| Trial ID: | L4852 |
| Source ID: | NCT00324350
|
| Associated Drug: |
Hypoglycemic Agents, Hydroxymethylglutaryl-Coa Reductase Inhibitors, Hypertensive Agents
|
| Title: |
Intensive Glycemic Control and Skeletal Health Study
|
| Acronym: |
ACCORD-BONE
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00324350/results
|
| Conditions: |
Atherosclerosis|Cardiovascular Diseases|Hypercholesterolemia|Hypertension|Diabetes Mellitus|Coronary Disease
|
| Interventions: |
DRUG: hypoglycemic agents, hydroxymethylglutaryl-CoA Reductase inhibitors, hypertensive agents
|
| Outcome Measures: |
Primary: Number of Participants With at Least One Non-vertebral Fracture, 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., Average follow-up of 3.8 years|Number of Participants With at Least One Fall, At each annual visit starting in January 2006, participants were also asked about falling: "In the last 12 months have you fallen and landed on the floor or ground, OR fallen and hit an object like a table or stair?" Those who answered "yes" were also asked how many times they had fallen in the previous 12 months., Average follow-up of 2.0 years | Secondary: Number of Participants With > 2 cm of Height Loss, Standing height was measured according to a standard protocol at baseline and annual visits on all ACCORD participants. Height loss was compared by treatment assignment using linear mixed models with random intercepts and slopes. Treatment effects were captured by the interaction between treatment assignment and time. The proportions losing \>2 cm of height during follow-up were compared using logistic models. This degree of height loss is associated with incident vertebral fracture with 94% specificity but only 28% sensitivity, 5 years
|
| Sponsor/Collaborators: |
Sponsor: University of California, San Francisco | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
7287
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2003-10
|
| Completion Date: |
2009-06
|
| Results First Posted: |
2012-10-05
|
| Last Update Posted: |
2012-10-05
|
| Locations: |
Berman Center for Outcomes & Clinical Research, Minneapolis, Minnesota, 55404, United States|Wake Forest University, Winston-Salem, North Carolina, 27106, United States|Case Western Reserve University, Cleveland, Ohio, 44106, United States|Veterans Affairs, Memphis, Tennessee, 38104, United States|Population Health Research Institute, Hamilton, Ontario, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT00324350
|
