BONVIVA(Ibandronate) Injection PMS(Post-marketing Surveillance)

Completed

• Conditions: Osteoporosis
• Interventions: Drug: BONVIVA(ibandronate) injection

• Registration Number: NCT01376102
• 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 injection administered in postmenopausal osteoporosis patients according to the prescribing information

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-20
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-12
• Last Update Posted: 2014-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 657

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BONVIVA(ibandronate)	BONVIVA(ibandronate) injection	Patients administrated ibandronate injection with postmenopausal osteoporosis

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 drug reaction after BONVIVA(ibandronate) injection administration	6 months
The number of serious adverse event after BONVIVA(ibandronate) injection administration	6 months
Effectiveness of BONVIVA(ibandronate) injection treatment	6 months

Trial Locations

Locations (1)

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