Trial Outcomes & Findings for Fracture Risk With Thiazolidinediones (NCT NCT01055223)
NCT ID: NCT01055223
Last Updated: 2017-05-30
Results Overview
ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.
COMPLETED
98483 participants
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
2017-05-30
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
98483
|
|
Overall Study
COMPLETED
|
98483
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fracture Risk With Thiazolidinediones
Baseline characteristics by cohort
| Measure |
TZD 6-month Cohort (Including TZD 12-month Cohort)
n=98483 Participants
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.
|
|---|---|
|
Age, Continuous
|
52.2 Years
STANDARD_DEVIATION 8.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37738 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60745 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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, 2008Population: 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.
ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.
Outcome measures
| Measure |
TZD Alone
n=21621 Participants
Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected.
|
TZD+Spironolactone
n=397 Participants
Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected.
|
TZD+Amiloride
n=43 Participants
Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
|
Other
n=3 Participants
Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
|
|---|---|---|---|---|
|
Number of Low Impact Fractures in Males and Females After 6 Months of Exposure to TZD
Case
|
4325 fractures
|
105 fractures
|
12 fractures
|
1 fractures
|
|
Number of Low Impact Fractures in Males and Females After 6 Months of Exposure to TZD
Control
|
17296 fractures
|
292 fractures
|
31 fractures
|
2 fractures
|
PRIMARY outcome
Timeframe: 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, 2008Population: The study population consisted 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 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.
ICD-9 codes (805-807.4x, 808-810.xx, 812-829.xx) were captured from Uniform Billing-92 records and Health Care Finance Administration records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for any low impact fracture occurring after the study period begin date (earliest date of the first TZD prescription). For each subject defined as case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched to cases on age (+ 5 years), gender, and year of fracture diagnosis.
Outcome measures
| Measure |
TZD Alone
n=13115 Participants
Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected.
|
TZD+Spironolactone
n=245 Participants
Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected.
|
TZD+Amiloride
n=28 Participants
Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
|
Other
n=2 Participants
Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
|
|---|---|---|---|---|
|
Number of Low Impact Fractures in Males and Females After 12 Months of Exposure to TZD
Case
|
2619 fractures
|
64 fractures
|
8 fractures
|
0 fractures
|
|
Number of Low Impact Fractures in Males and Females After 12 Months of Exposure to TZD
Control
|
10496 fractures
|
181 fractures
|
20 fractures
|
2 fractures
|
SECONDARY outcome
Timeframe: 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, 2008Population: The study population consisted 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 of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.
ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.
Outcome measures
| Measure |
TZD Alone
n=10778 Participants
Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected.
|
TZD+Spironolactone
n=196 Participants
Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected.
|
TZD+Amiloride
n=20 Participants
Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
|
Other
n=3 Participants
Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
|
|---|---|---|---|---|
|
Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 6 Months of Exposure to TZD
Case
|
2163 fractures
|
48 fractures
|
2 fractures
|
1 fractures
|
|
Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 6 Months of Exposure to TZD
Control
|
8615 fractures
|
148 fractures
|
18 fractures
|
2 fractures
|
SECONDARY outcome
Timeframe: 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, 2008Population: The study population consisted 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 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.
ICD-9 codes (815.0x, 816.0x, 817.0x, 825.0x, 825.2x, 826.0x, 812.0x, 812.2x, 812.4x, 814.0x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hand, foot, upper arm, and wrist fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.
Outcome measures
| Measure |
TZD Alone
n=6400 Participants
Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected.
|
TZD+Spironolactone
n=123 Participants
Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected.
|
TZD+Amiloride
n=12 Participants
Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
|
Other
n=2 Participants
Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
|
|---|---|---|---|---|
|
Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 12 Months of Exposure to TZD
Control
|
5115 fractures
|
94 fractures
|
12 fractures
|
2 fractures
|
|
Number of Fractures of the Hand, Foot, Upper Arm, and Wrist in Males and Females After 12 Months of Exposure to TZD
Case
|
1285 fractures
|
29 fractures
|
0 fractures
|
0 fractures
|
SECONDARY outcome
Timeframe: 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, 2008Population: The study population consisted 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 of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.
ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.
Outcome measures
| Measure |
TZD Alone
n=479 Participants
Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected.
|
TZD+Spironolactone
n=10 Participants
Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected.
|
TZD+Amiloride
Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
|
Other
Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
|
|---|---|---|---|---|
|
Number of Hip Fractures Combined in Males and Females After 6 Months of Exposure to TZD
Case
|
92 fractures
|
6 fractures
|
—
|
—
|
|
Number of Hip Fractures Combined in Males and Females After 6 Months of Exposure to TZD
Control
|
387 fractures
|
4 fractures
|
—
|
—
|
SECONDARY outcome
Timeframe: 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, 2008Population: The study population consisted 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 12 months of exposure to TZD (RSG, PIO or troglitazone) during their follow-up time available in the database.
ICD-9 codes (820.0x, 820.2x, 820.8x) were captured from UB-92 records and HCFA 1500 records. Case is defined as incident cases of fracture with an ICD-9 diagnostic code for hip fracture after the study period begin date (earliest date of the first TZD prescription). For each case, up to four controls were randomly selected from patients with type 2 diabetes exposed to TZD without a fracture diagnosis during follow-up and matched on age (+ 5 yrs), gender, and year of fracture diagnosis.
Outcome measures
| Measure |
TZD Alone
n=226 Participants
Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected.
|
TZD+Spironolactone
n=3 Participants
Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected.
|
TZD+Amiloride
Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
|
Other
Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
|
|---|---|---|---|---|
|
Number of Hip Fractures Combined in Males and Females After 12 Months of Exposure to TZD
Case
|
44 fractures
|
2 fractures
|
—
|
—
|
|
Number of Hip Fractures Combined in Males and Females After 12 Months of Exposure to TZD
Control
|
182 fractures
|
1 fractures
|
—
|
—
|
Adverse Events
TZD 6-month Cohort
TZD-12 Month Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER