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BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )

NCT ID: NCT01381393

Last Updated: 2012-11-30

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

Total Enrollment

659 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-03-31

Brief Summary

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This is an open label, multi-centre, non-interventional post-marketing surveillance.

Detailed Description

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This is an open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety of ibandronate administered in Korean patients according to the prescribing information.

Conditions

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Osteoporosis

Keywords

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osteoporosis ibandronate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ibandronate

The subjects with osteoporosis in postmenopausal women

Ibandronate

Intervention Type DRUG

Basically there is no treatment allocation. Subjects who would be administered of ibandronate at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Interventions

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Ibandronate

Basically there is no treatment allocation. Subjects who would be administered of ibandronate at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

Intervention Type DRUG

Other Intervention Names

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BONVIVA

Eligibility Criteria

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Inclusion Criteria

All subjects must satisfy the following criteria at study entry:

1. Subjects diagnosed with osteoporosis in postmenopausal women.
2. Subjects who the investigator believes that they can and will comply with the requirements of the protocol
3. Subjects with no experience of treatment using ibandronate.
4. Subjects who are administered of ibandronate in normal prescription use

Exclusion Criteria

The following criteria should be checked at the time of study entry.

According to contraindication on the prescribing information, ibandronate should not be administered to the following patients:

1. Patients with known hypersensitivity to ibandronate or to any of its excipients
2. Uncorrected hypocalcemia
3. Inability to stand or sit upright for at least 60 minutes
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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110603

Identifier Type: -

Identifier Source: org_study_id