Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes

Completed

• Conditions: Bone Fractures; Type 2 Diabetes Mellitus

• Registration Number: NCT02551315
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-09-14
• Study First Posted: 2015-09-16
• Study Start: 2016-06
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intra-cortical pore volume	2 years	Intracortical pore volume using HR-QCT femoral shaft and mid-tibia and HR-pQCT at the distal radius (mm3)

Secondary Outcome Measures

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

Trial Locations

Locations (5)

University Department of Internal Medicine, University Basel, Kantonsspital; 🇨🇭 Aarau, AG, 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, Switzerland

Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel; 🇨🇭 Basel, Switzerland