Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

— DenSiFy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04064437
• Other study ID #: 2019-4550
• Status: Completed
• Start date: July 29, 2019
• Est. completion date: March 2, 2021

Study information

• Verified date: February 2024
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: March 2, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Fracture
• Bone Health
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Fractures, Bone
• Spinal Fractures

Intervention

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.
• Clinical tests
The investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant.
• Biochemical tests
The investigators perform blood and urine tests in every participant.
• DXA scan
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
• AGE Reader
The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal (IRCM)	Montréal	Quebec
Canada	Centre de recherche du CHU de Québec - Université Laval	Québec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HbA1C	Diabetes control marker	Baseline
Other	Hemoglobin	Blood level measurement	Baseline
Other	Creatinine	Blood level measurement	Baseline
Other	Lipid panel	Blood level measurement	Baseline
Other	Thyroid-stimulating hormone (TSH)	Blood level measurement	Baseline
Other	Calcium	Blood level measurement	Baseline
Other	Albumine	Blood level measurement	Baseline
Other	Phosphate	Blood level measurement	Baseline
Other	25-Hydroxyvitamin D	Blood level measurement	Baseline
Other	Parathormone (PTH)	Blood level measurement	Baseline
Other	Insulin like growth factor-1 (IGF-1)	Blood level measurement	Baseline
Other	Antitransglutaminase antibodies	Blood level measurement	Baseline
Other	Immunoglobulin A (IgA)	Blood level measurement	Baseline
Other	Follicle stimulating hormone (FSH, women)	Blood level measurement	Baseline
Other	Total testosterone (men)	Blood level measurement	Baseline
Other	Sex hormone-binding globulin (SHBG, men)	Blood level measurement	Baseline
Other	Microalbuminuria	Urine microalbuminuria / urine creatinine ratio measurement	Baseline
Primary	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	Areal bone mineral density of the spine in g/cm2	Measured by DXA scan	Baseline
Secondary	Areal bone mineral density of the spine, T-score	Measured by DXA scan	Baseline
Secondary	Areal bone mineral density of the spine, Z-score	Measured by DXA scan	Baseline
Secondary	Areal bone mineral density of proximal femur in g/cm2	Measured by DXA scan	Baseline
Secondary	Areal bone mineral density of proximal femur, T-score	Measured by DXA scan	Baseline
Secondary	Areal bone mineral density of proximal femur, Z-score	Measured by DXA scan	Baseline
Secondary	Areal bone mineral density of total hip in g/cm2	Measured by DXA scan	Baseline
Secondary	Areal bone mineral density of total hip, T-score	Measured by DXA scan	Baseline
Secondary	Areal bone mineral density of total hip, Z-score	Measured by DXA scan	Baseline
Secondary	Areal bone mineral density of distal radius in g/cm2	Measured by DXA scan	Baseline
Secondary	Areal bone mineral density of distal radius, T-score	Measured by DXA scan	Baseline
Secondary	Areal bone mineral density of distal radius, Z-score	Measured by DXA scan	Baseline
Secondary	Lean mass (arm, leg, trunk, android, gynoid and total)	Body composition measured by DXA scan	Baseline
Secondary	Fat mass (arm, leg, trunk, android, gynoid and total)	Body composition measured by DXA scan	Baseline
Secondary	Skin AGE measurement	Measured by AGE Reader	Baseline
Secondary	C-telopeptide	Bone turnover marker (serum)	Baseline
Secondary	Sclerostin	Bone turnover marker (serum)	Baseline
Secondary	Osteocalcin	Bone turnover marker (serum)	Baseline