Clinical trial NCT00324350: Intensive Glycemic Control and Skeletal Health Study
Official title: Intensive Glycemic Control and Skeletal Health Study - Ancillary Study to the Action to Control Cardiovascular Risk in Diabetes Trial (ACCORD-BONE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atherosclerosis
Cardiovascular Diseases
Hypercholesterolemia
Hypertension
Diabetes Mellitus
Coronary Disease
Keywords: Diabetes Mellitus
Fracture
Falls
Height Loss
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2006-05-11
Enrollment: 7287
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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, falls, and bone mineral density.

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 the risk of falling. The higher risk of fracture associated with type 2 diabetes is an important health burden for these patients. More frequent falls and perhaps reduced bone strength in those with diabetes are thought to be key contributing factors. The best approach to preventing fractures in type 2 diabetes is not yet understood. There is observational evidence to support our hypothesis that better glycemic control will preserve bone and reduce falls and fractures. The ACCORD-BONE study provides a unique opportunity to determine whether intensive glycemic control will prevent fractures, falls, and bone loss in older diabetic adults, which may lead to improved treatment and prevention in the future.

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

Primary outcomes:
measure: Number of Participants With at Least One Non-vertebral Fracture
timeFrame: Average follow-up of 3.8 years
measure: Number of Participants With at Least One Fall
timeFrame: Average follow-up of 2.0 years
Secondary outcomes:
measure: Number of Participants With > 2 cm of Height Loss
timeFrame: 5 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Berman Center for Outcomes & Clinical Research
state: Minnesota
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Memphis
country: United States
facility: Veterans Affairs
state: Tennessee
city: Hamilton
country: Canada
facility: Population Health Research Institute
state: Ontario
Study officials:
affiliation: University of California, San Francisco
name: Ann V. Schwartz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwartz AV, Margolis KL, Sellmeyer DE, Vittinghoff E, Ambrosius WT, Bonds DE, Josse RG, Schnall AM, Simmons DL, Hue TF, Palermo L, Hamilton BP, Green JB, Atkinson HH, O'Connor PJ, Force RW, Bauer DC. Intensive glycemic control is not associated with fractures or falls in the ACCORD randomized trial. Diabetes Care. 2012 Jul;35(7):1525-31. doi: 10.2337/dc11-2184.
citation: Schwartz AV, Chen H, Ambrosius WT, Sood A, Josse RG, Bonds DE, Schnall AM, Vittinghoff E, Bauer DC, Banerji MA, Cohen RM, Hamilton BP, Isakova T, Sellmeyer DE, Simmons DL, Shibli-Rahhal A, Williamson JD, Margolis KL. Effects of TZD Use and Discontinuation on Fracture Rates in ACCORD Bone Study. J Clin Endocrinol Metab. 2015 Nov;100(11):4059-66. doi: 10.1210/jc.2015-1215. Epub 2015 Aug 25.