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

Primary Purpose

Involutional Osteoporosis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

ONO-5920

About this trial

This is an interventional treatment trial for Involutional Osteoporosis focused on measuring ONO-5920, osteoporosis, bisphosphonate

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

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

Full Information

NCT ID

NCT00212719

First Posted

September 13, 2005

Last Updated

October 10, 2012

Sponsor

Ono Pharmaceutical Co. Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00212719

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ono Pharmaceutical Co. Ltd

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Involutional Osteoporosis

Keywords

ONO-5920, osteoporosis, bisphosphonate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

250 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ONO-5920

Primary Outcome Measure Information:

Title

Mean bone mineral density of the lumbar spine (L2-4 BMD)

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Project Leader, ' Development Planning

Organizational Affiliation

Ono Pharmaceutical Co. Ltd

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

19264155

Citation

Hagino H, Nishizawa Y, Sone T, Morii H, Taketani Y, Nakamura T, Itabashi A, Mizunuma H, Ohashi Y, Shiraki M, Minamide T, Matsumoto T. A double-blinded head-to-head trial of minodronate and alendronate in women with postmenopausal osteoporosis. Bone. 2009 Jun;44(6):1078-84. doi: 10.1016/j.bone.2009.02.016. Epub 2009 Mar 2.

Results Reference

derived

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

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