BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Ibandronate

• Registration Number: NCT01381393
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is an open label, multi-centre, non-interventional post-marketing surveillance.

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-28
• Last Update Posted: 2012-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 659

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ibandronate	Ibandronate	The subjects with osteoporosis in postmenopausal women

Primary Outcome Measures

Name	Time	Method
The number of adverse event after ibandronate administration	6 months

Secondary Outcome Measures

Name	Time	Method
The number of unexpected adverse events after ibandronate administration	6 months
The number of serious adverse events after ibandronate administration	6 months

Trial Locations

Locations (1)

GSK Investigational Site; 🇰🇷 Seoul, Korea, Republic of