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Jump-In: Building Better Bones

3 mars 2021 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

509

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Arizona
      • Tucson, Arizona, Förenta staterna, 85721
        • University of Arizona-Ina Gittings Bldg. #93

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

9 år till 12 år (Barn)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Skeletal loading
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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Baseline Total Volumetric Bone Density at the Femur 4% Site
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Utredare

  • Huvudutredare: Scott Going, Ph.D., University of Arizona-Dept. of Nutritional Sciences

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2007

Primärt slutförande (Faktisk)

1 april 2012

Avslutad studie (Faktisk)

1 april 2013

Studieregistreringsdatum

Först inskickad

5 augusti 2008

Först inskickad som uppfyllde QC-kriterierna

5 augusti 2008

Första postat (Uppskatta)

7 augusti 2008

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 mars 2021

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 mars 2021

Senast verifierad

1 mars 2021

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • HD050775

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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