Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes (Diabetes Spine Fractures, DenSiFy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Vertebral fracture detected with VFA
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of type 1 diabetes for at least 5 years;
- •Age 20 years and older.
排除标准
- •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.
结局指标
主要结局
Vertebral fracture detected with VFA
时间窗: 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.
次要结局
- Areal bone mineral density of proximal femur, T-score(Baseline)
- C-telopeptide(Baseline)
- Sclerostin(Baseline)
- Areal bone mineral density of total hip in g/cm2(Baseline)
- 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, Z-score(Baseline)
- Areal bone mineral density of total hip, Z-score(Baseline)
- Areal bone mineral density of proximal femur in g/cm2(Baseline)
- Areal bone mineral density of distal radius in g/cm2(Baseline)
- Skin AGE measurement(Baseline)
- Areal bone mineral density of total hip, T-score(Baseline)
- Areal bone mineral density of distal radius, T-score(Baseline)
- Areal bone mineral density of distal radius, Z-score(Baseline)
- Lean mass (arm, leg, trunk, android, gynoid and total)(Baseline)
- Fat mass (arm, leg, trunk, android, gynoid and total)(Baseline)
- Osteocalcin(Baseline)
研究者
Claudia Gagnon
MD
CHU de Quebec-Universite Laval