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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01381393
First received: June 23, 2011
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  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:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse event after ibandronate administration [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of unexpected adverse events after ibandronate administration [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The number of serious adverse events after ibandronate administration [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01381393     History of Changes
Other Study ID Numbers: 110603
Study First Received: June 23, 2011
Last Updated: November 28, 2012
Health Authority: Korea: Food and Drug Administration

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013