NCT00212667

CompletedPhase 3

Controlled Study of ONO-5920 in Patients With Involutional O...

Ono Pharmaceutical Co., Ltd.Source

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Other study identifiers

Sponsor study identifier

ONO-5920-02

Study Type

interventional

Reported enrollment (type unavailable)

650

Locations

0 countries

Sites

N/A

Timeline

Study Start

August 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2006

Actual (reported)

Study Completion

Not reported

Date not reported

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 650 participants
Study completion date: Not reported
Date not reported
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 13, 2005
Actual (reported)
First Posted
September 21, 2005
Actual (reported)
Primary Completion
September 2006
Actual (reported)

Last Updated: October 11, 2012
Status Verified: October 2012
Last Update Submitted: October 10, 2012

Conditions

Involutional Osteoporosis

Keywords

ONO-5920, osteoporosis, bisphosphonate

Outcome Measures

Primary Outcomes (1)

New fragility vertebral fracture

Secondary Outcomes (1)

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

Interventions

ONO-5920Drug

Eligibility Criteria

Age55 Years - 80 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients with fragility fracture according to the diagnostic criterial for the diagnosis of Primary Osteoporosis
Patients having radiographically confirmed vertebral (T4-L4) fractures

Sponsors & Collaborators

Astellas Pharma Inc
Industrycollaborator
Ono Pharmaceutical Co., Ltd.
Industrylead

Related Publications (1)

Matsumoto T, Hagino H, Shiraki M, Fukunaga M, Nakano T, Takaoka K, Morii H, Ohashi Y, Nakamura T. Effect of daily oral minodronate on vertebral fractures in Japanese postmenopausal women with established osteoporosis: a randomized placebo-controlled double-blind study. Osteoporos Int. 2009 Aug;20(8):1429-37. doi: 10.1007/s00198-008-0816-7. Epub 2008 Dec 20.
PMID: 19101754DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

YM 529

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

Project Leader, Development Planning
Ono Pharmaceutical Co. LtTd.
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

August 2002

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2006

Actual (reported)

You may not qualify if:

Patients having secondary osteoporosis or another condition that presents low bone mass
Patients having findings on X-ray that affect evaluation of vertebral fracture
Patients that have been administered bisphosphonate derivatives

Contact the study team to confirm eligibility.

Last Updated

October 11, 2012

Record last verified: 2012-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00212667
Data provider: ClinicalTrials.gov
Source updated: 2012-10-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:34:42 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record