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

Study Overview
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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 injection administered in postmenopausal osteoporosis patients according to the prescribing information

Official Title
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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

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: BONVIVA(ibandronate) injection


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BONVIVA(ibandronate)<br>Patients administrated ibandronate injection with postmenopausal osteoporosis | Drug: BONVIVA(ibandronate) injection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse event after ibandronate administration |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, ibandronate