NCT02551315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 16, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2020

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

3.6 years

First QC Date

August 25, 2015

Last Update Submit

December 20, 2022

Conditions

Type 2 Diabetes MellitusBone Fractures

Keywords

Intra-cortical pore volumeHR-pQCTDXAbone mineral densitybone turnover markersurinary pentosidine

Outcome Measures

Primary Outcomes (1)

  • Intra-cortical pore volume

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

    2 years

Secondary Outcomes (6)

  • Areal Bone Mineral Density (aBMD)

    2 years

  • bone turnover markers

    2 years

  • advanced glycation end products (AGE)

    2 years

  • Occurence of fractures during follow up

    2 years

  • Volumetric Bone Mineral Densitiy (vBMD)

    2 years

  • +1 more secondary outcomes

Study Arms (4)

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

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • \- presence of type 2 diabetes for at least 3 years (history of treatment for type 2 diabetes)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Internal Medicine, Kantonsspital Bruderholz

Binningen, Basel-Landschaft, 4101, Switzerland

Location

University Department of Internal Medicine, University Basel, Kantonsspital

Aarau, Canton of Aargau, 5001, Switzerland

Location

Department of Internal Medicine, Kantonsspital Luzern

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Department of Medicine, St. Anna Hospital Hirslanden

Lucerne, Canton of Lucerne, 6006, Switzerland

Location

Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (3)

  • Sewing L, Potasso L, Baumann S, Schenk D, Gazozcu F, Lippuner K, Kraenzlin M, Zysset P, Meier C. Bone Microarchitecture and Strength in Long-Standing Type 1 Diabetes. J Bone Miner Res. 2022 May;37(5):837-847. doi: 10.1002/jbmr.4517. Epub 2022 Mar 8.

    PMID: 35094426RESULT

  • Vavanikunnel J, Sewing L, Triantafyllidou M, Steighardt A, Baumann S, Egger A, Grize L, Felix B, Kraenzlin M, Henzen C, Meier C. Determinants of Low Bone Turnover in Type 2 Diabetes-the Role of PTH. Calcif Tissue Int. 2022 Dec;111(6):587-596. doi: 10.1007/s00223-022-01022-7. Epub 2022 Oct 3.

    PMID: 36190530RESULT

  • Baumann S, Sewing L, Traechslin C, Verhagen-Kamerbeek W, Grize L, Kraenzlin M, Meier C. Serum Pentosidine in Relation to Obesity in Patients with Type 2 Diabetes and Healthy Controls. Calcif Tissue Int. 2025 Jan 7;116(1):25. doi: 10.1007/s00223-024-01338-6.

    PMID: 39777548DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bone trunover markers, parameters re calcium metabolism, HbA1c, Insulin, pentosidine, markers of inflammation

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Fractures, Bone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesWounds and Injuries

Study Officials

  • Christian Meier, Prof. MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

August 25, 2015

First Posted

September 16, 2015

Study Start

June 1, 2016

Primary Completion

January 10, 2020

Study Completion

January 10, 2020

Last Updated

December 22, 2022

Record last verified: 2022-12

Locations

CH(5)