Intensive Glycemic Control and Skeletal Health Study

NCT00324350 | Completed Phase 3 Results DMC

• 1 other identifier: R01DK069514
• Study Type: interventional
• Target: 7,287
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

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

Keywords

Diabetes Mellitus; Fracture; Falls; Height Loss

Outcome Measures

Primary Outcomes (2)

• Number of Participants With at Least One Non-vertebral Fracture

  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.

  Average follow-up of 3.8 years

• Number of Participants With at Least One Fall

  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.

  Average follow-up of 2.0 years

Secondary Outcomes (1)

• Number of Participants With > 2 cm of Height Loss

  5 years

Study Arms (2)

1

ACTIVE COMPARATOR

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

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

2

ACTIVE COMPARATOR

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

Interventions

hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents DRUG

type 2 diabetes treatments, per standard of care

1; 2

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have been randomized into the ACCORD study and be a participant from the five CCNs in the ACCORD-BONE ancillary study.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (5)

Berman Center for Outcomes & Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Wake Forest University

Winston-Salem, North Carolina, 27106, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Veterans Affairs

Memphis, Tennessee, 38104, United States

Location

Population Health Research Institute

Hamilton, Ontario, Canada

Location

Related Publications (2)

• Schwartz AV, Margolis KL, Sellmeyer DE, Vittinghoff E, Ambrosius WT, Bonds DE, Josse RG, Schnall AM, Simmons DL, Hue TF, Palermo L, Hamilton BP, Green JB, Atkinson HH, O'Connor PJ, Force RW, Bauer DC. Intensive glycemic control is not associated with fractures or falls in the ACCORD randomized trial. Diabetes Care. 2012 Jul;35(7):1525-31. doi: 10.2337/dc11-2184.

  PMID: 22723583 RESULT

• Schwartz AV, Chen H, Ambrosius WT, Sood A, Josse RG, Bonds DE, Schnall AM, Vittinghoff E, Bauer DC, Banerji MA, Cohen RM, Hamilton BP, Isakova T, Sellmeyer DE, Simmons DL, Shibli-Rahhal A, Williamson JD, Margolis KL. Effects of TZD Use and Discontinuation on Fracture Rates in ACCORD Bone Study. J Clin Endocrinol Metab. 2015 Nov;100(11):4059-66. doi: 10.1210/jc.2015-1215. Epub 2015 Aug 25.

  PMID: 26305617 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Cardiovascular Diseases; Hypercholesterolemia; Hypertension; Diabetes Mellitus; Coronary Disease; Fractures, Bone

Interventions

Hypoglycemic Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Limitations and Caveats

The initial identification of a possible fracture event relied on self-report at annual visits with the possibility of under- or over-reporting of fractures.

Results Point of Contact

• Title: Dr. Ann Schwartz
• Organization: University of California, San Francisco

aschwartz@psg.ucsf.edu

415-514-8000

Study Officials

• Ann V. Schwartz, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2006
• First Posted: May 11, 2006
• Study Start: October 1, 2003
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 5, 2012
• Results First Posted: October 5, 2012

Record last verified: 2012-09

Locations

US (4); CA (1)