- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06287840
Canadian Bone Strength Development Study (CanBSDS)
Canadian Bone Strength Development in Children With Type 1 Diabetes Study
The goal of this project is to learn about differences in bone development between children with and without type-1 diabetes (T1D). The main questions this study aims to answer are:
- Assess how and when sex-specific bone developmental trajectories in the leg and arm will differ between children with T1D and control cohorts relative to the critical period of rapid skeletal growth in puberty. It is hypothesized that children with T1D will have inferior bone development, particularly lower gains in bone strength.
- Assess why bone trajectories differ between T1D and control cohorts by identifying the role of body composition, site-specific muscle force and physical activity on differences in bone properties in female and male children with and without T1D. It is hypothesized that children with T1D will have lower gains in lean mass, muscle force, number of daily bone impacts and minutes of moderate-vigorous physical activity and will be associated with inferior gains in bone development.
- Assess why T1D may impair sex-specific bone development by exploring the role of disease-related factors (e.g., duration, glucose control, hormones and markers of bone turnover) and fracture history on bone trajectories of children with T1D. It is hypothesized that longer exposure to T1D, poorer glucose control, alterations in hormones, lower bone formation markers and higher history of fracture will be negatively associated with bone trajectories of children with T1D.
Participant's physical growth, bone growth, muscle strength, physical activity and nutrition habits will be assessed and followed up annually for up to 4 years.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Saija Kontulainen, PhD
- Phone Number: (306)966-1077
- Email: saija.kontulainen@usask.ca
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N5B2
- Recruiting
- University of Saskatchewan
-
Contact:
- Saija Kontulainen, PhD
- Phone Number: (306)966-1077
- Email: saija.kontulainen@usask.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Children with Type-I Diabetes:
Inclusion Criteria
- Females: 10-11 years old.
- Males: 11 - 12 years old.
- Diagnosed with type-1 diabetes for at least 6 months.
- Capacity to give informed consent (patient and parent/guardian). Children with the capacity to give assent will do so in addition to parental consent.
Exclusion Criteria
- Consuming any medications or have additional illnesses associated with bone health, osteoporosis (including renal disease, celiac disease, hypogonadism, hyperthyroidism) or altered physical growth (precocious puberty).
- Have gone through adolescent growth spurt at study entry.
Control Group (Typically Developing Children):
Inclusion Criteria
- Females: 10-11 years old.
- Males: 11 - 12 years old.
- Capacity to give informed consent (patient and parent/guardian). Children with the capacity to give assent will do so in addition to parental consent.
Exclusion Criteria
- Have an illness or are taking medications influencing bone health or physical growth.
- Evidence of pathologic low trauma or vertebral fracture(s).
- Have gone through adolescent growth spurt at study entry.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Children with Type-1 Diabetes
|
Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trabecular Thickness (μm)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Bone Strength (Failure load)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total, Cortical and Trabecular Bone Area (mm^2)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Total, Cortical and Trabecular Bone Density (mg HA/cm^3)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Cortical Thickness (μm)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Cortical Porosity
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Trabecular Bone Volume Fraction (%)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Trabecular Bone Number (1/mm)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Trabecular Bone Separation (μm)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Total Body and Hip Bone Mineral Content (g)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Assessed by Dual-energy X-ray absorptiometry (DXA).
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Total Body and Hip Areal Bone Mineral Density (g/cm^2)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Assessed by Dual-energy X-ray absorptiometry (DXA).
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Age from Peak Height Velocity (years)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Body mass, height and sitting height will be used to estimate age from peak height velocity.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Pubertal Development
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Pubertal development will be determined using Tanner Stages (self-assessed).
Participants will be asked to look at drawings of pubic hair and genital or breast development and rate what drawing best reflects their current stage of development.
Each set of drawings is associated with a pubertal stage (1-5).
Stage 1 indicates pre-pubertal status, stage 2-3 indicates early pubertal status, stage 4 indicates pubertal status and stage 5 indicates post-pubertal status.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Long Jump (m)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
The furthest distance an individual can jump while starting from a standing position.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Hand Grip (N)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
The highest amount of force one can develop by squeezing their hand.
Force is measured using a hand grip dynamometer.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Bone Impacts
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Estimate of bone impact activities using a waist-worn accelerometer monitored over 7 days.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Physical Activity (minutes/day)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Estimate of daily moderate-to-vigorous physical activity using a waist-worn accelerometer monitored over 7 days.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Food Frequency Questionnaire
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Estimate of daily intakes of calcium, protein and vitamin D. Estimates will be derived using the Food Frequency Questionnaire.
Participants will be asked to recall their consumption of various foods over the last 6 months and rate their intake on a scale from Never to consuming the food item 5-6 per week.
These ratings are then used to estimate the daily intake of calcum, protein and vitamin D.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Health
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
For children with type-I diabetes, investigators will record the onset of T1D (years), insulin regimen and various measures of glycemic control (e.g., HbA1c) using open-ended questionnaires and participants' medical records.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Osteocalcin
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Biochemical assessment of bone formation.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Procollagen type I N-propeptide (P1NP-N)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Biochemical assessment of bone formation.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
C-terminal telopepide (CTx)
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Biochemical assessment of bone resorption.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Sclerostin
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Biochemical assessment of bone resorption.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Insulin growth factor-1
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Biochemical assessment of hormones.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Alkaline phosphatase
Time Frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Biochemical assessment of hormones.
|
Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-301
- 488294 (Other Grant/Funding Number: Canadian Institute for Health Research)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Type-1 Diabetes
-
Poznan University of Medical SciencesUnknownDiabetes Mellitus Type 1 | Remission of Type 1 Diabetes | Chronic Complications of DiabetesPoland
-
Eledon PharmaceuticalsWithdrawnBrittle Type 1 Diabetes MellitusUnited States
-
National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)CompletedType 1 Diabetes Mellitus | T1DM | T1D | New-onset Type 1 Diabetes MellitusUnited States, Australia
-
Hoffmann-La RocheCompletedType 2 Diabetes, Type 1 DiabetesAustria, United Kingdom
-
Shanghai Changzheng HospitalRecruitingBrittle Type 1 Diabetes MellitusChina
-
Capillary Biomedical, Inc.TerminatedType 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Type I | Diabetes Mellitus, Insulin-Dependent, 1 | IDDMAustria
-
Capillary Biomedical, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Type 1 Diabetes Mellitus | Diabetes Mellitus, Insulin-Dependent, 1Australia
-
AstraZenecaCompletedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
Rabin Medical CenterDreaMed DiabetesTerminated