Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes

Completed

• Conditions: Bone Fracture; Diabetes Mellitus, Type 1; Bone Health
• Interventions: Diagnostic Test: Clinical tests; Diagnostic Test: Biochemical tests; Diagnostic Test: DXA scan; Diagnostic Test: AGE Reader

• Registration Number: NCT04064437
• Lead Sponsor: CHU de Quebec-Universite Laval

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-29
• Study First Submitted: 2019-08-17
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Primary Completion: 2021-03-02
• Study Completion: 2021-03-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with type 1 diabetes	Biochemical tests	-
Healthy controls	Clinical tests	-
Healthy controls	DXA scan	-
Healthy controls	Biochemical tests	-
Healthy controls	AGE Reader	-
Individuals with type 1 diabetes	Clinical tests	-
Individuals with type 1 diabetes	AGE Reader	-
Individuals with type 1 diabetes	DXA scan	-

Primary Outcome Measures

Name	Time	Method
Vertebral fracture detected with VFA	Baseline	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Centre de recherche du CHU de Québec - Université Laval; 🇨🇦 Québec, Canada

Institut de recherches cliniques de Montréal (IRCM); 🇨🇦 Montréal, Quebec, Canada