BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )

Osteoporosis Clinical Trial

— BONPMS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01381393
• Other study ID #: 110603
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: November 28, 2012
• Start date: June 2007
• Est. completion date: March 2012

Study information

• Verified date: November 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 659
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Ibandronate
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.

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of adverse event after ibandronate administration		6 months	No
Secondary	The number of unexpected adverse events after ibandronate administration		6 months	No
Secondary	The number of serious adverse events after ibandronate administration		6 months	No