Overview
BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )
Status:
Completed
Completed
Trial end date:
2012-03-01
2012-03-01
Target enrollment:
0
0
Participant gender:
Female
Female
Summary
This is an open label, multi-centre, non-interventional post-marketing surveillance.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
GlaxoSmithKlineTreatments:
Diphosphonates
Ibandronic Acid
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