Jump-In: Building Better Bones
3 marzo 2021 aggiornato da: Scott Going, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Exercise and Bone Development in Young Girls
The Jump-In study will prospectively assess the effects of impact exercise on skeletal development in young girls, including bone mass, bone mineral density, and bone geometry.
We hypothesize that girls who regularly participate in impact loading exercise will accrue greater skeletal mass, increase bone density and undergo structural adaptations that in combination will improve bone strength compared to girls who do not participate in impact exercise.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Jump-In is a school-based, block-randomized, trial of the effects of impact-loading exercise on skeletal development in prepubescent and early pubescent girls.
Fourth (n=~200) and sixth (n=~200) grade girls in 14 Tucson (Arizona) schools with no contraindication to physical exercise will be enrolled.
Girls in intervention schools will participate in impact activities 3 times per week at school, progressively increasing the number (up to 40) of jumps and their height (from 6 inches to 18 inches per repetition) over the initial 2 months.
Thereafter, new activities will be introduced approximately every 2-3 months to maintain interest and motivation, and continually stress the skeleton in novel ways, over 2 years of intervention.
Physical and behavioral assessments will be done in both intervention and control groups at baseline, end of the initial school year, and yearly thereafter for 5 years.
Assessments include height and weight, selected skeletal lengths, fat, lean soft tissue, bone mineral content and areal density from dual energy x-ray absorptiometry (DXA), and bone geometry (e.g., cortical thickness, periosteal circumference and cortical and trabecular density) and muscle area from peripheral quantitative computed tomography (pQCT).
Also, maturation will be assessed via the Tanner Stage (self-assessment against standardized drawings of stages of physical development), diet from the Harvard Youth Food Frequency Questionnaire, and physical activity using pedometers and standardized questionnaires.
We hypothesize that girls in intervention schools will demonstrate enhanced skeletal development, including greater mineral mass and density, and enhanced bone geometry, leading to greater bone strength compared to girls in control schools.
We further hypothesize that younger (Tanner Stage 1) girls will experience greater adaptations than older girls (Tanner 2 and 3), and that positive adaptations will be maintained throughout the 3-year follow-up period.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
509
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Arizona
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Tucson, Arizona, Stati Uniti, 85721
- University of Arizona-Ina Gittings Bldg. #93
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 9 anni a 12 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Femmina
Descrizione
Inclusion Criteria:
female; entering 4th or 6th grade at enrollment; and willing and able to undergo all of the testing requirements; no physical conditions that limit participation in physical activity/exercise; able to read and write English.
Exclusion Criteria:
Girls with severe learning disabilities (identified by schools), who are unable to complete questionnaires or otherwise comply with assessment protocols will be excluded. Any subjects (or potential subjects) suffering from medical conditions and/or disabilities that would limit their participation in exercise will be excluded from the study, following the American Academy of Pediatrics (AAP) guidelines. Further, any volunteers who are taking medications that would limit exercise and/or alter bone mineral accrual will also be excluded from the study. Girls with a positive pregnancy screening test at the time of the lab visit before DXA scanning will be excluded.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Exercise Intervention
Implementation of intervention program designed to provide skeletal loading through high impact activities.
All activities performed by subjects in exercise intervention arm will be assessed by physical activity questionnaire and use of pedometer.
Have baseline anthropometric measurements, total body DXA scans and peripheral quantitative computed tomography (pQCT) scans of the tibia and femur.
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Impact activities, 3 times per week, increasing the number of jumps (up to 40) and increasing height (from 6 inches to 24 inches per repetition) over the initial 8-weeks (2 months).
New activities will be introduced approximately every 2-3 months in order to continually stress the skeleton over 2 years.
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|
Nessun intervento: Control
Participants in this arm will not take part in exercise intervention.
All activities performed by subjects in control arm will be assessed by physical activity questionnaire and use of pedometer.
Have baseline anthropometric measurements, total body DXA scans and peripheral quantitative computed tomography (pQCT) scans of the tibia and femur.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Baseline Total Volumetric Bone Density at the Femur 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of total volumetric bone density at the femur 4% site.
Measurement made by peripheral quantitative computed tomography (pQCT) at a distance of 4% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Volumetric Bone Density of Cortical Bone at the Femur 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Trabecular Bone Area at the Femur 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of trabecular bone area at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline
|
|
Baseline Cortical Bone Area at the Femur 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of cortical bone area at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline
|
|
Baseline Periosteal Circumference at the Femur 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of periosteal circumference at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline
|
|
Baseline Bone Strength Index at the Femur 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of bone strength index (BSI) at the femur 4% site.
Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones.
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: mm^4.
|
Baseline
|
|
Baseline Total Volumetric Bone Density at the Femur 20% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of total volumetric bone density at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of volumetric bone density of trabecular bone at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Volumetric Bone Density of Cortical Bone at the Femur 20% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of volumetric bone density of Cortical bone at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Periosteal Circumference at the Femur 20% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of periosteal circumference at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline
|
|
Baseline Cortical Thickness at the Femur 20% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of cortical thickness at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline
|
|
Baseline Stress-Strain Index at the Femur 20% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of stress-strain index at the femur 20% site.
Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones.
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: mm^3.
|
Baseline
|
|
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Total Volumetric Bone Density at the Tibia 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of total volumetric bone density at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Trabecular Bone Area at the Tibia 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of trabecular bone area at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline
|
|
Baseline Cortical Bone Area at the Tibia 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of cortical bone area at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline
|
|
Baseline Periosteal Circumference at the Tibia 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of periosteal circumference at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline
|
|
Baseline Bone Strength Index at the Tibia 4% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of bone strength index (BSI) at the tibia 4% site.
Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones.
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: mm^4.
|
Baseline
|
|
Baseline Total Volumetric Bone Density at the Tibia 50% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of total volumetric bone density at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Periosteal Circumference at the Tibia 50% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of periosteal circumference at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline
|
|
Baseline Cortical Thickness at the Tibia 50% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of cortical thickness at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline
|
|
Baseline Stress-Strain Index at the Tibia 50% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of stress-strain index at the tibia 50% site.
Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones.
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: mm^3.
|
Baseline
|
|
Baseline Total Volumetric Bone Density at the Tibia 66% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of total volumetric bone density at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of volumetric bone density of trabecular bone at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of volumetric bone density of cortical bone at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline
|
|
Baseline Periosteal Circumference at the Tibia 66% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of periosteal circumference at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline
|
|
Baseline Cortical Thickness at the Tibia 66% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of cortical thickness at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline
|
|
Baseline Stress-Strain Index at the Tibia 66% Site
Lasso di tempo: Baseline
|
Baseline (initial) measurement of strength-strain index at the tibia 66% site.
Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones.
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: mm^3.
|
Baseline
|
|
12-month Change in Total Volumetric Bone Density the Femur 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in total volumetric bone density at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in volumetric bone density of cortical bone at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Trabecular Bone Area at the Femur 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in trabecular bone area at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline to 12-months
|
|
12-month Change in Cortical Bone Area at the Femur 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in cortical bone area at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline to 12-months
|
|
12-month Change in Periosteal Circumference at the Femur 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in periosteal circumference at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 12-months
|
|
12-month Change in Bone Strength Index at the Femur 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in bone strength index (BSI) at the femur 4% site.
Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones.
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: mm^4.
|
Baseline to 12-months
|
|
12-month Change in Total Volumetric Bone Density at the Femur 20% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in total volumetric bone density at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in volumetric bone density of trabecular bone at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in volumetric bone density of cortical bone at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Thickness of Cortical Bone at the Femur 20% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in thickness of cortical bone at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units millimeters (mm).
|
Baseline to 12-months
|
|
12-month Change in Periosteal Circumference at the Femur 20% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in periosteal circumference at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 12-months
|
|
12-month Change in Stress-Strain Index at the Femur 20% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in strength-strain index at the femur 20% site.
Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones.
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: mm^3.
|
Baseline to 12-months
|
|
12-month Change in Total Volumetric Bone Density at the Tibia 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in total volumetric bone density at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Trabecular Bone Area at the Tibia 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in trabecular bone area at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline to 12-months
|
|
12-month Change in Cortical Bone Area at the Tibia 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in cortical bone area at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline to 12-months
|
|
12-month Change in Periosteal Circumference at the Tibia 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in periosteal circumference at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 12-months
|
|
12-month Change in Bone Strength Index at the Tibia 4% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in bone strength index (BSI) at the tibia 4% site.
Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones.
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: mm^4.
|
Baseline to 12-months
|
|
12-month Change in Total Volumetric Bone Density at the Tibia 50% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in total volumetric bone density at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Periosteal Circumference at the Tibia 50% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in periosteal circumference at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 12-months
|
|
12-month Change in Cortical Thickness at the Tibia 50% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in cortical thickness at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 12-months
|
|
12-month Change in Stress-Strain Index at the Tibia 50% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in strength-strain index at the tibia 50% site.
Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones.
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: mm^3.
|
Baseline to 12-months
|
|
12-month Change in Total Volumetric Bone Density at the Tibia 66% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in total volumetric bone density at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in volumetric bone density of trabecular bone at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in volumetric bone density of cortical bone at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 12-months
|
|
12-month Change in Periosteal Circumference at the Tibia 66% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in periosteal circumference at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 12-months
|
|
12-month Change in Cortical Thickness at the Tibia 66% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in cortical thickness at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 12-months
|
|
12-month Change in Stress-Strain Index at the Tibia 66% Site
Lasso di tempo: Baseline to 12-months
|
Baseline to 12-month change in strength-strain index at the tibia 66% site.
Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones.
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: mm^3.
|
Baseline to 12-months
|
|
24-month in Change in Total Volumetric Bone Density the Femur 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in total volumetric bone density at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units mg/ccm.
|
Baseline to 24-months
|
|
24-month in Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month in Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in volumetric bone density of cortical bone at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Trabecular Bone Area at the Femur 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in trabecular bone area at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline to 24-months
|
|
24-month Change in Cortical Bone Area at the Femur 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in cortical bone area at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline to 24-months
|
|
24-month Change in Periosteal Circumference at the Femur 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in periosteal circumference at the femur 4% site .
Measurement made by pQCT at a distance of 4% of total femur length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 24-months
|
|
24-month Change in Bone Strength Index at the Femur 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in bone strength index (BSI) at the femur 4% site.
Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones.
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: mm^4.
|
Baseline to 24-months
|
|
24-month Change in Total Volumetric Bone Density at the Femur 20% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in total volumetric bone density at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in volumetric bone density of trabecular bone at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in volumetric bone density of cortical bone at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Thickness of Cortical Bone at the Femur 20% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in thickness of cortical bone at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 24-months
|
|
24-month Change in Periosteal Circumference at the Femur 20% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in periosteal circumference at the femur 20% site .
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 24-months
|
|
24-month Change in Stress-Strain Index at the Femur 20% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in strength-strain index at the femur 20% site.
Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones.
Measurement made by pQCT at a distance of 20% of total femur length from the distal growth plate.
Measurement units: mm^3.
|
Baseline to 24-months
|
|
24-month Change in Total Volumetric Bone Density at the Tibia 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in total volumetric bone density at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Trabecular Bone Area at the Tibia 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in trabecular bone area at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline to 24-months
|
|
24-month Change in Cortical Bone Area at the Tibia 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in cortical bone area at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: square millimeters (mm^2).
|
Baseline to 24-months
|
|
24-month Change in Periosteal Circumference at the Tibia 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in periosteal circumference at the tibia 4% site .
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 24-months
|
|
24-month Change in Bone Strength Index at the Tibia 4% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in bone strength index (BSI) at the tibia 4% site.
Bone Strength Index (BSI) is a measurement of the resistance to compression forces at the epiphyses of long bones.
Measurement made by pQCT at a distance of 4% of total tibia length from the distal growth plate.
Measurement units: mm^4.
|
Baseline to 24-months
|
|
24-month Change in Total Volumetric Bone Density at the Tibia 50% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in total volumetric bone density at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Periosteal Circumference at the Tibia 50% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month measurement of periosteal circumference at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 24-months
|
|
24-month Change in Cortical Thickness at the Tibia 50% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in cortical thickness at the tibia 50% site .
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 24-months
|
|
24-month Change in Stress-Strain Index at the Tibia 50% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in strength-strain index at the tibia 50% site.
Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones.
Measurement made by pQCT at a distance of 50% of total tibia length from the distal growth plate.
Measurement units: mm^3.
|
Baseline to 24-months
|
|
24-month Change in Total Volumetric Bone Density at the Tibia 66% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in total volumetric bone density at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in volumetric bone density of trabecular bone at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in volumetric bone density of cortical bone at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: milligrams per cubic centimeter (mg/ccm).
|
Baseline to 24-months
|
|
24-month Change in Periosteal Circumference at the Tibia 66% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in periosteal circumference at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 24-months
|
|
24-month Change in Cortical Thickness at the Tibia 66% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in cortical thickness at the tibia 66% site .
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: millimeters (mm).
|
Baseline to 24-months
|
|
24-month Change in Stress-Strain Index at the Tibia 66% Site
Lasso di tempo: Baseline to 24-months
|
Baseline to 24-month change in strength-strain index at the tibia 66% site.
Stress-strain index (also called strength-strain index and stress-strength index in the literature) is a measure of the resistance to torsional and bending forces at diaphyseal sites of long bones.
Measurement made by pQCT at a distance of 66% of total tibia length from the distal growth plate.
Measurement units: mm^3.
|
Baseline to 24-months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Scott Going, Ph.D., University of Arizona-Dept. of Nutritional Sciences
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Farr JN, Van Loan MD, Lohman TG, Going SB. Lower physical activity is associated with skeletal muscle fat content in girls. Med Sci Sports Exerc. 2012 Jul;44(7):1375-81. doi: 10.1249/MSS.0b013e31824749b2.
- Farr JN, Tomas R, Chen Z, Lisse JR, Lohman TG, Going SB. Lower trabecular volumetric BMD at metaphyseal regions of weight-bearing bones is associated with prior fracture in young girls. J Bone Miner Res. 2011 Feb;26(2):380-7. doi: 10.1002/jbmr.218.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2007
Completamento primario (Effettivo)
1 aprile 2012
Completamento dello studio (Effettivo)
1 aprile 2013
Date di iscrizione allo studio
Primo inviato
5 agosto 2008
Primo inviato che soddisfa i criteri di controllo qualità
5 agosto 2008
Primo Inserito (Stima)
7 agosto 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 marzo 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 marzo 2021
Ultimo verificato
1 marzo 2021
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- HD050775
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .