Skip to main content
OpenTrials
Completed

NCT Number: NCT01376102

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

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

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site

Seoul, 120-752, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BONVIVA(ibandronate) injection

Drug

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.

Primary outcomes

  1. The number of adverse event after ibandronate administration

    Time frame: 6 months

Secondary outcomes

  1. The number of unexpected adverse drug reaction after BONVIVA(ibandronate) injection administration

    Time frame: 6 months

  2. The number of serious adverse event after BONVIVA(ibandronate) injection administration

    Time frame: 6 months

  3. Effectiveness of BONVIVA(ibandronate) injection treatment

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Acronym: BONINJPMS

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jun 20, 2011
Registry last updated
Jun 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.