Intensive Glycemic Control vs Standard Glycemic Control: Number of Participants With at Least One Non-vertebral Fracture
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0542 | 0.0473 | 0.062 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.052 | 0.0453 | 0.0597 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00213 | -0.0082 | 0.0125 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.857 | 1.26 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.04 | 0.85 | 1.28 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Intensive Glycemic Control than on Standard Glycemic Control | 468 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Intensive Glycemic Control | intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors | 198 | 3,655 | OG000 | ClinicalTrials.gov |
| Group 2 | Standard Glycemic Control | standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors | 189 | 3,632 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants With at Least One Non-vertebral Fracture | ClinicalTrials.gov |
| Description | 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. | ClinicalTrials.gov |
| Time frame | Average follow-up of 3.8 years | ClinicalTrials.gov |
| Population | As per protocol, pathological fractures, confirmed as occurring secondary to neoplasm, necrosis, or sepsis, and periprosthetic fractures were excluded (N=7). These analyses are limited to confirmed fractures that occurred on or before Feb 5, 2008, when the intensive glycemia intervention was ended. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Intensive Glycemic Control and Skeletal Health Study | ClinicalTrials.gov |
| NCT number | NCT00324350 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia, Hypertension, Diabetes Mellitus, Coronary Disease | ClinicalTrials.gov |
| Interventions | hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents | ClinicalTrials.gov |
| Lead sponsor | University of California, San Francisco | ClinicalTrials.gov |
| Results first posted | 2012-10-05 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00324350?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.