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

Laval University

Status

Completed

Conditions

Diabetes Mellitus, Type 1

Bone Health

Bone Fracture

Treatments

Diagnostic Test: Clinical tests

Diagnostic Test: AGE Reader

Diagnostic Test: DXA scan

Diagnostic Test: Biochemical tests

Study type

Observational

Funder types

Other

Identifiers

NCT04064437

2019-4550

Details and patient eligibility

About

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.

Enrollment

192 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Individuals with type 1 diabetes

Inclusion Criteria:

Diagnosis of type 1 diabetes for at least 5 years;
Age 20 years and older.

Exclusion Criteria:

Pregnancy or breastfeeding;
Conditions associated with bone disease (significant liver disease, intestinal malabsorption other than celiac disease, organ transplant, active cancer, rheumatoid arthritis, hyperthyroidism, hypothyroidism with abnormal thyroid-stimulating hormone (TSH), hyperparathyroidism, hypoparathyroidism, acromegaly, Cushing syndrome, adrenal insufficiency);
Any of these medications in the past 6 months : glucocorticoids ≥ 7,5 mg prednisone/day or equivalency ≥ 3 months, aromatase inhibitors, antiandrogens, antiepileptic drugs, anticoagulants, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, thiazolidinediones;
Past medical history of traumatic vertebral fracture;
Inability to consent.

Healthy controls

Inclusion Criteria:

Age 20 years and older.

Exclusion Criteria:

As above (as individuals with diabetes), and :
Diagnosis of diabetes or prediabetes;
Celiac disease;
Chronic kidney disease (CrCl < 60 mL/min);
Any of theses medications in the past 6 months : biphosphonates, teriparatide, denosumab, calcitonin;
Past medical history of fragility fracture.