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Completed

NCT Number: NCT00324350

Intensive Glycemic Control and Skeletal Health Study

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Diabetes Mellitus Dyslipidemias Endocrine System Diseases Fractures, Bone Glucose Metabolism Disorders Heart Diseases Hypercholesterolemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases Wounds and Injuries

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Population Health Research Institute, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents

Drug

type 2 diabetes treatments, per standard of care

Primary outcomes

  1. Number of Participants With at Least One Non-vertebral Fracture

    Time frame: Average follow-up of 3.8 years

    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.

  2. Number of Participants With at Least One Fall

    Time frame: Average follow-up of 2.0 years

    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 outcomes

  1. Number of Participants With > 2 cm of Height Loss

    Time frame: 5 years

    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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

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

Registry information

Official study title

Intensive Glycemic Control and Skeletal Health Study - Ancillary Study to the Action to Control Cardiovascular Risk in Diabetes Trial (ACCORD-BONE)

Acronym: ACCORD-BONE

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
May 11, 2006
Registry last updated
Oct 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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