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| Name | Class |
|---|---|
| University Hospital Schleswig-Holstein | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetics, no fractures | Postmenopausal women and men with T2DM, without prevalent fragility fractures (longitudinal follow-up) | ||
| Type 2 diabetics, prevalent fractures | Postmenopausal women and men with T2DM, with prevalent fragility fractures | ||
| Controls, no fractures | Age and sex-matched non-diabetic controls, without fragility fractures (longitudinal follow-up) | ||
| Controls, prevalent fractures | Age and sex-matched non-diabetic controls |
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| 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 |
| 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 |
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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:
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Female and male diabetics (aged between 50 and 75 years; BMI between 18 and 37 kg/m2) Age- and sex-matched non-diabetic controls
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| Name | Affiliation | Role |
|---|---|---|
| Christian Meier, Prof. MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Kantonsspital Bruderholz | Binningen | Basel-Landschaft | 4101 | Switzerland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35094426 | Result | Sewing L, Potasso L, Baumann S, Schenk D, Gazozcu F, Lippuner K, Kraenzlin M, Zysset P, Meier C. Bone Microarchitecture and Strength in Long-Standing Type 1 Diabetes. J Bone Miner Res. 2022 May;37(5):837-847. doi: 10.1002/jbmr.4517. Epub 2022 Mar 8. | |
| 36190530 | Result | Vavanikunnel J, Sewing L, Triantafyllidou M, Steighardt A, Baumann S, Egger A, Grize L, Felix B, Kraenzlin M, Henzen C, Meier C. Determinants of Low Bone Turnover in Type 2 Diabetes-the Role of PTH. Calcif Tissue Int. 2022 Dec;111(6):587-596. doi: 10.1007/s00223-022-01022-7. Epub 2022 Oct 3. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Bone trunover markers, parameters re calcium metabolism, HbA1c, Insulin, pentosidine, markers of inflammation
| 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 |
| University Department of Internal Medicine, University Basel, Kantonsspital |
| Aarau |
| Canton of Aargau |
| 5001 |
| Switzerland |
| Department of Internal Medicine, Kantonsspital Luzern | Lucerne | Canton of Lucerne | 6000 | Switzerland |
| Department of Medicine, St. Anna Hospital Hirslanden | Lucerne | Canton of Lucerne | 6006 | Switzerland |
| Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel | Basel | 4031 | Switzerland |
| 39777548 | Derived | Baumann S, Sewing L, Traechslin C, Verhagen-Kamerbeek W, Grize L, Kraenzlin M, Meier C. Serum Pentosidine in Relation to Obesity in Patients with Type 2 Diabetes and Healthy Controls. Calcif Tissue Int. 2025 Jan 7;116(1):25. doi: 10.1007/s00223-024-01338-6. |
| D004700 | Endocrine System Diseases |
| D014947 | Wounds and Injuries |