Influence of External Factors on Skeletal Growth in Youth

NCT00633828 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-06-27

No results posted yet for this study

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.

Conditions

  • Fractures

Interventions

BEHAVIORAL

Increased physical education in primary school (daily)

Increased physical education in primary school, 40 minutes per day

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Magnus Karlsson, M.D., Ph.D. · Clinical and Molecular Osteoporosis Research Unit, Department of Clinical Sciences and Orthopaedic Surgery Lund University, Skåne Universíty Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-08-31
Primary Completion
2030-12-31
Completion
2050-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00633828 on ClinicalTrials.gov