Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

— DiabOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551315
• Other study ID #: EKNZ 2015-117
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Bone Fractures
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fractures, Bone
• Type 2 Diabetes Mellitus

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