Status:
COMPLETED
Intensive Glycemic Control and Skeletal Health Study
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Atherosclerosis
Cardiovascular Diseases
Eligibility:
All Genders
40-79 years
Phase:
PHASE3
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, f...
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
7287 Patients enrolled
Trial Details
Trial ID
NCT00324350
Start Date
October 1 2003
End Date
June 1 2009
Last Update
October 5 2012
Active Locations (5)
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1
Berman Center for Outcomes & Clinical Research
Minneapolis, Minnesota, United States, 55404
2
Wake Forest University
Winston-Salem, North Carolina, United States, 27106
3
Case Western Reserve University
Cleveland, Ohio, United States, 44106
4
Veterans Affairs
Memphis, Tennessee, United States, 38104