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Fracture Risk With Thiazolidinediones

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01055223
First received: January 21, 2010
Last updated: June 2, 2011
Last verified: June 2011
History of Changes
Results First Received: December 16, 2010  
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
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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
No text entered.

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  



  Baseline Characteristics
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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)  
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
  Show All Outcome Measures

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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Time Frame No text entered.
Additional Description This is a retrospective study of pre-existing medical record and/or health insurance claims data; all data are de-identified, and thus no assessments of Serious or Non-serious Adverse Events are possible.

Reporting Groups
  Description
TZD 6-month Cohort The study population consisted of type 2 diabetes patients 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 of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.
TZD-12 Month Cohort The study population consisted of type 2 diabetes patients 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 12 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.

Serious Adverse Events
    TZD 6-month Cohort     TZD-12 Month Cohort  
Total, serious adverse events      
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)  




  Other Adverse Events
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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:
unchecked 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.
unchecked 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.


Limitations and Caveats
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
No text entered.  


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