GSK Investigational Site
Seoul, 120-752, South Korea
NCT Number: NCT01376102
This is an open label, multi-centre, non-interventional post-marketing surveillance
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Observational
Seoul, 120-752, South Korea
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
Time frame: 6 months
GlaxoSmithKline
Industry
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
Acronym: BONINJPMS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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