Influence of External Factors on Skeletal Growth in Youth

NCT00633828 | Active Not Recruiting

• 1 other identifier: NKOISR10002
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Bone Density; Bone mass; Bone mineral density; Bone structure; Cardiovascular risk factors; Fat Mass; Adiposity

Outcome Measures

Primary Outcomes (1)

• BMD total body, femoral neck and lumbar spine (L2-L4) measured by Dual Energy X Ray Absorbtiometry

  15 years

Secondary Outcomes (15)

• Bone mineral content (BMC) measured by DEXA and PQCT

  15 years

• Bone mineral density (aBMD) measured by DEXA, ultrasound and PQCT

  15 years

• Volumetric bone density (vBMD) measured by DEXA and PQCT

  15 years

• Trabecular BMD measured by PQCT

  15 years

• Cortical BMD measured by PQCT

  15 years

Study Arms (2)

A Intervention group

EXPERIMENTAL

Increased physical education in primary school (daily)

Behavioral: Increased physical education in primary school (daily)

B Control group

NO INTERVENTION

Normal physical education in primary school (typically once per week)

Interventions

Increased physical education in primary school (daily) BEHAVIORAL

Increased physical education in primary school, 40 minutes per day

A Intervention group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All included within the classes, population based cohort

You may not qualify if:

• None

Sponsors & Collaborators

• Region Skane: lead

Related Publications (6)

• Rosengren BE, Lindgren E, Jehpsson L, Dencker M, Karlsson MK. Musculoskeletal Benefits from a Physical Activity Program in Primary School are Retained 4 Years after the Program is Terminated. Calcif Tissue Int. 2021 Oct;109(4):405-414. doi: 10.1007/s00223-021-00853-0. Epub 2021 Apr 29.

  PMID: 33914096 DERIVED

• Lahti A, Rosengren BE, Dencker M, Nilsson JA, Karlsson MK. Socioecological and biological associations of lower levels of physical activity in 8-year-old children: a 2-year prospective study. BMJ Open Sport Exerc Med. 2019 Nov 21;5(1):e000597. doi: 10.1136/bmjsem-2019-000597. eCollection 2019.

  PMID: 31803494 DERIVED

• Stenevi Lundgren S, Rosengren BE, Dencker M, Nilsson JA, Karlsson C, Karlsson MK. Low physical activity is related to clustering of risk factors for fracture-a 2-year prospective study in children. Osteoporos Int. 2017 Dec;28(12):3373-3378. doi: 10.1007/s00198-017-4203-0. Epub 2017 Sep 15.

  PMID: 28913570 DERIVED

• Coster ME, Fritz J, Nilsson JA, Karlsson C, Rosengren BE, Dencker M, Karlsson MK. How does a physical activity programme in elementary school affect fracture risk? A prospective controlled intervention study in Malmo, Sweden. BMJ Open. 2017 Feb 23;7(2):e012513. doi: 10.1136/bmjopen-2016-012513.

  PMID: 28235964 DERIVED

• Detter F, Nilsson JA, Karlsson C, Dencker M, Rosengren BE, Karlsson MK. A 3-year school-based exercise intervention improves muscle strength - a prospective controlled population-based study in 223 children. BMC Musculoskelet Disord. 2014 Oct 27;15:353. doi: 10.1186/1471-2474-15-353.

  PMID: 25345446 DERIVED

• Lofgren B, Dencker M, Nilsson JA, Karlsson MK. A 4-year exercise program in children increases bone mass without increasing fracture risk. Pediatrics. 2012 Jun;129(6):e1468-76. doi: 10.1542/peds.2011-2274. Epub 2012 May 28.

  PMID: 22641757 DERIVED

MeSH Terms

Conditions

Fractures, Bone; Obesity

Interventions

Schools

Condition Hierarchy (Ancestors)

Wounds and Injuries; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

• Magnus Karlsson, M.D., Ph.D.

  Clinical and Molecular Osteoporosis Research Unit, Department of Clinical Sciences and Orthopaedic Surgery Lund University, Skåne Universíty Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: August 1, 1999
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2050
• Last Updated: June 27, 2025

Record last verified: 2025-06