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Fracture Risk With Thiazolidinediones

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fractures, Bone; Type II Diabetes

Intervention: TZD only (RSG or PIO or troglitazone) (Drug); TZD + spironolactone (Drug); TZD + amiloride (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: The Association Between Exposure to Spironolactone or Amiloride and Fracture Risk Among Subjects Treated With Thiazolidinediones

Study design: Observational Model: Case Control, Time Perspective: Retrospective

Primary outcome:

Number of Low Impact Fractures in Males and Females After 6 Months of Exposure to TZD

Number of Low Impact Fractures in Males and Females After 12 Months of Exposure to TZD

Secondary outcome:

Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 6 Months of Exposure to TZD

Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 12 Months of Exposure to TZD

Number of Hip Fractures Combined in Males and Females After 6 Months of Exposure to TZD

Number of Hip Fractures Combined in Males and Females After 12 Months of Exposure to TZD

Detailed description: Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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)

Locations and Contacts

Additional Information

Starting date: May 2009
Last updated: June 2, 2011

Page last updated: August 23, 2015

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