Clinical trial NCT01376102: BONVIVA(Ibandronate) Injection PMS(Post-marketing Surveillance)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: osteoporosis
ibandronate
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 657
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients administrated BONVIVA(ibandronate) injection with postmenopausal osteoporosis

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 injection administered in postmenopausal osteoporosis patients according to the prescribing information

Eligibility 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.

Primary outcomes:
measure: The number of adverse event after ibandronate administration
timeFrame: 6 months
Secondary outcomes:
measure: The number of unexpected adverse drug reaction after BONVIVA(ibandronate) injection administration
timeFrame: 6 months
measure: The number of serious adverse event after BONVIVA(ibandronate) injection administration
timeFrame: 6 months
measure: Effectiveness of BONVIVA(ibandronate) injection treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: