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| Sponsored by: |
Malmö University Hospital |
|---|---|
| Information provided by: | Malmö University Hospital |
| ClinicalTrials.gov Identifier: | NCT00633828 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Fractures |
Behavioral: Daily School physical education |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Determinants for Peak Bone Mass, Skeletal Architecture, Fractures, Adipositas and Cardiovascular Risk Factors During Growth and Adulthood |
| Enrollment: | 500 |
| Study Start Date: | August 1999 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Daily School physical education
|
Behavioral: Daily School physical education
Daily School physical education 40 minutes per day
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 6 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Region Scania ( Region Scania ) |
| Study ID Numbers: | NKOISR10002 |
| Study First Received: | March 4, 2008 |
| Last Updated: | March 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00633828 History of Changes |
| Health Authority: | Sweden: Regional Ethical Review Board |
|
Bone Density Bone mass Bone mineral density Bone structure |
Cardiovascular risk factors Fat Mass Adiposity |
|
Obesity Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |
|
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin |
