Fracture Risk With Thiazolidinediones - Study Results

Study Type:	Observational
Study Design:	Observational Model: Case Control; Time Perspective: Retrospective
Conditions:	Fractures, Bone Type II Diabetes
Interventions:	Drug: TZD only (RSG or PIO or troglitazone) Drug: TZD + spironolactone Drug: TZD + amiloride

Participant Flow

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.

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

Baseline Characteristics

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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.

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)
Number of Participants [units: participants]	98483
Age [units: Years] Mean ± Standard Deviation	52.2 ± 8.33
Gender [units: Participants]
Female	37738
Male	60745

Outcome Measures

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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 ]

Show Outcome Measure 1

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 ]

Show Outcome Measure 2

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 ]

Show Outcome Measure 3

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 ]

Show Outcome Measure 4

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 ]

Show Outcome Measure 5

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 ]

Show Outcome Measure 6

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT01055223 History of Changes
Other Study ID Numbers:	113332
Study First Received:	January 21, 2010
Results First Received:	December 16, 2010
Last Updated:	June 2, 2011
Health Authority:	United States: No Health Authority