Clinical trial NCT02551315: Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes
Official title: Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes: the DiabOS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Bone Fractures
Keywords: Intra-cortical pore volume
HR-pQCT
DXA
bone mineral density
bone turnover markers
urinary pentosidine
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Hospital Schleswig-Holstein
First posted: 2015-09-16
Enrollment: 274
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intra-cortical pore volume
timeFrame: 2 years
Secondary outcomes:
measure: Areal Bone Mineral Density (aBMD)
timeFrame: 2 years
measure: bone turnover markers
timeFrame: 2 years
measure: advanced glycation end products (AGE)
timeFrame: 2 years
measure: Occurence of fractures during follow up
timeFrame: 2 years
measure: Volumetric Bone Mineral Densitiy (vBMD)
timeFrame: 2 years
measure: Cortical thickness and porosity
timeFrame: 2 years
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: University Department of Internal Medicine, University Basel, Kantonsspital
state: AG
city: Binningen
country: Switzerland
facility: Department of Internal Medicine, Kantonsspital Bruderholz
state: BL
city: Luzern
country: Switzerland
facility: Department of Internal Medicine, Kantonsspital Luzern
state: LU
city: Luzern
country: Switzerland
facility: Department of Medicine, St. Anna Hospital Hirslanden
state: LU
city: Basel
country: Switzerland
facility: Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christian Meier, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.