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

December 20, 2022 updated by: Christian Meier, University Hospital, Basel, Switzerland

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

274

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel
    • AG
      • Aarau, AG, Switzerland, 5001
        • University Department of Internal Medicine, University Basel, Kantonsspital
    • BL
      • Binningen, BL, Switzerland, 4101
        • Department of Internal Medicine, Kantonsspital Bruderholz
    • LU
      • Luzern, LU, Switzerland, 6000
        • Department of Internal Medicine, Kantonsspital Luzern
      • Luzern, LU, Switzerland, 6006
        • Department of Medicine, St. Anna Hospital Hirslanden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Female and male diabetics (aged between 50 and 75 years; BMI between 18 and 37 kg/m2) Age- and sex-matched non-diabetic controls

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Christian Meier, Prof. MD, University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

January 10, 2020

Study Completion (Actual)

January 10, 2020

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

September 14, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Actual)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 20, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKNZ 2015-117

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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