Last updated: 11/07/2018 03:21:27
BONVIVA(Ibandronate) injection PMS(post-marketing surveillance)BONINJPMS
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official 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
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 drug reaction after BONVIVA(ibandronate) injection administration
Timeframe: 6 months
The number of serious adverse event after BONVIVA(ibandronate) injection administration
Timeframe: 6 months
Effectiveness of BONVIVA(ibandronate) injection treatment
Timeframe: 6 months
Interventions:
Enrollment:
657
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Ji-Young Bae, Han-Kyu Lee, Yil-Seob Lee. A Post-marketing Surveillance to Evaluate the Safety of Ibandronate Injection in Korean Women with Postmenopausal Osteoporosis. JPERM. 2016,8:24-28
Medical condition
Osteoporosis
Product
ibandronic acid
Collaborators
Not applicable
Study date(s)
November 2007 to November 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
Not applicable
Accepts healthy volunteers
No
- All subjects must satisfy the following criteria at study entry:
- Subjects administered with BONVIVA(ibandronate) injection following the locally approved prescribing information
- 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.
Inclusion and exclusion criteria
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.
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2012-22-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website