Influence of External Factors on Skeletal Growth in Youth
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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: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Determinants for Peak Bone Mass, Skeletal Architecture, Fractures, Adipositas and Cardiovascular Risk Factors During Growth and Adulthood |
- BMD total body, femoral neck and lumbar spine (L2-L4) measured by Dual Energy X Ray Absorbtiometry [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Bone mineral content (BMC) measured by DEXA and PQCT [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Bone mineral density (aBMD) measured by DEXA, ultrasound and PQCT [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Volumetric bone density (vBMD) measured by DEXA and PQCT [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Trabecular BMD measured by PQCT [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Cortical BMD measured by PQCT [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Periosteal diameter measured by DEXA andPQCT [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Medullary diameter measured by PQCT [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Cross sectional area (CSA) measured by PQCT [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Hip strength analysis (HSA) measured by DEXA [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Speed of sound (SOS) measured by quantitative ultrasound [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Broadband attenuation (BUA) measured by quantitative ultrasound [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Isodynamic muscle strength in thigh (knee extension and knee flexion, functional results of physiotherapy tests and CYBEX apparatus [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Fracture incidence determined through the radiographica archives in Malmö [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- DXA derived fat content and lean body mass from total body scan [ Time Frame: 15 years ] [ Designated as safety issue: No ]
- Cardiovascular risk factors [ Time Frame: 15 years ] [ Designated as safety issue: No ]
Risk factors measured as
- patients movement over 4 days measured by Accelerometer
- blood pressure
- heart volume by ultrasound
- lung function monitored by spirometer
- max VO2 from bicycle test
| Enrollment: | 500 |
| Study Start Date: | August 1999 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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:
- All included within the classes, population based cohort
Exclusion Criteria:
- None
Contacts and Locations| Principal Investigator: | Magnus Karlsson, M.D., Ph.D., Professor | Clinical and Molecular Osteoporosis Research Unit, Department of Clinical Sciences and Orthopaedic Surgery Lund University, Skåne Universíty Hospital |
More Information
No publications provided by Region Skane
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Region Skane |
| ClinicalTrials.gov Identifier: | NCT00633828 History of Changes |
| Other Study ID Numbers: | NKOISR10002 |
| Study First Received: | March 4, 2008 |
| Last Updated: | September 6, 2011 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Keywords provided by Region Skane:
|
Bone Density Bone mass Bone mineral density Bone structure |
Cardiovascular risk factors Fat Mass Adiposity |
Additional relevant MeSH terms:
|
Fractures, Bone Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013