Intensive Glycemic Control and Skeletal Health Study - Full Text View

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00324350

Purpose

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.

Condition	Intervention	Phase
Atherosclerosis Cardiovascular Diseases Hypercholesterolemia Hypertension Diabetes Mellitus Coronary Disease	Drug: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents	Phase III

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol Coronary Artery Disease Diabetes Fractures High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Active Control, Factorial Assignment, Efficacy Study
Official Title:	Intensive Glycemic Control and Skeletal Health Study - Ancillary Study to the Action to Control Cardiovascular Risk in Diabetes Trial (ACCORD-BONE)

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Non-vertebral fractures [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Falls [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Height loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment:	7145
Study Start Date:	October 2003
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
1: Active Comparator intensive glycemic control	Drug: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents type 2 diabetes treatments as per standard of care
2: Active Comparator standard glycemic control	Drug: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents type 2 diabetes treatments as per standard of care

Detailed 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.

Eligibility

Ages Eligible for Study:	40 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00324350

Locations

United States, Minnesota
Berman Center for Outcomes & Clinical Research
Minneapolis, Minnesota, United States, 55404
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27106
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Tennessee
Veterans Affairs
Memphis, Tennessee, United States, 38104
Canada, Ontario
Population Health Research Institute
Hamilton, Ontario, Canada

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Principal Investigator:

Ann V. Schwartz, PhD

University of California, San Francisco

More Information

ACCORD-BONE Sub-Study Website This link exits the ClinicalTrials.gov site

Responsible Party:	University of California, San Francisco ( Ann V. Schwartz )
Study ID Numbers:	R01-DK069514
Study First Received:	May 10, 2006
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00324350
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Diabetes Mellitus
Fracture
Falls
Height Loss

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Hyperlipidemias
Metabolic Diseases
Heart Diseases
Myocardial Ischemia
Fractures, Bone
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Arteriosclerosis

Ischemia
Coronary Disease
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypercholesterolemia
Dyslipidemias
Coronary Artery Disease
Lipid Metabolism Disorders
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009