An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety of BONVIVA(Ibandronate) Administered in Korean Patients According to the Prescribing Information

GlaxoSmithKline1 site in 1 country659 target enrollmentJune 2007

ConditionsOsteoporosis

InterventionsIbandronate

DrugsIbandronate

Overview

Phase: Not Applicable
Intervention: Ibandronate
Conditions: Osteoporosis
Sponsor: GlaxoSmithKline
Enrollment: 659
Locations: 1
Primary Endpoint: The number of adverse event after ibandronate administration
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

March 2012

Last Updated

13 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•All subjects must satisfy the following criteria at study entry:
•Subjects diagnosed with osteoporosis in postmenopausal women.
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol
•Subjects with no experience of treatment using ibandronate.
•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:
•Patients with known hypersensitivity to ibandronate or to any of its excipients
•Uncorrected hypocalcemia
•Inability to stand or sit upright for at least 60 minutes

Arms & Interventions

Ibandronate

The subjects with osteoporosis in postmenopausal women

Intervention: Ibandronate

Outcomes

Primary Outcomes

The number of adverse event after ibandronate administration

Time Frame: 6 months

Secondary Outcomes

The number of unexpected adverse events after ibandronate administration(6 months)
The number of serious adverse events after ibandronate administration(6 months)