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Completed

NCT Number: NCT01381393

BONVIVA(Ibandronate) PMS(Post-marketing Surveillance )

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

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Observational

Primary location

GSK Investigational Site

Seoul, 137-701, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: BONVIVA

Primary outcomes

  1. The number of adverse event after ibandronate administration

    Time frame: 6 months

Secondary outcomes

  1. The number of unexpected adverse events after ibandronate administration

    Time frame: 6 months

  2. The number of serious adverse events after ibandronate administration

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Acronym: BONPMS

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2011
Registry last updated
Nov 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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