BONVIVA(Ibandronate) PMS(Post-marketing Surveillance ) (BONPMS)
This study has been completed.
Information provided by (Responsible Party):
First received: June 23, 2011
Last updated: November 28, 2012
Last verified: November 2012
This is an open label, multi-centre, non-interventional post-marketing surveillance.
||Observational Model: Cohort
Time Perspective: Prospective
||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
Primary Outcome Measures:
- The number of adverse event after ibandronate administration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The number of unexpected adverse events after ibandronate administration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- The number of serious adverse events after ibandronate administration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2012 (Final data collection date for primary outcome measure)
The subjects with osteoporosis in postmenopausal women
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 Name: BONVIVA
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients administrated ibandronate with postmenopausal osteoporosis in Korea
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
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:
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381393
|GSK Investigational Site
|Seoul, Korea, Republic of, 137-701 |
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 23, 2011
||November 28, 2012
||Korea: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Bone Diseases, Metabolic
Bone Density Conservation Agents
Physiological Effects of Drugs