Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes

NCT ID: NCT02551315

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

274 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-01-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Bone Fractures

Keywords

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Intra-cortical pore volume HR-pQCT DXA bone mineral density bone turnover markers urinary pentosidine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Type 2 diabetics, no fractures

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

No interventions assigned to this group

Type 2 diabetics, prevalent fractures

Postmenopausal women and men with T2DM, with prevalent fragility fractures

No interventions assigned to this group

Controls, no fractures

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

No interventions assigned to this group

Controls, prevalent fractures

Age and sex-matched non-diabetic controls

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Christian Meier

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Meier, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Department of Internal Medicine, Kantonsspital Bruderholz

Binningen, Basel-Landschaft, Switzerland

Site Status

University Department of Internal Medicine, University Basel, Kantonsspital

Aarau, Canton of Aargau, Switzerland

Site Status

Department of Internal Medicine, Kantonsspital Luzern

Lucerne, Canton of Lucerne, Switzerland

Site Status

Department of Medicine, St. Anna Hospital Hirslanden

Lucerne, Canton of Lucerne, Switzerland

Site Status

Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 35094426 (View on PubMed)

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.

Reference Type RESULT
PMID: 36190530 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39777548 (View on PubMed)

Other Identifiers

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EKNZ 2015-117

Identifier Type: -

Identifier Source: org_study_id