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NCT Number: NCT02551315

Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Bone Fractures Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Fractures, Bone Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Wounds and Injuries

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Internal Medicine, Kantonsspital Bruderholz, Binningen, Basel-Landschaft, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intra-cortical pore volume

    Time frame: 2 years

    Intracortical pore volume using HR-QCT femoral shaft and mid-tibia and HR-pQCT at the distal radius (mm3)

Secondary outcomes

  1. Areal Bone Mineral Density (aBMD)

    Time frame: 2 years

    Areal BMD of the spine, the proximal femur and the distal radius (assessed by DXA)

  2. bone turnover markers

    Time frame: 2 years

    alcaline phosphatase, crosslinks

  3. advanced glycation end products (AGE)

    Time frame: 2 years

    urinary pentosidine levels

  4. Occurence of fractures during follow up

    Time frame: 2 years

    incident fracture history

  5. Volumetric Bone Mineral Densitiy (vBMD)

    Time frame: 2 years

    vBMD of the proximal femur, including trabecular and cortical bone in the femoral neck and Trochanter (assessed by HR-QCT)

  6. Cortical thickness and porosity

    Time frame: 2 years

    assessed by HR-QCT at the caudal Region of the femoral neck or the proximal third of the femoral shaft

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • University Hospital Schleswig-Holstein

Registry information

Official study title

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

Acronym: DiabOS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2015
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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