Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02551315

Acronym

DiabOS

Enrollment

274

Registered

2015-09-16

Start date

2016-06-30

Completion date

2020-01-10

Last updated

2022-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Fractures, Type 2 Diabetes Mellitus

Keywords

Intra-cortical pore volume, HR-pQCT, DXA, bone mineral density, bone turnover markers, urinary pentosidine

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
bone turnover markers	2 years	alcaline phosphatase, crosslinks
advanced glycation end products (AGE)	2 years	urinary pentosidine levels
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)
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
Occurence of fractures during follow up	2 years	incident fracture history

Countries

Switzerland

Outcome results