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Fracture Risk With Thiazolidinediones

2014-08-27 03:16:27 | BioPortfolio

Summary

Treatment with thiazolidinediones has recently been reported to possibly increase the risk of fractures in a randomized trial exploring the efficacy of rosiglitazone, 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.

Description

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 ICD-9 code for type 2 diabetes and have 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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Conditions

Type II Diabetes

Intervention

TZD + spironolactone, TZD + amiloride, TZD only (RSG or PIO or troglitazone)

Status

Active, not recruiting

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:27-0400

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