Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06287840

Canadian Bone Strength Development 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:

1. 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. 2. 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. 3. 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Type-1 Diabetes Behavior Motor Activity

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5B2, Canada

Location status: Recruiting

Location contact

Saija Kontulainen, PhD

CONTACT

[email protected]

(306)966-1077

About this study

The Canadian Bone Strength Development Study is a multi-site project examining differences in bone development between children with and without type-1 diabetes. Research for this study will be conducted at the University of Saskatchewan, University of Calgary, The Hospital for Sick Children (SickKids) and The Children's Hospital of Eastern Ontario (CHEO). 204 children (50% female) will be included. Participants will make 4 annual visits to the laboratory. During each laboratory visit, anthropometric measurements (e.g., height and weight), bone strength and microarchitecture, muscle strength, nutrition and physical activity will be assessed. Investigators will compare between group differences in bone growth trajectories using multilevel models.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Osteocalcin

    Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up

    Biochemical assessment of bone formation.

  19. 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.

  20. C-terminal telopepide (CTx)

    Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up

    Biochemical assessment of bone resorption.

  21. Sclerostin

    Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up

    Biochemical assessment of bone resorption.

  22. Insulin growth factor-1

    Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up

    Biochemical assessment of hormones.

  23. Alkaline phosphatase

    Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up

    Biochemical assessment of hormones.

Study contacts

Contact information is provided by the study sponsor or research team.

Saija Kontulainen, PhD

CONTACT

[email protected]

(306)966-1077

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Children's Hospital of Eastern Ontario
  • The Hospital for Sick Children
  • University of Calgary

Registry information

Official study title

Canadian Bone Strength Development in Children With Type 1 Diabetes Study

Acronym: CanBSDS

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 1, 2024
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.