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

GlaxoSmithKline1 site in 1 country657 target enrollmentNovember 2007

ConditionsOsteoporosis

InterventionsBONVIVA(ibandronate) injection

DrugsBONVIVA(ibandronate) injection

Overview

Phase: Not Applicable
Intervention: BONVIVA(ibandronate) injection
Conditions: Osteoporosis
Sponsor: GlaxoSmithKline
Enrollment: 657
Locations: 1
Primary Endpoint: The number of adverse event after ibandronate administration
Status: Completed
Last Updated: 11 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 injection administered in postmenopausal osteoporosis patients according to the prescribing information

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

February 2013

Last Updated

11 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 administered with BONVIVA(ibandronate) injection following the locally approved prescribing information Women diagnosed with postmenopausal osteoporosis. 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 injection Note: Subjects, who have experience of other bisphosphonates treatment, can be included.
•Subjects who are indicated and administered of ibandronate injection according to the Prescribing Information in normal prescription use

Exclusion Criteria

•Considering the nature of this non-interventional PMS, there is no strict exclusion criteria set up. The doctors participating this study to enrol the subjects prescribed with ibandronate injection 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 injection should not be administered to the following patients:
•Patients with known hypersensitivity to ibandronate injection or to any of its excipients Uncorrected hypocalcemia Note: Ibandronate injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients.

Arms & Interventions

BONVIVA(ibandronate)

Patients administrated ibandronate injection with postmenopausal osteoporosis

Intervention: BONVIVA(ibandronate) injection

Outcomes

Primary Outcomes

The number of adverse event after ibandronate administration

Time Frame: 6 months

Secondary Outcomes

The number of unexpected adverse drug reaction after BONVIVA(ibandronate) injection administration(6 months)
The number of serious adverse event after BONVIVA(ibandronate) injection administration(6 months)
Effectiveness of BONVIVA(ibandronate) injection treatment(6 months)