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

Intensive Glycemic Control and Skeletal Health Study

Atherosclerosis · Cardiovascular Disease · Hypercholesterolemia · Hypertension

Source: ClinicalTrials.gov NCT00324350 ↗

Enrolled (actual)

7,287

Serious AEs

—

Results posted

Oct 2012

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

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.

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

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. Informational only — not medical advice.