Type 2 Diabetes Mellitus Clinical Trial
— DiabOSOfficial title:
Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes: the DiabOS Study
NCT number | NCT02551315 |
Other study ID # | EKNZ 2015-117 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | January 10, 2020 |
Verified date | December 2022 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 274 |
Est. completion date | January 10, 2020 |
Est. primary completion date | January 10, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Department of Internal Medicine, University Basel, Kantonsspital | Aarau | AG |
Switzerland | Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel | Basel | |
Switzerland | Department of Internal Medicine, Kantonsspital Bruderholz | Binningen | BL |
Switzerland | Department of Internal Medicine, Kantonsspital Luzern | Luzern | LU |
Switzerland | Department of Medicine, St. Anna Hospital Hirslanden | Luzern | LU |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | University Hospital Schleswig-Holstein |
Switzerland,
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. — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Areal Bone Mineral Density (aBMD) | Areal BMD of the spine, the proximal femur and the distal radius (assessed by DXA) | 2 years | |
Secondary | bone turnover markers | alcaline phosphatase, crosslinks | 2 years | |
Secondary | advanced glycation end products (AGE) | urinary pentosidine levels | 2 years | |
Secondary | Occurence of fractures during follow up | incident fracture history | 2 years | |
Secondary | 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 | |
Secondary | 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 |
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