Fracture Risk With Thiazolidinediones

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Description

TZD 6-month Cohort (Including TZD 12-month Cohort)

The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (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 of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.

Participant Flow:   Overall Study

	TZD 6-month Cohort (Including TZD 12-month Cohort)
STARTED	98483
COMPLETED	98483
NOT COMPLETED	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

Description

TZD 6-month Cohort (Including TZD 12-month Cohort)

The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (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 of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.

Baseline Measures

	TZD 6-month Cohort (Including TZD 12-month Cohort)
Overall Participants Analyzed  [Units: Participants]	98483
Age  [Units: Years] Mean (Standard Deviation)	52.2  (8.33)
Sex: Female, Male  [Units: Participants] Count of Participants
Female	37738  38.3%
Male	60745  61.7%

1.  Primary:

Number of Low Impact Fractures in Males and Females After 6 Months of Exposure to TZD   [ Time Frame: 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 ]

2.  Primary:

Number of Low Impact Fractures in Males and Females After 12 Months of Exposure to TZD   [ Time Frame: 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 ]

3.  Secondary:

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

4.  Secondary:

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

5.  Secondary:

Number of Hip Fractures Combined in Males and Females After 6 Months of Exposure to TZD   [ Time Frame: 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 ]

6.  Secondary:

Number of Hip Fractures Combined in Males and Females After 12 Months of Exposure to TZD   [ Time Frame: 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 ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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