Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes (DenSiFy)

February 12, 2024 updated by: Claudia Gagnon, CHU de Quebec-Universite Laval

Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes (Diabetes Spine Fractures, DenSiFy)

Background : Type 1 diabetes is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. The lower bone mineral density (BMD) observed in individuals with type 1 diabetes cannot solely explain the higher fracture incidence. Bone microarchitecture defects significantly contribute to bone fragility. Few studies assessed spine fractures in type 1 diabetes.

This cross-sectional multicenter case-control study aims (1) to evaluate the prevalence of asymptomatic vertebral fractures in individuals with type 1 diabetes in comparison to age- and sex-matched healthy controls; (2) to compare individuals with diabetes with vertebral fractures and those without vertebral fracture using clinical, biochemical and radiological parameters.

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.

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.
Observational

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.
192

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

  • Canada
      • Québec, Canada, G1V 4G2
        • Centre de recherche du CHU de Québec - Université Laval
    • Quebec
      • Montréal, Quebec, Canada, H2W 1R7
        • Institut de recherches cliniques de Montréal (IRCM)

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

127 individuals with type 1 diabetes and 64 healthy subjects

Description

Individuals with type 1 diabetes

Inclusion Criteria:

  • Diagnosis of type 1 diabetes for at least 5 years;
  • Age 20 years and older.

Exclusion Criteria:

  • Pregnancy or breastfeeding;
  • Conditions associated with bone disease (significant liver disease, intestinal malabsorption other than celiac disease, organ transplant, active cancer, rheumatoid arthritis, hyperthyroidism, hypothyroidism with abnormal thyroid-stimulating hormone (TSH), hyperparathyroidism, hypoparathyroidism, acromegaly, Cushing syndrome, adrenal insufficiency);
  • Any of these medications in the past 6 months : glucocorticoids ≥ 7,5 mg prednisone/day or equivalency ≥ 3 months, aromatase inhibitors, antiandrogens, antiepileptic drugs, anticoagulants, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, thiazolidinediones;
  • Past medical history of traumatic vertebral fracture;
  • Inability to consent.

Healthy controls

Inclusion Criteria:

  • Age 20 years and older.

Exclusion Criteria:

  • As above (as individuals with diabetes), and :
  • Diagnosis of diabetes or prediabetes;
  • Celiac disease;
  • Chronic kidney disease (CrCl < 60 mL/min);
  • Any of theses medications in the past 6 months : biphosphonates, teriparatide, denosumab, calcitonin;
  • Past medical history of fragility fracture.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Healthy controls
Diagnostic test: Clinical tests
The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
Diagnostic test: Clinical tests
The investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant.
Diagnostic test: Biochemical tests
The investigators perform blood and urine tests in every participant.
Diagnostic test: DXA scan
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
Diagnostic test: AGE Reader
The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.
Individuals with type 1 diabetes
Diagnostic test: Clinical tests
The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
Diagnostic test: Clinical tests
The investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant.
Diagnostic test: Biochemical tests
The investigators perform blood and urine tests in every participant.
Diagnostic test: DXA scan
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
Diagnostic test: AGE Reader
The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine 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
Vertebral fracture detected with VFA
Time Frame: Baseline
Vertebral Fracture Assessment (VFA) software of dual-energy X-ray absorptiometry (DXA scan) is used to identify vertebral fractures. If there is evidence of a vertebral fracture on VFA, a lateral and anteroposterior spine X-ray will be obtained to confirm the VFA results.
Baseline

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: Baseline
Measured by DXA scan
Baseline
Areal bone mineral density of the spine, T-score
Time Frame: Baseline
Measured by DXA scan
Baseline
Areal bone mineral density of the spine, Z-score
Time Frame: Baseline
Measured by DXA scan
Baseline
Areal bone mineral density of proximal femur in g/cm2
Time Frame: Baseline
Measured by DXA scan
Baseline
Areal bone mineral density of proximal femur, T-score
Time Frame: Baseline
Measured by DXA scan
Baseline
Areal bone mineral density of proximal femur, Z-score
Time Frame: Baseline
Measured by DXA scan
Baseline
Areal bone mineral density of total hip in g/cm2
Time Frame: Baseline
Measured by DXA scan
Baseline
Areal bone mineral density of total hip, T-score
Time Frame: Baseline
Measured by DXA scan
Baseline
Areal bone mineral density of total hip, Z-score
Time Frame: Baseline
Measured by DXA scan
Baseline
Areal bone mineral density of distal radius in g/cm2
Time Frame: Baseline
Measured by DXA scan
Baseline
Areal bone mineral density of distal radius, T-score
Time Frame: Baseline
Measured by DXA scan
Baseline
Areal bone mineral density of distal radius, Z-score
Time Frame: Baseline
Measured by DXA scan
Baseline
Lean mass (arm, leg, trunk, android, gynoid and total)
Time Frame: Baseline
Body composition measured by DXA scan
Baseline
Fat mass (arm, leg, trunk, android, gynoid and total)
Time Frame: Baseline
Body composition measured by DXA scan
Baseline
Skin AGE measurement
Time Frame: Baseline
Measured by AGE Reader
Baseline
C-telopeptide
Time Frame: Baseline
Bone turnover marker (serum)
Baseline
Sclerostin
Time Frame: Baseline
Bone turnover marker (serum)
Baseline
Osteocalcin
Time Frame: Baseline
Bone turnover marker (serum)
Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
HbA1C
Time Frame: Baseline
Diabetes control marker
Baseline
Hemoglobin
Time Frame: Baseline
Blood level measurement
Baseline
Creatinine
Time Frame: Baseline
Blood level measurement
Baseline
Lipid panel
Time Frame: Baseline
Blood level measurement
Baseline
Thyroid-stimulating hormone (TSH)
Time Frame: Baseline
Blood level measurement
Baseline
Calcium
Time Frame: Baseline
Blood level measurement
Baseline
Albumine
Time Frame: Baseline
Blood level measurement
Baseline
Phosphate
Time Frame: Baseline
Blood level measurement
Baseline
25-Hydroxyvitamin D
Time Frame: Baseline
Blood level measurement
Baseline
Parathormone (PTH)
Time Frame: Baseline
Blood level measurement
Baseline
Insulin like growth factor-1 (IGF-1)
Time Frame: Baseline
Blood level measurement
Baseline
Antitransglutaminase antibodies
Time Frame: Baseline
Blood level measurement
Baseline
Immunoglobulin A (IgA)
Time Frame: Baseline
Blood level measurement
Baseline
Follicle stimulating hormone (FSH, women)
Time Frame: Baseline
Blood level measurement
Baseline
Total testosterone (men)
Time Frame: Baseline
Blood level measurement
Baseline
Sex hormone-binding globulin (SHBG, men)
Time Frame: Baseline
Blood level measurement
Baseline
Microalbuminuria
Time Frame: Baseline
Urine microalbuminuria / urine creatinine ratio measurement
Baseline

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.
CHU de Quebec-Universite Laval

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: Claudia Gagnon, Dr, CHU de Québec - Université Laval

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
July 29, 2019

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.
March 2, 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.
March 2, 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).
August 17, 2019

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.
August 20, 2019

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.
August 21, 2019

Study Record Updates

Last Update Posted (Estimated)

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.
February 13, 2024

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.
February 12, 2024

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.
February 1, 2024

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.
  • 2019-4550

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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