BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: Ibandronate (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
Summary
This is an open label, multi-centre, non-interventional post-marketing surveillance.
Clinical Details
Official title: 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
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: The number of adverse event after ibandronate administration
Secondary outcome: The number of unexpected adverse events after ibandronate administrationThe number of serious adverse events after ibandronate administration
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
All subjects must satisfy the following criteria at study entry:
1. Subjects diagnosed with osteoporosis in postmenopausal women.
2. Subjects who the investigator believes that they can and will comply with the
requirements of the protocol
3. Subjects with no experience of treatment using ibandronate.
4. 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:
1. Patients with known hypersensitivity to ibandronate or to any of its excipients
2. Uncorrected hypocalcemia
3. Inability to stand or sit upright for at least 60 minutes
Locations and Contacts
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Seoul 137-701, Korea, Republic of; Recruiting
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44 (0) 20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
Additional Information
Starting date: June 2007
Last updated: June 30, 2011
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