Clinical trial NCT04064437: Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes
Official title: Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes (Diabetes Spine Fractures, DenSiFy)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Bone Fracture
Bone Health
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 192
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 127 individuals with type 1 diabetes and 64 healthy subjects

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.


Eligibility 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.

Primary outcomes:
measure: Vertebral fracture detected with VFA
timeFrame: Baseline
Secondary outcomes:
measure: Areal bone mineral density of the spine in g/cm2
timeFrame: Baseline
measure: Areal bone mineral density of the spine, T-score
timeFrame: Baseline
measure: Areal bone mineral density of the spine, Z-score
timeFrame: Baseline
measure: Areal bone mineral density of proximal femur in g/cm2
timeFrame: Baseline
measure: Areal bone mineral density of proximal femur, T-score
timeFrame: Baseline
measure: Areal bone mineral density of proximal femur, Z-score
timeFrame: Baseline
measure: Areal bone mineral density of total hip in g/cm2
timeFrame: Baseline
measure: Areal bone mineral density of total hip, T-score
timeFrame: Baseline
measure: Areal bone mineral density of total hip, Z-score
timeFrame: Baseline
measure: Areal bone mineral density of distal radius in g/cm2
timeFrame: Baseline
measure: Areal bone mineral density of distal radius, T-score
timeFrame: Baseline
measure: Areal bone mineral density of distal radius, Z-score
timeFrame: Baseline
measure: Lean mass (arm, leg, trunk, android, gynoid and total)
timeFrame: Baseline
measure: Fat mass (arm, leg, trunk, android, gynoid and total)
timeFrame: Baseline
measure: Skin AGE measurement
timeFrame: Baseline
measure: C-telopeptide
timeFrame: Baseline
measure: Sclerostin
timeFrame: Baseline
measure: Osteocalcin
timeFrame: Baseline
Other outcomes:
measure: HbA1C
timeFrame: Baseline
measure: Hemoglobin
timeFrame: Baseline
measure: Creatinine
timeFrame: Baseline
measure: Lipid panel
timeFrame: Baseline
measure: Thyroid-stimulating hormone (TSH)
timeFrame: Baseline
measure: Calcium
timeFrame: Baseline
measure: Albumine
timeFrame: Baseline
measure: Phosphate
timeFrame: Baseline
measure: 25-Hydroxyvitamin D
timeFrame: Baseline
measure: Parathormone (PTH)
timeFrame: Baseline
measure: Insulin like growth factor-1 (IGF-1)
timeFrame: Baseline
measure: Antitransglutaminase antibodies
timeFrame: Baseline
measure: Immunoglobulin A (IgA)
timeFrame: Baseline
measure: Follicle stimulating hormone (FSH, women)
timeFrame: Baseline
measure: Total testosterone (men)
timeFrame: Baseline
measure: Sex hormone-binding globulin (SHBG, men)
timeFrame: Baseline
measure: Microalbuminuria
timeFrame: Baseline
Locations:
city: Montréal
country: Canada
facility: Institut de recherches cliniques de Montréal (IRCM)
state: Quebec
city: Québec
country: Canada
facility: Centre de recherche du CHU de Québec - Université Laval
Study officials:
affiliation: CHU de Québec - Université Laval
name: Claudia Gagnon, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.