Determinants for Peak Bone Mass, Skeletal Architecture, Fractures, Adipositas and Cardiovascular Risk Factors During Growth and Adulthood
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Region Skane
- Enrollment
- 500
- Primary Endpoint
- BMD total body, femoral neck and lumbar spine (L2-L4) measured by Dual Energy X Ray Absorbtiometry
Study Overview
Brief Summary
Objective:
Prospective study regulation in bone mass, size, architecture, cortical, trabecular bone, soft tissues and risk factors for cardiovascular disease at growth. Determine regulation by environmental factors. Evaluate how training affects the skeleton, soft tissues and cardiovascular risk factors during growth Material/Methods: (i) 500 children in one RCT´s with or without intervention with physical activity (daily scholl physical education) from school start to college. Annual evaluations
Importance:
The investigators provide increased understanding of the pathophysiology of osteoporosis by determine the mineralization, size- and architecture development during growth and adulthood. Evaluate if intervention program with exercise increase bone strength, muscle mass and reduce fatness and risk factor for cardiovascular disease.
Background:
Skeletal growth and the age related bone loss determine who will get osteoporosis (and fractures), but not only bone mass, also skeletal architecture and bone quality influence bone strength. Regulation of the traits differs where hormones, genetics and environmental factors continuously influence the development with different effect during different ages. It is thus imperative to determine the regulators of the traits and evaluate if these can be modified during growth.
Aim:
Study regulation of bone mass, size, architecture, cortical, trabecular, axial and appendicular bone and soft tissue during growth and aging; evaluate risk factors for cardiovascular disease; determine importance of environmental factors and hereditary factors.
Study Design/Method
Bunkeflo Cohort:
Prospective, controlled exercise intervention study annually following skeletal development in 500children from age 7.
Importance:
By evaluating skeletal mass/architecture separate we will increase the understanding of the pathophysiology of osteoporosis. The intervention study provide Evidence Based Information as regard the importance of physical activity during growth. The presented Strength Index, where we combine bone mass and skeletal architecture, may predict fractures better than only bone mass.
Detailed Description
Determinants for Peak Bone Mass, Skeletal Architecture, Fractures, Adipositas and Cardiovascular Risk Factors During Growth and Adulthood
Aim of the project:
In the THE BUNKEFLO COHORT we determine if the growing skeleton, fat mass and risk factors for cardiovascular disease irreversible can be influenced by environmental influences as exercise and disease.
Background:
Bone mass, cortical thickness and bone geometry independently contribute to bone strength, all regulated differently. Thus, the regulation must therefore be trait specific studied as to understand the pathophysiology of osteoporosis as osteoporosis may partly be the result of deficits occurring during growth. We must also better discriminate the different traits building the skeleton. Areal bone mineral density (aBMD), measured by dual X-ray absorptiometry (DXA) the clinically used estimation of bone mass, is an estimate only adjusted for the measured area, not the third dimension (the depth), but aBMD is often uncritically used as a measurement for the "true density". As to predict future fragility fracture, aBMD is acceptable, but for the understanding of reduced bone strength, we must separate the estimation into bone mass, the amount of bone within the skeletal envelope, bone size and skeletal structure (architecture) as these traits are independent associated with fractures.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All included within the classes, population based cohort
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
BMD total body, femoral neck and lumbar spine (L2-L4) measured by Dual Energy X Ray Absorbtiometry
Time Frame: 15 years
Secondary Outcomes
- Bone mineral content (BMC) measured by DEXA and PQCT(15 years)
- Trabecular BMD measured by PQCT(15 years)
- Speed of sound (SOS) measured by quantitative ultrasound(15 years)
- Isodynamic muscle strength in thigh (knee extension and knee flexion, functional results of physiotherapy tests and CYBEX apparatus(15 years)
- Bone mineral density (aBMD) measured by DEXA, ultrasound and PQCT(15 years)
- Periosteal diameter measured by DEXA andPQCT(15 years)
- Cross sectional area (CSA) measured by PQCT(15 years)
- Fracture incidence determined through the radiographica archives in Malmö(15 years)
- Broadband attenuation (BUA) measured by quantitative ultrasound(15 years)
- DXA derived fat content and lean body mass from total body scan(15 years)
- Volumetric bone density (vBMD) measured by DEXA and PQCT(15 years)
- Medullary diameter measured by PQCT(15 years)
- Hip strength analysis (HSA) measured by DEXA(15 years)
- Cortical BMD measured by PQCT(15 years)
- Cardiovascular risk factors(15 years)