Trial Outcomes & Findings for Intensive Glycemic Control and Skeletal Health Study (NCT NCT00324350)
NCT ID: NCT00324350
Last Updated: 2012-10-05
Results Overview
The BONE ancillary study was initiated during recruitment for the main ACCORD trial. Beginning in January 2006, at the next annual visit participants were asked about the occurrence of any non-spine fractures since randomization. After the annual visit in 2006, participants were asked if they had suffered a fracture since their last annual visit. Reported fracture events were centrally adjudicated, based on radiology records, at the University of California, San Francisco (UCSF) with the adjudicators blinded to treatment assignment.
COMPLETED
PHASE3
7287 participants
Average follow-up of 3.8 years
2012-10-05
Participant Flow
The ACCORD trial has been described previously (Buse JB,et al. Am J Cardiol 99:21i-33i, 2007). Five of the 7 clinical center networks agreed to participate in the BONE ancillary study, including 54 of 77 clinical sites and 7,287 participants. The BONE ancillary study was initiated during the main recruitment for ACCORD (beginning in 2006).
Participant milestones
| Measure |
Intensive Glycemic Control
intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
|
Standard Glycemic Control
standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
|
|---|---|---|
|
Overall Study
STARTED
|
3655
|
3632
|
|
Overall Study
Non-Vertebral Fracture Follow-Up
|
3655
|
3632
|
|
Overall Study
Falls Follow-Up
|
3364
|
3418
|
|
Overall Study
COMPLETED
|
3655
|
3632
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intensive Glycemic Control and Skeletal Health Study
Baseline characteristics by cohort
| Measure |
Intensive Glycemic Control
n=3655 Participants
intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
|
Standard Glycemic Control
n=3632 Participants
standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
|
Total
n=7287 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2380 Participants
n=5 Participants
|
2361 Participants
n=7 Participants
|
4741 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1275 Participants
n=5 Participants
|
1271 Participants
n=7 Participants
|
2546 Participants
n=5 Participants
|
|
Age Continuous
|
62.5 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
62.5 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1267 Participants
n=5 Participants
|
1251 Participants
n=7 Participants
|
2518 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2388 Participants
n=5 Participants
|
2381 Participants
n=7 Participants
|
4769 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2903 participants
n=5 Participants
|
2876 participants
n=7 Participants
|
5779 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
752 participants
n=5 Participants
|
756 participants
n=7 Participants
|
1508 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average follow-up of 3.8 yearsPopulation: As per protocol, pathological fractures, confirmed as occurring secondary to neoplasm, necrosis, or sepsis, and periprosthetic fractures were excluded (N=7). These analyses are limited to confirmed fractures that occurred on or before Feb 5, 2008, when the intensive glycemia intervention was ended.
The BONE ancillary study was initiated during recruitment for the main ACCORD trial. Beginning in January 2006, at the next annual visit participants were asked about the occurrence of any non-spine fractures since randomization. After the annual visit in 2006, participants were asked if they had suffered a fracture since their last annual visit. Reported fracture events were centrally adjudicated, based on radiology records, at the University of California, San Francisco (UCSF) with the adjudicators blinded to treatment assignment.
Outcome measures
| Measure |
Intensive Glycemic Control
n=3655 Participants
intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
|
Standard Glycemic Control
n=3632 Participants
standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
|
|---|---|---|
|
Number of Participants With at Least One Non-vertebral Fracture
|
198 participants
Interval 0.86 to 0.127
|
189 participants
|
PRIMARY outcome
Timeframe: Average follow-up of 2.0 yearsPopulation: These analyses include results from the annual visits that occurred before Feb 5, 2008, the close of the intensive glycemia arm. Of those in the BONE ancillary study, 6,782 participants answered at least one question about falls.
At each annual visit starting in January 2006, participants were also asked about falling: "In the last 12 months have you fallen and landed on the floor or ground, OR fallen and hit an object like a table or stair?" Those who answered "yes" were also asked how many times they had fallen in the previous 12 months.
Outcome measures
| Measure |
Intensive Glycemic Control
n=3364 Participants
intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
|
Standard Glycemic Control
n=3418 Participants
standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
|
|---|---|---|
|
Number of Participants With at Least One Fall
|
1122 participants
|
1133 participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Among participants in the BONE ancillary study, 6,979 participants had at least one height measurement during follow-up and were included in these analyses.
Standing height was measured according to a standard protocol at baseline and annual visits on all ACCORD participants. Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. Treatment effects were captured by the interaction between treatment assignment and time. The proportions losing \>2 cm of height during follow-up were compared using logistic models. This degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity
Outcome measures
| Measure |
Intensive Glycemic Control
n=3482 Participants
intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
|
Standard Glycemic Control
n=3497 Participants
standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
|
|---|---|---|
|
Number of Participants With > 2 cm of Height Loss
|
678 participants
|
686 participants
|
Adverse Events
Intensive Glycemic Control
Standard Glycemic Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ann Schwartz
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place