Last updated: 11/03/2018 11:06:20
BONVIVA(ibandronate) PMS(post-marketing surveillance )BONPMS
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: 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
Trial description: This is an open label, multi-centre, non-interventional post-marketing surveillance.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of adverse event after ibandronate administration
Timeframe: 6 months
Secondary outcomes:
The number of unexpected adverse events after ibandronate administration
Timeframe: 6 months
The number of serious adverse events after ibandronate administration
Timeframe: 6 months
Interventions:
Drug: Ibandronate
Enrollment:
659
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Osteoporosis
Product
ibandronic acid
Collaborators
Not applicable
Study date(s)
June 2007 to March 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
Not applicable+ years
Accepts healthy volunteers
No
- All subjects must satisfy the following criteria at study entry:
- 1)Subjects diagnosed with osteoporosis in postmenopausal women.
- 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.
Inclusion and exclusion criteria
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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2012-07-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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