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

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

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

Exclusion Criteria

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

Minimum Eligible Age

55 Years

Maximum Eligible Age

80 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. LtTd.

References

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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.

Reference Type DERIVED

PMID: 19101754 (View on PubMed)

Other Identifiers

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ONO-5920-02

Identifier Type: -

Identifier Source: org_study_id

NCT00189891