Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes

Overview

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.

Full Title of Study: “Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes (Diabetes Spine Fractures, DenSiFy)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: March 2, 2021

Interventions

  • 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.

Arms, Groups and Cohorts

  • Individuals with type 1 diabetes
  • Healthy controls

Clinical Trial Outcome Measures

Primary Measures

  • Vertebral fracture detected with VFA
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • CHU de Quebec-Universite Laval
  • Provider of Information About this Clinical Study
    • Principal Investigator: Claudia Gagnon, MD – CHU de Quebec-Universite Laval
  • Overall Official(s)
    • Claudia Gagnon, Dr, Principal Investigator, CHU de Québec – Université Laval

Citations Reporting on Results

Coll JC, Garceau E, Leslie WD, Genest M, Michou L, Weisnagel SJ, Mac-Way F, Albert C, Morin SN, Rabasa-Lhoret R, Gagnon C. Prevalence of Vertebral Fractures in Adults With Type 1 Diabetes: DenSiFy Study (Diabetes Spine Fractures). J Clin Endocrinol Metab. 2022 Apr 19;107(5):e1860-e1870. doi: 10.1210/clinem/dgac031.

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