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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00324350
First received: May 10, 2006
Last updated: September 5, 2012
Last verified: September 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Intensive Glycemic Control and Skeletal Health Study - Ancillary Study to the Action to Control Cardiovascular Risk in Diabetes Trial (ACCORD-BONE)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Number of Participants With at Least One Non-vertebral Fracture [ Time Frame: Average follow-up of 3.8 years ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With at Least One Fall [ Time Frame: Average follow-up of 2.0 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With > 2 cm of Height Loss [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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


Enrollment: 7287
Study Start Date: October 2003
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
intensive glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level below 6.0%)
Drug: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents
type 2 diabetes treatments, per standard of care
Active Comparator: 2
standard glycemic control (therapeutic strategy that targets a glycosylated hemoglobin (HbA1c) level of 7 to 7.9%)
Drug: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents
type 2 diabetes treatments, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of California, San Francisco
Investigators
Principal Investigator: Ann V. Schwartz, PhD University of California, San Francisco
  More Information

Additional Information:
No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00324350     History of Changes
Other Study ID Numbers: R01-DK069514
Study First Received: May 10, 2006
Results First Received: March 15, 2012
Last Updated: September 5, 2012
Health Authority: United States: Federal Government

Keywords provided by University of California, San Francisco:
Diabetes Mellitus
Fracture
Falls
Height Loss

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Diabetes Mellitus
Hypercholesterolemia
Hypertension
Arterial Occlusive Diseases
Vascular Diseases
Myocardial Ischemia
Heart Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Hypoglycemic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Physiological Effects of Drugs
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014