Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes

Study Overview
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Brief Summary
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This multicenter, prospective, observational cohort study will assess bone differences in women and men with type 2 diabetes mellitus (T2DM) with and without fragility fractures.

Detailed Description
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Cross-sectional evaluation of clinical, biochemical and microstructural measures of bone in patients with type 2 diabetes and age-matched healthy controls. Longitudinal assessment of clinical, biochemical and microstructural measures of bone in study participants without prevalent fragility fractures.

Official Title
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Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes: the DiabOS Study

Conditions
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Type 2 Diabetes Mellitus, Bone Fractures

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - presence of type 2 diabetes for at least 3 years (history of treatment for type 2 diabetes) Exclusion Criteria: immobility coexisting metabolic bone disease or comorbidities affecting bone health previous treatment with osteoporosis medication or intake of medications known to affect bone metabolism (e.g. steroids) within 6 months prior to enrolment thiazolidinedione use

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetics, no fractures<br>Postmenopausal women and men with T2DM, without prevalent fragility fractures (longitudinal follow-up) | |
| Type 2 diabetics, prevalent fractures<br>Postmenopausal women and men with T2DM, with prevalent fragility fractures | |
| Controls, no fractures<br>Age and sex-matched non-diabetic controls, without fragility fractures (longitudinal follow-up) | |
| Controls, prevalent fractures<br>Age and sex-matched non-diabetic controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-cortical pore volume | Intracortical pore volume using HR-QCT femoral shaft and mid-tibia and HR-pQCT at the distal radius (mm3) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Areal Bone Mineral Density (aBMD) | Areal BMD of the spine, the proximal femur and the distal radius (assessed by DXA) | 2 years | 
| bone turnover markers | alcaline phosphatase, crosslinks | 2 years | 
| advanced glycation end products (AGE) | urinary pentosidine levels | 2 years | 
| Occurence of fractures during follow up | incident fracture history | 2 years | 
| Volumetric Bone Mineral Densitiy (vBMD) | vBMD of the proximal femur, including trabecular and cortical bone in the femoral neck and Trochanter (assessed by HR-QCT) | 2 years | 
| Cortical thickness and porosity | assessed by HR-QCT at the caudal Region of the femoral neck or the proximal third of the femoral shaft | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intra-cortical pore volume, HR-pQCT, DXA, bone mineral density, bone turnover markers, urinary pentosidine