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Influence of External Factors on Skeletal Growth in Youth

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ClinicalTrials.gov Identifier: NCT00633828
Recruitment Status : Active, not recruiting
First Posted : March 12, 2008
Last Update Posted : September 29, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


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


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.


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.


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.


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 or disease Intervention/treatment
Fractures Behavioral: Increased physical education in primary school (daily)

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Determinants for Peak Bone Mass, Skeletal Architecture, Fractures, Adipositas and Cardiovascular Risk Factors During Growth and Adulthood
Study Start Date : August 1999
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A Intervention group
Increased physical education in primary school (daily)
Behavioral: Increased physical education in primary school (daily)
Increased physical education in primary school, 40 minutes per day
No Intervention: B Control group
Normal physical education in primary school (typically once per week)

Outcome Measures

Primary Outcome Measures :
  1. BMD total body, femoral neck and lumbar spine (L2-L4) measured by Dual Energy X Ray Absorbtiometry [ Time Frame: 15 years ]

Secondary Outcome Measures :
  1. Bone mineral content (BMC) measured by DEXA and PQCT [ Time Frame: 15 years ]
  2. Bone mineral density (aBMD) measured by DEXA, ultrasound and PQCT [ Time Frame: 15 years ]
  3. Volumetric bone density (vBMD) measured by DEXA and PQCT [ Time Frame: 15 years ]
  4. Trabecular BMD measured by PQCT [ Time Frame: 15 years ]
  5. Cortical BMD measured by PQCT [ Time Frame: 15 years ]
  6. Periosteal diameter measured by DEXA andPQCT [ Time Frame: 15 years ]
  7. Medullary diameter measured by PQCT [ Time Frame: 15 years ]
  8. Cross sectional area (CSA) measured by PQCT [ Time Frame: 15 years ]
  9. Hip strength analysis (HSA) measured by DEXA [ Time Frame: 15 years ]
  10. Speed of sound (SOS) measured by quantitative ultrasound [ Time Frame: 15 years ]
  11. Broadband attenuation (BUA) measured by quantitative ultrasound [ Time Frame: 15 years ]
  12. Isodynamic muscle strength in thigh (knee extension and knee flexion, functional results of physiotherapy tests and CYBEX apparatus [ Time Frame: 15 years ]
  13. Fracture incidence determined through the radiographica archives in Malmö [ Time Frame: 15 years ]
  14. DXA derived fat content and lean body mass from total body scan [ Time Frame: 15 years ]
  15. Cardiovascular risk factors [ Time Frame: 15 years ]

    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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All included within the classes, population based cohort

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633828

Sponsors and Collaborators
Region Skane
Principal Investigator: Magnus Karlsson, M.D., Ph.D. Clinical and Molecular Osteoporosis Research Unit, Department of Clinical Sciences and Orthopaedic Surgery Lund University, Skåne Universíty Hospital