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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Unknown status

CT.gov ID

NCT02551315

Collaborator

University Hospital Schleswig-Holstein (Other)

440

Enrollment

Locations

Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Bone 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 Design

Study Type:

Observational

Anticipated Enrollment :

440 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Type 2 diabetics, no fractures Postmenopausal women and men with T2DM, without prevalent fragility fractures (longitudinal follow-up)
Type 2 diabetics, prevalent fractures Postmenopausal women and men with T2DM, with prevalent fragility fractures
Controls, no fractures Age and sex-matched non-diabetic controls, without fragility fractures (longitudinal follow-up)
Controls, prevalent fractures Age and sex-matched non-diabetic controls

Outcome Measures

Primary Outcome Measures

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

Areal Bone Mineral Density (aBMD) [2 years]
Areal BMD of the spine, the proximal femur and the distal radius (assessed by DXA)
bone turnover markers [2 years]
alcaline phosphatase, crosslinks
advanced glycation end products (AGE) [2 years]
urinary pentosidine levels
Occurence of fractures during follow up [2 years]
incident fracture history
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Department of Internal Medicine, University Basel, Kantonsspital	Aarau	AG	Switzerland	5001
2	Department of Internal Medicine, Kantonsspital Bruderholz	Binningen	BL	Switzerland	4101
3	Department of Internal Medicine, Kantonsspital Luzern	Luzern	LU	Switzerland	6000
4	Department of Medicine, St. Anna Hospital Hirslanden	Luzern	LU	Switzerland	6006
5	Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel	Basel		Switzerland	4031