Type 2 Diabetes MellitusDiabOSNCT02551315
Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus and Bone Fractures, run by University Hospital, Basel, Switzerland at 5 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Bone Fractures
- How many people
- 274 participants
- Where
- 5 sitesSwitzerland
- Study dates
- Jun 2016to 10 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- presence of type 2 diabetes for at least 3 years (history of treatment for type 2 diabetes)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Switzerland5 sites
University Department of Internal Medicine, University Basel, Kantonsspital
Aarau, Canton of Aargau, 5001
Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel
Basel, 4031
Department of Internal Medicine, Kantonsspital Bruderholz
Binningen, Basel-Landschaft, 4101
Department of Internal Medicine, Kantonsspital Luzern
Lucerne, Canton of Lucerne, 6000
Department of Medicine, St. Anna Hospital Hirslanden
Lucerne, Canton of Lucerne, 6006
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Bone Fractures
- Keywords
- Intra-cortical pore volume, HR-pQCT, DXA, bone mineral density, bone turnover markers, urinary pentosidine
- Medical subject headings
- Diabetes Mellitus, Type 2, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Intra-cortical pore volume
Intracortical pore volume using HR-QCT femoral shaft and mid-tibia and HR-pQCT at the distal radius (mm3)
Measured: 2 years
Secondary outcomes (6)
Areal Bone Mineral Density (aBMD)
Areal BMD of the spine, the proximal femur and the distal radius (assessed by DXA)
Measured: 2 years
bone turnover markers
alcaline phosphatase, crosslinks
Measured: 2 years
advanced glycation end products (AGE)
urinary pentosidine levels
Measured: 2 years
Occurence of fractures during follow up
incident fracture history
Measured: 2 years
Volumetric Bone Mineral Densitiy (vBMD)
vBMD of the proximal femur, including trabecular and cortical bone in the femoral neck and Trochanter (assessed by HR-QCT)
Measured: 2 years
Cortical thickness and porosity
assessed by HR-QCT at the caudal Region of the femoral neck or the proximal third of the femoral shaft
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startJun 2016
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein
- Responsible party
- Principal investigator, Christian Meier, University Hospital, Basel, Switzerland
- Investigators
- Christian Meier, Prof. MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551315
- Sponsor's protocol ID
- EKNZ 2015-117
- Acronym
- DiabOS
- Status last verified
- Dec 2022
- First submitted
- 25 Aug 2015
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 35094426Vavanikunnel 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.
PubMed 36190530Baumann 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.
PubMed 39777548
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microarchitecture, Bone Strength and Fracture Risk in Type 2 Diabetes: the DiabOS Study
- ClinicalTrials.gov ID
- NCT02551315
- Acronym / sponsor ID
- DiabOS / EKNZ 2015-117
- Conditions
- Type 2 Diabetes Mellitus, Bone Fractures
- Keywords
- Intra-cortical pore volume, HR-pQCT, DXA, bone mineral density, bone turnover markers, urinary pentosidine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Hospital Schleswig-Holstein
- Study start
- Jun 2016
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- presence of type 2 diabetes for at least 3 years (history of treatment for type 2 diabetes)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
6 secondary outcomes
Areal Bone Mineral Density (aBMD)
Time frame: 2 years
bone turnover markers
Time frame: 2 years
advanced glycation end products (AGE)
Time frame: 2 years
Occurence of fractures during follow up
Time frame: 2 years
Volumetric Bone Mineral Densitiy (vBMD)
Time frame: 2 years
Cortical thickness and porosity
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Results publication: PubMed 35094426Sewing 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.
- Results publication: PubMed 36190530Vavanikunnel 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.
- Derived from this study: PubMed 39777548Baumann 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Meier, Prof. MD principal investigator
University Hospital, Basel, Switzerland
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Bone Fractures, run by University Hospital, Basel, Switzerland at 5 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-cortical pore volume (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02551315, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.