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BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Ibandronate (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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 administration

The 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

GSK Investigational Site, Seoul 137-701, Korea, Republic of
Additional Information

Starting date: June 2007
Last updated: November 28, 2012

Page last updated: August 23, 2015

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