BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )
BONPMS
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
1 other identifier
observational
659
1 country
1
Brief Summary
This is an open label, multi-centre, non-interventional post-marketing surveillance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedNovember 30, 2012
November 1, 2012
4.8 years
June 23, 2011
November 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The number of adverse event after ibandronate administration
6 months
Secondary Outcomes (2)
The number of unexpected adverse events after ibandronate administration
6 months
The number of serious adverse events after ibandronate administration
6 months
Study Arms (1)
Ibandronate
The subjects with osteoporosis in postmenopausal women
Interventions
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.
Eligibility Criteria
Patients administrated ibandronate with postmenopausal osteoporosis in Korea
You may qualify if:
- All subjects must satisfy the following criteria at study entry:
- Subjects diagnosed with osteoporosis in postmenopausal women.
- 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.
- Subjects who are administered of ibandronate in normal prescription use
You may not qualify if:
- 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:
- Patients with known hypersensitivity to ibandronate or to any of its excipients
- Uncorrected hypocalcemia
- Inability to stand or sit upright for at least 60 minutes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Seoul, 137-701, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
June 1, 2007
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
November 30, 2012
Record last verified: 2012-11