Microarchitecture, Bone Strength and Fracture Risk in Long-term Type 1 Diabetes (BOLD-1)

July 24, 2021 updated by: Christian Meier
This single center case control study will assess differences in bone structure between women and men with longstanding type 1 diabetes (diabetes duration>/= 25 years) and healthy controls.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Based on a cross-sectional approach the investigators aim to assess microstructural, biomechanical and densitometric bone characteristics in patients with longstanding type 1 diabetes and age- and sex-matches controls. The investigators examine whether the presence of microvascular disease and/or poor diabetic control is associated with an altered bone microarchitecture and whether any such effect is independent of bone mineral density. Furthermore, the investigators aim to look into the relationship between an altered bone microarchitecture and advanced glycation end product (AGE) formation as well as biochemical markers of bone formation and bone turnover. The study aims to identify type 1 diabetic patients with high fracture risk by assessing the discriminatory power of parameters of cortical and trabecular microstructure measured via high resolution peripheral quantitative computed tomography (HR-pQCT) of the distal radius and tibia and high resolution quantitative computed tomography (HR-QCT) of the proximal femur and tibia with and without adjustment for bone density.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Stadt
      • Basel, Basel Stadt, Switzerland, 4031
        • Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • women and men with longstanding type 1 diabetes (age 40-80 years, BMI 18-37 kg/m2 and age- and sex matched non-diabetic controls
  • presence of type 1 diabetes for at least 25 years (defined by history of Insulin treatment)

Exclusion Criteria:

  • Patients unable to give written informed consent, e.g. with severe dementia or patients not understanding German (or other local language)
  • Any medical or psychiatric condition which would preclude the participant from adhering to the protocol
  • Idiopathic or premenopausal osteoporosis or coexisting metabolic bone disease (e.g. Paget´s disease, primary hyperparathyroidism)
  • Previous treatment with osteoporosis medication (bisphosphonates, denosumab) or intake of medications that are known to affect bone metabolism (e.g. steroids, anticonvulsants) within 6 months prior to enrollment
  • Patients with medical conditions known to affect bone health ( e.g. metastatic bone disease, celiac disease, inflammatory bone disease, hypogonadism, thyrotoxicosis, hypercortisolism, chronic kidney disease stage IV and V (KDIGO), liver dysfunction (serum aspartate amino transferase (ASAT) >3 times the upper limit of normal)
  • Inability to keep the extremities still for a few minutes of an HR-pQCT examination (e.g. Parkinson disease, spastic syndrome)
  • Pregnant or breastfeeding women

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Diagnostic
The investigators will examine all participants in the same way by performing biochemical tests, clinical tests, osteodensitometry, HRQCT and HRpQCT measurements.
Diagnostic test: Biochemical Tests
The investigators will perform blood tests in every participant.
Diagnostic test: Osteodensitometry
The investigators will perform an osteodensitometry in every participant.
Other Names:
  • dual energy x-ray absorptiometry (DXA scan)
Diagnostic test: Clinical Tests
The investigators perform the following clinical tests: vibration threshold test, monofilament test, chair rise test and timed up and go test in every participant.
Diagnostic test: HR-QCT
The investigators will perform HR-QCT measurements of the proximal femur and tibia in every participant.
Diagnostic test: HR-pQCT
The investigators will perform HR-pQCT measurements of the distal radius and distal tibia in every participant.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
volumetric bone mineral density in mg hydroxyapatite (HA)/ccm
Time Frame: through study completion, an average of 6 months
measured by HR-pQCT at the distal radius and tibia
through study completion, an average of 6 months
cortical porosity in %
Time Frame: through study completion, an average of 6 months
measured by HR-pQCT at the distal radius and tibia
through study completion, an average of 6 months
bone stiffness in kilonewton (kN)/mm
Time Frame: through study completion, an average of 6 months
a measure of bone strength, measured by HR-pQCT at the distal radius and tibia
through study completion, an average of 6 months
failure load in kN
Time Frame: through study completion, an average of 6 months
a measure of bone strength, measured by HR-pQCT at the distal radius and tibia
through study completion, an average of 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
areal bone mineral density of the spine in g/cm2
Time Frame: through study completion, an average of 6 months
measured by osteodensitometry (DXA)
through study completion, an average of 6 months
areal bone mineral density of the proximal femur in g/cm2
Time Frame: through study completion, an average of 6 months
measured by osteodensitometry
through study completion, an average of 6 months
areal bone mineral density of the distal radius in g/cm2
Time Frame: through study completion, an average of 6 months
measured by osteodensitometry
through study completion, an average of 6 months
trabecular bone score of the spine
Time Frame: through study completion, an average of 6 months
a measure of bone texture, measured by osteodensitometry
through study completion, an average of 6 months
cortical thickness at the mid tibia in cm
Time Frame: through study completion, an average of 6 months
the cortical thickness will be measured by pulse-echo ultrasound and high resolution quantitative computed tomography (HR-QCT)
through study completion, an average of 6 months
density weighed cortical thickness at the mid tibia in cm
Time Frame: through study completion, an average of 6 months
the density weighed cortical thickness will be measured by pulse-echo ultrasound and HR- QCT
through study completion, an average of 6 months
bone marrow adiposity in mg/cm3
Time Frame: through study completion, an average of 6 months
measured by HR-pQCT
through study completion, an average of 6 months
measurement of serum carboxy-terminal collagen crosslinks (CTX) in pg/ml
Time Frame: through study completion, an average of 6 months
biochemical marker of bone resorption
through study completion, an average of 6 months
measurement of serum n-terminal procollagen type 1 (P1NP) in mcg/l
Time Frame: through study completion, an average of 6 months
biochemical marker of bone formation
through study completion, an average of 6 months
measurement of serum pentosidine in pmol/m
Time Frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
through study completion, an average of 6 months
measurement of serum carboxymethyl-lysine (CML) in pmol/ml
Time Frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
through study completion, an average of 6 months
measurement of serum insulin in mU/ml
Time Frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
through study completion, an average of 6 months
measurement of serum sclerostin in pg/ml
Time Frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
through study completion, an average of 6 months
measurement of serum adiponectin in ng/ml
Time Frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
through study completion, an average of 6 months
measurement of serum insulin like growth factor -1 (IGF1) in nM
Time Frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
through study completion, an average of 6 months
measurement of serum ultrasensitive c-reactive protein (usCRP) in mg/l
Time Frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
through study completion, an average of 6 months
measurement of serum interleukin 6 (IL6) in pg/ml
Time Frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
through study completion, an average of 6 months
measurement of serum periostin in ng/ml
Time Frame: through study completion, an average of 6 months
biochemical marker associated with bone fragility
through study completion, an average of 6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Christian Meier

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital Inselspital, Berne
University Hospital, Basel, Switzerland
University Hospital Schleswig-Holstein

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian Meier, Prof., University Hospital, Basel, Switzerland

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EKNZ 2018-01517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

In the informed consent document participants can choose whether they agree to the further use of their coded data and biochemical material for future research purposes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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