Phase 3 N=7,287 Randomized Single-blind Prevention

Intensive Glycemic Control and Skeletal Health Study

Atherosclerosis · Cardiovascular Diseases · Hypercholesterolemia · Hypertension · Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT00324350 ↗

Enrolled (actual)

7,287

Serious AEs

—

Results posted

Oct 2012

Primary outcome: Primary: Number of Participants With at Least One Non-vertebral Fracture — 198; 189 participants — p=0.678

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: University of California, San Francisco
Primary completion: Jun 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With at Least One Non-vertebral Fracture	198; 189	0.678
PRIMARY Number of Participants With at Least One Fall	1122; 1133	0.490
SECONDARY Number of Participants With > 2 cm of Height Loss	678; 686	0.854

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00324350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.