Influence of External Factors on Skeletal Growth in Youth

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT00633828
First received: March 4, 2008
Last updated: August 9, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • All included within the classes, population based cohort

Exclusion Criteria:

  • None
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00633828

Sponsors and Collaborators
Region Skane
Investigators
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: August 9, 2013
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 September 14, 2014