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Jump-In: Building Better Bones

3. mars 2021 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

509

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Tucson, Arizona, Forente stater, 85721
        • University of Arizona-Ina Gittings Bldg. #93

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

9 år til 12 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline Total Volumetric Bone Density at the Femur 4% Site
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2007

Primær fullføring (Faktiske)

1. april 2012

Studiet fullført (Faktiske)

1. april 2013

Datoer for studieregistrering

Først innsendt

5. august 2008

Først innsendt som oppfylte QC-kriteriene

5. august 2008

Først lagt ut (Anslag)

7. august 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • HD050775

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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