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Completed

NCT Number: NCT04064437

Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de recherches cliniques de Montréal (IRCM), Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical Tests

Diagnostic Test

The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.

Biochemical Tests

Diagnostic Test

The investigators perform blood and urine tests in every participant.

DXA scan

Diagnostic Test

The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.

AGE Reader

Diagnostic Test

The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.

Primary outcomes

  1. 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 outcomes

  1. Areal bone mineral density of the spine in g/cm2

    Time frame: Baseline

    Measured by DXA scan

  2. Areal bone mineral density of the spine, T-score

    Time frame: Baseline

    Measured by DXA scan

  3. Areal bone mineral density of the spine, Z-score

    Time frame: Baseline

    Measured by DXA scan

  4. Areal bone mineral density of proximal femur in g/cm2

    Time frame: Baseline

    Measured by DXA scan

  5. Areal bone mineral density of proximal femur, T-score

    Time frame: Baseline

    Measured by DXA scan

  6. Areal bone mineral density of proximal femur, Z-score

    Time frame: Baseline

    Measured by DXA scan

  7. Areal bone mineral density of total hip in g/cm2

    Time frame: Baseline

    Measured by DXA scan

  8. Areal bone mineral density of total hip, T-score

    Time frame: Baseline

    Measured by DXA scan

  9. Areal bone mineral density of total hip, Z-score

    Time frame: Baseline

    Measured by DXA scan

  10. Areal bone mineral density of distal radius in g/cm2

    Time frame: Baseline

    Measured by DXA scan

  11. Areal bone mineral density of distal radius, T-score

    Time frame: Baseline

    Measured by DXA scan

  12. Areal bone mineral density of distal radius, Z-score

    Time frame: Baseline

    Measured by DXA scan

  13. Lean mass (arm, leg, trunk, android, gynoid and total)

    Time frame: Baseline

    Body composition measured by DXA scan

  14. Fat mass (arm, leg, trunk, android, gynoid and total)

    Time frame: Baseline

    Body composition measured by DXA scan

  15. Skin AGE measurement

    Time frame: Baseline

    Measured by AGE Reader

  16. C-telopeptide

    Time frame: Baseline

    Bone turnover marker (serum)

  17. Sclerostin

    Time frame: Baseline

    Bone turnover marker (serum)

  18. Osteocalcin

    Time frame: Baseline

    Bone turnover marker (serum)

Other outcomes

  1. HbA1C

    Time frame: Baseline

    Diabetes control marker

  2. Hemoglobin

    Time frame: Baseline

    Blood level measurement

  3. Creatinine

    Time frame: Baseline

    Blood level measurement

  4. Lipid panel

    Time frame: Baseline

    Blood level measurement

  5. Thyroid-stimulating hormone (TSH)

    Time frame: Baseline

    Blood level measurement

  6. Calcium

    Time frame: Baseline

    Blood level measurement

  7. Albumine

    Time frame: Baseline

    Blood level measurement

  8. Phosphate

    Time frame: Baseline

    Blood level measurement

  9. 25-Hydroxyvitamin D

    Time frame: Baseline

    Blood level measurement

  10. Parathormone (PTH)

    Time frame: Baseline

    Blood level measurement

  11. Insulin like growth factor-1 (IGF-1)

    Time frame: Baseline

    Blood level measurement

  12. Antitransglutaminase antibodies

    Time frame: Baseline

    Blood level measurement

  13. Immunoglobulin A (IgA)

    Time frame: Baseline

    Blood level measurement

  14. Follicle stimulating hormone (FSH, women)

    Time frame: Baseline

    Blood level measurement

  15. Total testosterone (men)

    Time frame: Baseline

    Blood level measurement

  16. Sex hormone-binding globulin (SHBG, men)

    Time frame: Baseline

    Blood level measurement

  17. Microalbuminuria

    Time frame: Baseline

    Urine microalbuminuria / urine creatinine ratio measurement

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

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

Acronym: DenSiFy

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2019
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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