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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01381393
First Posted: June 27, 2011
Last Update Posted: November 30, 2012
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This is an open label, multi-centre, non-interventional post-marketing surveillance.

Condition Intervention
Osteoporosis Drug: Ibandronate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety of BONVIVA(Ibandronate) Administered in Korean Patients According to the Prescribing Information

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • The number of unexpected adverse events after ibandronate administration [ Time Frame: 6 months ]
  • The number of serious adverse events after ibandronate administration [ Time Frame: 6 months ]

Enrollment: 659
Study Start Date: June 2007
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ibandronate
The subjects with osteoporosis in postmenopausal women
Drug: Ibandronate
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.
Other Name: BONVIVA

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients administrated ibandronate with postmenopausal osteoporosis in Korea
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01381393


Locations
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381393     History of Changes
Other Study ID Numbers: 110603
First Submitted: June 23, 2011
First Posted: June 27, 2011
Last Update Posted: November 30, 2012
Last Verified: November 2012

Keywords provided by GlaxoSmithKline:
osteoporosis
ibandronate

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