BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )

Launched by GLAXOSMITHKLINE · Jun 23, 2011

Keywords

ClinConnect Summary

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.

Gender

FEMALE

Eligibility criteria

• 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