BONVIVA(Ibandronate) Injection PMS(Post-marketing Surveillance) (BONINJPMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01376102
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : June 16, 2014
Information provided by (Responsible Party):

Brief Summary:
This is an open label, multi-centre, non-interventional post-marketing surveillance

Condition or disease Intervention/treatment
Osteoporosis Drug: BONVIVA(ibandronate) injection

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

Study Type : Observational
Actual Enrollment : 657 participants
Time Perspective: Prospective
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 Start Date : November 2007
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Group/Cohort Intervention/treatment
Patients administrated ibandronate injection with postmenopausal osteoporosis
Drug: BONVIVA(ibandronate) injection
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.

Primary Outcome Measures :
  1. The number of adverse event after ibandronate administration [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The number of unexpected adverse drug reaction after BONVIVA(ibandronate) injection administration [ Time Frame: 6 months ]
  2. The number of serious adverse event after BONVIVA(ibandronate) injection administration [ Time Frame: 6 months ]
  3. Effectiveness of BONVIVA(ibandronate) injection treatment [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients administrated BONVIVA(ibandronate) injection with postmenopausal osteoporosis

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01376102

Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT01376102     History of Changes
Other Study ID Numbers: 111412
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014

Keywords provided by GlaxoSmithKline:

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Ibandronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs