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

NCT ID: NCT00212628

Last Updated: 2012-06-14

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Involutional Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Minodronic acid hydrate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients who was included in study ONO-5920-02 and completed the medication for two years

Exclusion Criteria

1. Patients judged to be unsuitable by safety evaluation as clinical trial subjects by the investigator
2. Patients having secondary osteoporosis or another condition that presents low bone mass
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Astellas Pharma Inc

INDUSTRY

Sponsor Role collaborator

Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Project Leader, Development Planning

Role: STUDY_DIRECTOR

Ono Pharmaceutical Co. Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chugoku Region Facility

Chugoku, , Japan

Site Status

Chubu Region Facility

Chūbu, , Japan

Site Status

Hokkaido Region Facility

Hokkaido, , Japan

Site Status

Hokuriku Region Facility

Hokuriku, , Japan

Site Status

Kanto Region Facility

Kanto, , Japan

Site Status

Kinki Region Facility

Kinki, , Japan

Site Status

Kyushu Region Facility

Kyushu, , Japan

Site Status

Shikoku Region Facility

Shikoku Region Facility, , Japan

Site Status

Tohoku Region Facility

Tōhoku, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ONO-5920-04

Identifier Type: -

Identifier Source: org_study_id

NCT00189865

Identifier Type: -

Identifier Source: nct_alias

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Denosumab China Phase III Study
NCT02014467 COMPLETED PHASE3
Network Osteoporosis Study
NCT00209469 UNKNOWN PHASE2/PHASE3