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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2022
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland University Hospital Schleswig-Holstein

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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

Outcome

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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