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

An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety of BONVIVA(Ibandronate) Injection Administered in Korean Patients According to the Prescribing Information

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01376102

Acronym

BONINJPMS

Enrollment

657

Registered

2011-06-20

Start date

2007-11-30

Completion date

2013-02-28

Last updated

2014-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

osteoporosis, ibandronate

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

Interventions

DRUGBONVIVA(ibandronate) injection

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.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The number of adverse event after ibandronate administration	6 months

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026