Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes
DenSiFy
1 other identifier
observational
192
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 29, 2019
CompletedFirst Submitted
Initial submission to the registry
August 17, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2021
CompletedFebruary 13, 2024
February 1, 2024
1.6 years
August 17, 2019
February 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
Areal bone mineral density of the spine in g/cm2
Baseline
Areal bone mineral density of the spine, T-score
Baseline
Areal bone mineral density of the spine, Z-score
Baseline
Areal bone mineral density of proximal femur in g/cm2
Baseline
Areal bone mineral density of proximal femur, T-score
Baseline
- +13 more secondary outcomes
Other Outcomes (17)
HbA1C
Baseline
Hemoglobin
Baseline
Creatinine
Baseline
- +14 more other outcomes
Study Arms (2)
Individuals with type 1 diabetes
Healthy controls
Interventions
The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
The investigators perform blood and urine tests in every participant.
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.
Eligibility Criteria
127 individuals with type 1 diabetes and 64 healthy subjects
You may qualify if:
- Diagnosis of type 1 diabetes for at least 5 years;
- Age 20 years and older.
You may not qualify if:
- 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
- Age 20 years and older.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Institut de recherches cliniques de Montréal (IRCM)
Montreal, Quebec, H2W 1R7, Canada
Centre de recherche du CHU de Québec - Université Laval
Québec, G1V 4G2, Canada
Related 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. 2022 Apr 19;107(5):e1860-e1870. doi: 10.1210/clinem/dgac031.
PMID: 35090169RESULT
Biospecimen
Blood (serum and plasma)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudia Gagnon, Dr
CHU de Québec - Université Laval
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 17, 2019
First Posted
August 21, 2019
Study Start
July 29, 2019
Primary Completion
March 2, 2021
Study Completion
March 2, 2021
Last Updated
February 13, 2024
Record last verified: 2024-02