Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: Clinical tests
* Diagnostic Test: Clinical tests
* Diagnostic Test: Biochemical tests
* Diagnostic Test: DXA scan
* Diagnostic Test: AGE Reader


Participation Criteria
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Eligibility Criteria
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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 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, SGLT-2 (sodium-glucose cotransporter-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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with type 1 diabetes<br> | Diagnostic Test: Clinical tests<br>* The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.<br>Diagnostic Test: Biochemical tests<br>* The investigators perform blood and urine tests in every participant.<br>Diagnostic Test: DXA scan<br>* The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.<br>Diagnostic Test: AGE Reader<br>* The investigators perform a skin AGE (advanced glycation end products) measurement with the AGE Reader machine in every participant.<br>|
| Healthy controls<br> | Diagnostic Test: Clinical tests<br>* The investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant.<br>Diagnostic Test: Biochemical tests<br>* The investigators perform blood and urine tests in every participant.<br>Diagnostic Test: DXA scan<br>* The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.<br>Diagnostic Test: AGE Reader<br>* The investigators perform a skin AGE (advanced glycation end products) measurement with the AGE Reader machine in every participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vertebral fracture detected with VFA | Vertebral Fracture Assessment (VFA) software of dual-energy X-ray absorptiometry (DXA scan) is used to identify vertebral fractures. If there is evidence of a vertebral fracture on VFA, a lateral and anteroposterior spine X-ray will be obtained to confirm the VFA results. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Areal bone mineral density of the spine in g/cm2 | Measured by DXA scan | Baseline | 
| Areal bone mineral density of the spine, T-score | Measured by DXA scan | Baseline | 
| Areal bone mineral density of the spine, Z-score | Measured by DXA scan | Baseline | 
| Areal bone mineral density of proximal femur in g/cm2 | Measured by DXA scan | Baseline | 
| Areal bone mineral density of proximal femur, T-score | Measured by DXA scan | Baseline | 
| Areal bone mineral density of proximal femur, Z-score | Measured by DXA scan | Baseline | 
| Areal bone mineral density of total hip in g/cm2 | Measured by DXA scan | Baseline | 
| Areal bone mineral density of total hip, T-score | Measured by DXA scan | Baseline | 
| Areal bone mineral density of total hip, Z-score | Measured by DXA scan | Baseline | 
| Areal bone mineral density of distal radius in g/cm2 | Measured by DXA scan | Baseline | 
| Areal bone mineral density of distal radius, T-score | Measured by DXA scan | Baseline | 
| Areal bone mineral density of distal radius, Z-score | Measured by DXA scan | Baseline | 
| Lean mass (arm, leg, trunk, android, gynoid and total) | Body composition measured by DXA scan | Baseline | 
| Fat mass (arm, leg, trunk, android, gynoid and total) | Body composition measured by DXA scan | Baseline | 
| Skin AGE measurement | Measured by AGE Reader | Baseline | 
| C-telopeptide | Bone turnover marker (serum) | Baseline | 
| Sclerostin | Bone turnover marker (serum) | Baseline | 
| Osteocalcin | Bone turnover marker (serum) | Baseline |