Last updated: 11/03/2018 12:59:14

Osteoporosis: GPRD study - An assessment of GI associated adverse events associated with bisphophonates in the UK

GSK study ID
112437
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Osteoporosis: GPRD study - An assessment of GI associated adverse events associated with bisphophonates in the UK
Trial description: To determine the incidence of bisphosphonates-associated GI adverse events among different marketed bisphosphonates in post-menopausal women in the UK
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

GI adverse events

Timeframe: 1 year

Secondary outcomes:
Not applicable
Interventions:
  • Drug: bisphosphonates
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Osteoporosis
    Product
    ibandronic acid
    Collaborators
    Not applicable
    Study date(s)
    March 2009 to September 2011
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    50+ years
    Accepts healthy volunteers
    none
    • Post-menopausal women over 50 years taking daily, weekly or monthly bisphosphonates or non-bisphosphonates
    • Have Pagets disease of the bone or a malignant cancer
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Post-menopausal women over 50 years taking daily, weekly or monthly bisphosphonates or non-bisphosphonates
    Exclusion criteria:
    • Have Pagets disease of the bone or a malignant cancer

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2011-30-09

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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