DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: BONVIVA(ibandronate) injection (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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

Clinical Details

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 design: Time Perspective: Prospective

Primary outcome: The number of adverse event after ibandronate administration

Secondary outcome:

The number of unexpected adverse drug reaction after BONVIVA(ibandronate) injection administration

The number of serious adverse event after BONVIVA(ibandronate) injection administration

Effectiveness of BONVIVA(ibandronate) injection treatment

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

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 ╬╝mol/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.

Locations and Contacts

GSK Investigational Site, Seoul 120-752, Korea, Republic of
Additional Information

Starting date: November 2007
Last updated: June 12, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017