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

November 28, 2012 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

659

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients administrated ibandronate with postmenopausal osteoporosis in Korea

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ibandronate
The subjects with osteoporosis in postmenopausal women
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.
Other Names:
  • BONVIVA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of adverse event after ibandronate administration
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of unexpected adverse events after ibandronate administration
Time Frame: 6 months
6 months
The number of serious adverse events after ibandronate administration
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

November 30, 2012

Last Update Submitted That Met QC Criteria

November 28, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110603

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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