BONVIVA(Ibandronate) PMS(Post-marketing Surveillance ) (BONPMS)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Osteoporosis

Treatments: Drug: Ibandronate

Study type: Observational

Funder types: Industry

Identifiers

NCT01381393

110603

Details and patient eligibility

About

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

Full description

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.

Enrollment: 659 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Considering the nature of this non-interventional PMS study, there is no strict exclusion criteria set up. The doctors participating this study to enrol the subjects prescribed with ibandronate following the locally approved Prescribing Information.

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

Trial design

659 participants in 1 patient group

Ibandronate

Description:

The subjects with osteoporosis in postmenopausal women

Treatment:

Drug: Ibandronate