Diabetes Mellitus, Type 1DenSiFyNCT04064437
Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes
An observational study of Diabetes Mellitus, Type 1 and Bone Fracture, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Bone Fracture, Bone Health
- What is being tested?
- Clinical tests, Biochemical tests and DXA scan
- How many people
- 192 participants
- Where
- 2 sitesCanada
- Study dates
- 29 Jul 2019to 2 Mar 2021
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 127 individuals with type 1 diabetes and 64 healthy subjects
Who may be able to join
- Diagnosis of type 1 diabetes for at least 5 years;
- Age 20 years and older.
- Age 20 years and older.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institut de recherches cliniques de Montréal (IRCM)
Montreal, Quebec, H2W 1R7
Centre de recherche du CHU de Québec - Université Laval
Québec, G1V 4G2
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type 1, Bone Fracture, Bone Health
- Being tested
- Clinical tests, Biochemical tests, DXA scan, AGE Reader
- Medical subject headings
- Diabetes Mellitus, Type 1, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical testsDiagnostic test
The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
Clinical testsDiagnostic test
The investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant.
Biochemical testsDiagnostic test
The investigators perform blood and urine tests in every participant.
DXA scanDiagnostic test
The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
AGE ReaderDiagnostic test
The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with type 1 diabetes | Not described Receives: Diagnostic Test: Clinical tests; Diagnostic Test: Biochemical tests; Diagnostic Test: DXA scan; Diagnostic Test: AGE Reader | |
| Healthy controls | Not described Receives: Diagnostic Test: Clinical tests; Diagnostic Test: Biochemical tests; Diagnostic Test: DXA scan; Diagnostic Test: AGE Reader |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertebral fracture detected with VFA
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.
Measured: Baseline
Secondary outcomes (18)
Areal bone mineral density of the spine in g/cm2
Measured by DXA scan
Measured: Baseline
Areal bone mineral density of the spine, T-score
Measured by DXA scan
Measured: Baseline
Areal bone mineral density of the spine, Z-score
Measured by DXA scan
Measured: Baseline
Areal bone mineral density of proximal femur in g/cm2
Measured by DXA scan
Measured: Baseline
Areal bone mineral density of proximal femur, T-score
Measured by DXA scan
Measured: Baseline
Areal bone mineral density of proximal femur, Z-score
Measured by DXA scan
Measured: Baseline
Areal bone mineral density of total hip in g/cm2
Measured by DXA scan
Measured: Baseline
Areal bone mineral density of total hip, T-score
Measured by DXA scan
Measured: Baseline
Areal bone mineral density of total hip, Z-score
Measured by DXA scan
Measured: Baseline
Areal bone mineral density of distal radius in g/cm2
Measured by DXA scan
Measured: Baseline
Areal bone mineral density of distal radius, T-score
Measured by DXA scan
Measured: Baseline
Areal bone mineral density of distal radius, Z-score
Measured by DXA scan
Measured: Baseline
Lean mass (arm, leg, trunk, android, gynoid and total)
Body composition measured by DXA scan
Measured: Baseline
Fat mass (arm, leg, trunk, android, gynoid and total)
Body composition measured by DXA scan
Measured: Baseline
Skin AGE measurement
Measured by AGE Reader
Measured: Baseline
C-telopeptide
Bone turnover marker (serum)
Measured: Baseline
Sclerostin
Bone turnover marker (serum)
Measured: Baseline
Osteocalcin
Bone turnover marker (serum)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start29 Jul 2019
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Gagnon, CHU de Quebec-Universite Laval
- Investigators
- Claudia Gagnon, Dr, Principal investigator, CHU de Québec - Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064437
- Sponsor's protocol ID
- 2019-4550
- Acronym
- DenSiFy
- Status last verified
- Feb 2024
- First submitted
- 17 Aug 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coll JC, Garceau E, Leslie WD, Genest M, Michou L, Weisnagel SJ, Mac-Way F, Albert C, Morin SN, Rabasa-Lhoret R, Gagnon C. Prevalence of Vertebral Fractures in Adults With Type 1 Diabetes: DenSiFy Study (Diabetes Spine Fractures). J Clin Endocrinol Metab. 2022 Apr 19;107(5):e1860-e1870. doi: 10.1210/clinem/dgac031.
PubMed 35090169
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Vertebral Fractures in Patients With Type 1 Diabetes (Diabetes Spine Fractures, DenSiFy)
- ClinicalTrials.gov ID
- NCT04064437
- Acronym / sponsor ID
- DenSiFy / 2019-4550
- Conditions
- Diabetes Mellitus, Type 1, Bone Fracture, Bone Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 21 Aug 2019 (actual)
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals with type 1 diabetes | – | Diagnostic Test: Clinical tests, Diagnostic Test: Biochemical tests, Diagnostic Test: DXA scan, Diagnostic Test: AGE Reader |
| Healthy controls | – | Diagnostic Test: Clinical tests, Diagnostic Test: Biochemical tests, Diagnostic Test: DXA scan, Diagnostic Test: AGE Reader |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 127 individuals with type 1 diabetes and 64 healthy subjects
Key inclusion criteria (3 listed)
- Diagnosis of type 1 diabetes for at least 5 years;
- Age 20 years and older.
- Age 20 years and older.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical testsThe investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant. | Diagnostic test | Individuals with type 1 diabetes |
| Clinical testsThe investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant. | Diagnostic test | Healthy controls |
| Biochemical testsThe investigators perform blood and urine tests in every participant. | Diagnostic test | Healthy controls, Individuals with type 1 diabetes |
| DXA scanThe investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant. | Diagnostic test | Healthy controls, Individuals with type 1 diabetes |
| AGE ReaderThe investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant. | Diagnostic test | Healthy controls, Individuals with type 1 diabetes |
Primary outcome
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.
18 secondary outcomes
Areal bone mineral density of the spine in g/cm2
Time frame: Baseline
Areal bone mineral density of the spine, T-score
Time frame: Baseline
Areal bone mineral density of the spine, Z-score
Time frame: Baseline
Areal bone mineral density of proximal femur in g/cm2
Time frame: Baseline
Areal bone mineral density of proximal femur, T-score
Time frame: Baseline
Areal bone mineral density of proximal femur, Z-score
Time frame: Baseline
Areal bone mineral density of total hip in g/cm2
Time frame: Baseline
Areal bone mineral density of total hip, T-score
Time frame: Baseline
Areal bone mineral density of total hip, Z-score
Time frame: Baseline
Areal bone mineral density of distal radius in g/cm2
Time frame: Baseline
Areal bone mineral density of distal radius, T-score
Time frame: Baseline
Areal bone mineral density of distal radius, Z-score
Time frame: Baseline
Lean mass (arm, leg, trunk, android, gynoid and total)
Time frame: Baseline
Fat mass (arm, leg, trunk, android, gynoid and total)
Time frame: Baseline
Skin AGE measurement
Time frame: Baseline
C-telopeptide
Time frame: Baseline
Sclerostin
Time frame: Baseline
Osteocalcin
Time frame: Baseline
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 13 Feb 2024.
- Results publication: PubMed 35090169Coll JC, Garceau E, Leslie WD, Genest M, Michou L, Weisnagel SJ, Mac-Way F, Albert C, Morin SN, Rabasa-Lhoret R, Gagnon C. Prevalence of Vertebral Fractures in Adults With Type 1 Diabetes: DenSiFy Study (Diabetes Spine Fractures). J Clin Endocrinol Metab. 2022 Apr 19;107(5):e1860-e1870. doi: 10.1210/clinem/dgac031.
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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.
Claudia Gagnon, Dr principal investigator
CHU de Québec - Université Laval
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Bone Fracture, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
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 3 inclusion and 12 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Vertebral fracture detected with VFA (time frame: Baseline). 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 NCT04064437, which also lists 1 linked publication.
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 13 Feb 2024.