Canadian Bone Strength Development Study

NCT06287840 | Recruiting

• 2 other identifiers: 17-301488294
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

Type-1 Diabetes

Keywords

Type-1 Diabetes; Bone; Growth; Children; Physical Activity

Outcome Measures

Primary Outcomes (2)

• Trabecular Thickness (μm)

  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)

  Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).

  Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up

Secondary Outcomes (23)

• Total, Cortical and Trabecular Bone Area (mm^2)

  Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up

• Total, Cortical and Trabecular Bone Density (mg HA/cm^3)

  Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up

• Cortical Thickness (μm)

  Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up

• Cortical Porosity

  Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up

• Trabecular Bone Volume Fraction (%)

  Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up

Study Arms (2)

Children with Type-1 Diabetes

* Females: 10-11 years old * Males: 11-12 years old * Diagnosed with type-1 diabetes for at least 6 months

Control

* Females: 10-11 years old * Males: 11-12 years old

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

primary care clinic, community sample

You may qualify if:

• 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.

You may not qualify if:

• 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):
• 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.
• 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.

Sponsors & Collaborators

• University of Saskatchewan: lead
• University of Calgary: collaborator
• The Hospital for Sick Children: collaborator
• Children's Hospital of Eastern Ontario: collaborator

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5B2, Canada

RECRUITING

Biospecimen

Retention: NONE RETAINED

Serum from Children with Type-I Diabetes

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Saija Kontulainen, PhD

CONTACT

(306)966-1077; saija.kontulainen@usask.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Associate Dean Research and Graduate Studies, Graduate Chair

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 1, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

CA (1)