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Intensive Glycemic Control and Skeletal Health Study

NCT ID: NCT00324350

Last Updated: 2012-10-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7287 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atherosclerosis Cardiovascular Diseases Hypercholesterolemia Hypertension Diabetes Mellitus Coronary Disease

Keywords

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Diabetes Mellitus Fracture Falls Height Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents

Intervention Type DRUG

type 2 diabetes treatments, per standard of care

2

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

Group Type ACTIVE_COMPARATOR

hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents

Intervention Type DRUG

type 2 diabetes treatments, per standard of care

Interventions

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hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents

type 2 diabetes treatments, per standard of care

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann V. Schwartz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Berman Center for Outcomes & Clinical Research

Minneapolis, Minnesota, United States

Site Status

Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Veterans Affairs

Memphis, Tennessee, United States

Site Status

Population Health Research Institute

Hamilton, Ontario, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type RESULT
PMID: 22723583 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26305617 (View on PubMed)

Other Identifiers

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R01DK069514

Identifier Type: NIH

Identifier Source: org_study_id

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