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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier:
NCT00212719
First received: September 13, 2005
Last updated: October 10, 2012
Last verified: October 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

Resource links provided by NLM:


Further study details as provided by Ono Pharmaceutical Co. Ltd:

Primary Outcome Measures:
  • Mean bone mineral density of the lumbar spine (L2-4 BMD)

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
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.
  2. Other inclusion criteria as specified in the study protocol.

Exclusion Criteria:

  1. Patients having secondary osteoporosis or another condition that presents low bone mass.
  2. Patients having findings that affect measurement of lumbar spinal bone mineral density by DXA
  3. Patients that have been administered bisphosphonate derivatives.
  4. Other exclusion criteria as specified in the study protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212719

Sponsors and Collaborators
Ono Pharmaceutical Co. Ltd
Investigators
Study Director: Project Leader, ` Development Planning Ono Pharmaceutical Co. Ltd
  More Information

No publications provided by Ono Pharmaceutical Co. Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov Identifier: NCT00212719     History of Changes
Other Study ID Numbers: ONO-5920-03
Study First Received: September 13, 2005
Last Updated: October 10, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ono Pharmaceutical Co. Ltd:
ONO-5920, osteoporosis, bisphosphonate

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 23, 2014