BONVIVA(Ibandronate) PMS(Post-marketing Surveillance ) | NCT01381393

Studies
BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )

NCT01381393

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Nov 30, 2012Estimated

Enrollment

659Actual

Phase

Not provided

Conditions

Osteoporosis

Interventions

Ibandronate

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Jun 23, 2011

First Submission Date that Met QC Criteria

Jun 23, 2011

First Posted Date

Jun 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 28, 2012

Last Update Posted Date

Nov 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

659Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ibandronate		The subjects with osteoporosis in postmenopausal women	Drug: Ibandronate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ibandronate	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of adverse event after ibandronate administration		6 months

Secondary Outcomes

Measure	Description	Time Frame
The number of unexpected adverse events after ibandronate administration		6 months
The number of serious adverse events after ibandronate administration		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All subjects must satisfy the following criteria at study entry:

Subjects diagnosed with osteoporosis in postmenopausal women.
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.
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:

Patients with known hypersensitivity to ibandronate or to any of its excipients
Uncorrected hypocalcemia
Inability to stand or sit upright for at least 60 minutes

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients administrated ibandronate with postmenopausal osteoporosis in Korea

Sampling Method

Probability Sample

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals