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This is an open label, multi-centre, non-interventional post-marketing surveillance
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BONVIVA(ibandronate) | Patients administrated ibandronate injection with postmenopausal osteoporosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BONVIVA(ibandronate) injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The number of adverse event after ibandronate administration | 6 months |
| 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 |
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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.
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Patients administrated BONVIVA(ibandronate) injection with postmenopausal osteoporosis
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Effectiveness of BONVIVA(ibandronate) injection treatment | 6 months |
| D009750 |
| Nutritional and Metabolic Diseases |