Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes (DiabOS)

University Hospital Basel

Status: Completed

Conditions: Type 2 Diabetes Mellitus; Bone Fractures

Study type: Observational

Funder types: Other

Identifiers

NCT02551315

EKNZ 2015-117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 274 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

274 participants in 4 patient groups

Type 2 diabetics, no fractures

Description:

Postmenopausal women and men with T2DM, without prevalent fragility fractures (longitudinal follow-up)

Type 2 diabetics, prevalent fractures

Description:

Postmenopausal women and men with T2DM, with prevalent fragility fractures

Controls, no fractures

Description:

Age and sex-matched non-diabetic controls, without fragility fractures (longitudinal follow-up)

Controls, prevalent fractures

Description:

Age and sex-matched non-diabetic controls