Osteoporosis
Conditions
Keywords
osteoporosis, ibandronate
Brief summary
This is an open label, multi-centre, non-interventional post-marketing surveillance.
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.
Interventions
DRUGIbandronate
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.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of adverse event after ibandronate administration | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| The number of unexpected adverse events after ibandronate administration | 6 months |
| The number of serious adverse events after ibandronate administration | 6 months |
Countries
South Korea
Outcome results
None listed