NCT04064437

Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes

Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes (Diabetes Spine Fractures, DenSiFy)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 192 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

Background : Type 1 diabetes is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. The lower bone mineral density (BMD) observed in individuals with type 1 diabetes cannot solely explain the higher fracture incidence. Bone microarchitecture defects significantly contribute to bone fragility. Few studies assessed spine fractures in type 1 diabetes. This cross-sectional multicenter case-control study aims (1) to evaluate the prevalence of asymptomatic vertebral fractures in individuals with type 1 diabetes in comparison to age- and sex-matched healthy controls; (2) to compare individuals with diabetes with vertebral fractures and those without vertebral fracture using clinical, biochemical and radiological parameters.

Conditions

• Diabetes Mellitus, Type 1
• Bone Fracture
• Bone Health

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Clinical tests	The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
DIAGNOSTIC_TEST	Clinical tests	The investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant.
DIAGNOSTIC_TEST	Biochemical tests	The investigators perform blood and urine tests in every participant.
DIAGNOSTIC_TEST	DXA scan	The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
DIAGNOSTIC_TEST	AGE Reader	The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.

Timeline

• Start date: 2019-07-29
• Primary completion: 2021-03-02
• Completion: 2021-03-02
• First posted: 2019-08-21
• Last updated: 2024-02-13

Locations

2 sites across 1 country: Canada