Intensive Glycemic Control and Skeletal Health Study (ACCORD-BONE)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 3

Conditions: Hypertension; Hypercholesterolemia; Diabetes Mellitus; Cardiovascular Diseases; Coronary Disease; Atherosclerosis

Treatments: Drug: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00324350

R01DK069514

Details and patient eligibility

About

The purpose of the ACCORD-BONE Study is to investigate the effects of intensive glycemic control for type 2 diabetes (in ACCORD participants) on factors related to bone health, including, fractures, falls, and bone mineral density.

Full description

Recent studies have established that type 2 diabetes is a risk factor for fractures, particularly of the hip, shoulder and foot. Additionally, type 2 diabetes is associated with a 50-60% increase in the risk of falling. The higher risk of fracture associated with type 2 diabetes is an important health burden for these patients. More frequent falls and perhaps reduced bone strength in those with diabetes are thought to be key contributing factors. The best approach to preventing fractures in type 2 diabetes is not yet understood. There is observational evidence to support our hypothesis that better glycemic control will preserve bone and reduce falls and fractures. The ACCORD-BONE study provides a unique opportunity to determine whether intensive glycemic control will prevent fractures, falls, and bone loss in older diabetic adults, which may lead to improved treatment and prevention in the future.

Enrollment: 7,287 patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fulfills criteria for inclusion in the ACCORD main trial
• Must have been randomized into the ACCORD study and be a participant from the five CCNs in the ACCORD-BONE ancillary study.

Exclusion criteria

• Fulfills criteria for exclusion in the ACCORD main trial

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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7,287 participants in 2 patient groups

1

Active Comparator group

Description:

intensive glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level below 6.0%)

Treatment:

Drug: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents

2

Active Comparator group

Description:

standard glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level of 7 to 7.9%)

Treatment:

Drug: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents