Last updated: 11/03/2018 14:51:41

Fracture risk with thiazolidinediones

GSK study ID
113332
See study documents
Clinicaltrials.gov ID
NCT01055223
See results summary
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: The association between exposure to spironolactone or amiloride and fracture risk among subjects treated with thiazolidinediones
Trial description: Treatment with thiazolidinediones (TZD) has recently been reported to possibly increase the risk of fractures in a randomized trial exploring the efficacy of rosiglitazone (RSG), metformin, or glyburide encompassing 4360 patients with type 2 diabetes.
It is hypothesized that spironolactone, a diuretic that is broadly used for the treatment of fluid retention and edema associated with TZD, has a potential protective effect against bone fractures. However, to our knowledge, this has not been tested in diabetic patients treated with TZD. Amiloride is another diuretic that shares with spironolactone the anti mineralocorticoid ion gated channels activity and will be analysed in this study with regard to possible protective effect against bone fracture in combination with TZD.
This study is a nested case-control study conducted among type 2 diabetes subjects exposed to TZD. The study aims to explore if the risk of fracture is reduced among type 2 diabetic subjects exposed to spironolactone and TZD. The study will compare the odds of any low impact fracture, and hand, foot, upper arm, wrist, and hip fracture incidence in subjects treated with TZD+spironolactone and TZD+amiloride compared to subjects treated with TZD only.
The study population will consist of type 2 diabetes patients aged 18 -65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months or at least 12 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO] or troglitazone) during their follow-up time available in the database.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of low impact fractures in males and females after 6 months of exposure to TZD

Timeframe: From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 and December 31, 2008

Number of low impact fractures in males and females after 12 months of exposure to TZD

Timeframe: From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008

Secondary outcomes:

Number of fractures of the hand, foot, upper arm, and wrist in males and females after 6 months of exposure to TZD

Timeframe: From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008

Number of fractures of the hand, foot, upper arm, and wrist in males and females after 12 months of exposure to TZD

Timeframe: From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008

Number of hip fractures combined in males and females after 6 months of exposure to TZD

Timeframe: From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008

Number of hip fractures combined in males and females after 12 months of exposure to TZD

Timeframe: From the earliest date of first TZD prescription to the fracture diagnosis date (Cases) or the end of follow-up in the database (Controls) between January 1, 1997 to December 31, 2008

Interventions:
  • Drug: TZD only (RSG or PIO or troglitazone)
  • Drug: TZD + spironolactone
  • Drug: TZD + amiloride
    • Enrollment:
    98483
    Primary completion date:
    2010-31-03
    Observational study model:
    Case-Control
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Fractures, Bone, Type II diabetes
    Product
    rosiglitazone
    Collaborators
    Not applicable
    Study date(s)
    May 2009 to March 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • At least one ICD-9 code for type 2 diabetes
    • At least 6 months or at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database (The subject’s study period begin date will be defined as the earliest date of their first TZD prescription. Subjects included in the study are required to have at least six months of follow-up time in the database prior to their first TZD prescription)
    • Subjects with a diagnosis of Paget’s disease and osteomalacia
    • A history of fracture, osteoporosis or cancer prior to the first prescription of TZD (study begin date)
    Inclusion and exclusion criteria
    Inclusion criteria:
    • At least one ICD-9 code for type 2 diabetes -At least 6 months or at least 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database (The subject’s study period begin date will be defined as the earliest date of their first TZD prescription. Subjects included in the study are required to have at least six months of follow-up time in the database prior to their first TZD prescription)
    Exclusion criteria:
    • Subjects with a diagnosis of Paget’s disease and osteomalacia
    • A history of fracture, osteoporosis or cancer prior to the first prescription of TZD (study begin date)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2010-31-03
    Actual study completion date
    2010-31-03

    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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