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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Brief Summary

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

Detailed Description

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Conditions

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Involutional Osteoporosis

Keywords

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ONO-5920, osteoporosis, bisphosphonate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ONO-5920

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.

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.

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Project Leader, ' Development Planning

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

References

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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.

Reference Type DERIVED

PMID: 19264155 (View on PubMed)

Other Identifiers

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ONO-5920-03

Identifier Type: -

Identifier Source: org_study_id