details

Trial ID

NCT00212628

Start Date

June 1 2004

Last Update

June 14 2012

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Chugoku Region Facility

Chugoku, Japan

2

Chubu Region Facility

Chūbu, Japan

3

Hokkaido Region Facility

Hokkaido, Japan

4

Hokuriku Region Facility

Hokuriku, Japan

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