Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 1 of 1 for:    NCT 00729378
Previous Study | Return to List | Next Study

Jump-In: Building Better Bones

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00729378
Recruitment Status : Completed
First Posted : August 7, 2008
Results First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Scott Going, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Tracking Information
First Submitted Date  ICMJE August 5, 2008
First Posted Date  ICMJE August 7, 2008
Results First Submitted Date  ICMJE April 24, 2017
Results First Posted Date  ICMJE December 8, 2017
Last Update Posted Date December 8, 2017
Study Start Date  ICMJE April 2007
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
  • Baseline Total Volumetric Bone Density at the Femur 4% Site [ Time Frame: 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 Volumetric Bone Density of Trabecular Bone at the Femur 4% Site [ Time Frame: 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 Volumetric Bone Density of Cortical Bone at the Femur 4% Site [ Time Frame: 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 Trabecular Bone Area at the Femur 4% Site [ Time Frame: 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 Cortical Bone Area at the Femur 4% Site [ Time Frame: 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 Periosteal Circumference at the Femur 4% Site [ Time Frame: 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 Bone Strength Index at the Femur 4% Site [ Time Frame: 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 Total Volumetric Bone Density at the Femur 20% Site [ Time Frame: 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 Volumetric Bone Density of Trabecular Bone at the Femur 20% Site [ Time Frame: 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 Volumetric Bone Density of Cortical Bone at the Femur 20% Site [ Time Frame: 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 Periosteal Circumference at the Femur 20% Site [ Time Frame: 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 Cortical Thickness at the Femur 20% Site [ Time Frame: 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 Stress-Strain Index at the Femur 20% Site [ Time Frame: 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 Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site [ Time Frame: 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 Total Volumetric Bone Density at the Tibia 4% Site [ Time Frame: 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 Volumetric Bone Density of Cortical Bone at the Tibia 4% Site [ Time Frame: 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 Trabecular Bone Area at the Tibia 4% Site [ Time Frame: 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 Cortical Bone Area at the Tibia 4% Site [ Time Frame: 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 Periosteal Circumference at the Tibia 4% Site [ Time Frame: 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 Bone Strength Index at the Tibia 4% Site [ Time Frame: 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 Total Volumetric Bone Density at the Tibia 50% Site [ Time Frame: 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 Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site [ Time Frame: 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 Volumetric Bone Density of Cortical Bone at the Tibia 50% Site [ Time Frame: 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 Periosteal Circumference at the Tibia 50% Site [ Time Frame: 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 Cortical Thickness at the Tibia 50% Site [ Time Frame: 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 Stress-Strain Index at the Tibia 50% Site [ Time Frame: 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 Total Volumetric Bone Density at the Tibia 66% Site [ Time Frame: 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 Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site [ Time Frame: 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 Volumetric Bone Density of Cortical Bone at the Tibia 66% Site [ Time Frame: 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 Periosteal Circumference at the Tibia 66% Site [ Time Frame: 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 Cortical Thickness at the Tibia 66% Site [ Time Frame: 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 Stress-Strain Index at the Tibia 66% Site [ Time Frame: 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.
  • 12-month Change in Total Volumetric Bone Density the Femur 4% Site [ Time Frame: 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).
  • 12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site [ Time Frame: 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).
  • 12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site [ Time Frame: 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).
  • 12-month Change in Trabecular Bone Area at the Femur 4% Site [ Time Frame: 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).
  • 12-month Change in Cortical Bone Area at the Femur 4% Site [ Time Frame: 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).
  • 12-month Change in Periosteal Circumference at the Femur 4% Site [ Time Frame: 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).
  • 12-month Change in Bone Strength Index at the Femur 4% Site [ Time Frame: 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.
  • 12-month Change in Total Volumetric Bone Density at the Femur 20% Site [ Time Frame: 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).
  • 12-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site [ Time Frame: 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).
  • 12-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site [ Time Frame: 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).
  • 12-month Change in Thickness of Cortical Bone at the Femur 20% Site [ Time Frame: 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).
  • 12-month Change in Periosteal Circumference at the Femur 20% Site [ Time Frame: 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).
  • 12-month Change in Stress-Strain Index at the Femur 20% Site [ Time Frame: 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.
  • 12-month Change in Total Volumetric Bone Density at the Tibia 4% Site [ Time Frame: 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).
  • 12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site [ Time Frame: 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).
  • 12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site [ Time Frame: 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).
  • 12-month Change in Trabecular Bone Area at the Tibia 4% Site [ Time Frame: 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).
  • 12-month Change in Cortical Bone Area at the Tibia 4% Site [ Time Frame: 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).
  • 12-month Change in Periosteal Circumference at the Tibia 4% Site [ Time Frame: 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).
  • 12-month Change in Bone Strength Index at the Tibia 4% Site [ Time Frame: 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.
  • 12-month Change in Total Volumetric Bone Density at the Tibia 50% Site [ Time Frame: 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).
  • 12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site [ Time Frame: 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).
  • 12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site [ Time Frame: 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).
  • 12-month Change in Periosteal Circumference at the Tibia 50% Site [ Time Frame: 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).
  • 12-month Change in Cortical Thickness at the Tibia 50% Site [ Time Frame: 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).
  • 12-month Change in Stress-Strain Index at the Tibia 50% Site [ Time Frame: 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.
  • 12-month Change in Total Volumetric Bone Density at the Tibia 66% Site [ Time Frame: 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).
  • 12-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site [ Time Frame: 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).
  • 12-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site [ Time Frame: 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).
  • 12-month Change in Periosteal Circumference at the Tibia 66% Site [ Time Frame: 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).
  • 12-month Change in Cortical Thickness at the Tibia 66% Site [ Time Frame: 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).
  • 12-month Change in Stress-Strain Index at the Tibia 66% Site [ Time Frame: 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.
  • 24-month in Change in Total Volumetric Bone Density the Femur 4% Site [ Time Frame: 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.
  • 24-month in Change in Volumetric Bone Density of Trabecular Bone at the Femur 4% Site [ Time Frame: 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).
  • 24-month in Change in Volumetric Bone Density of Cortical Bone at the Femur 4% Site [ Time Frame: 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).
  • 24-month Change in Trabecular Bone Area at the Femur 4% Site [ Time Frame: 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).
  • 24-month Change in Cortical Bone Area at the Femur 4% Site [ Time Frame: 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).
  • 24-month Change in Periosteal Circumference at the Femur 4% Site [ Time Frame: 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).
  • 24-month Change in Bone Strength Index at the Femur 4% Site [ Time Frame: 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.
  • 24-month Change in Total Volumetric Bone Density at the Femur 20% Site [ Time Frame: 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).
  • 24-month Change in Volumetric Bone Density of Trabecular Bone at the Femur 20% Site [ Time Frame: 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).
  • 24-month Change in Volumetric Bone Density of Cortical Bone at the Femur 20% Site [ Time Frame: 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).
  • 24-month Change in Thickness of Cortical Bone at the Femur 20% Site [ Time Frame: 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).
  • 24-month Change in Periosteal Circumference at the Femur 20% Site [ Time Frame: 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).
  • 24-month Change in Stress-Strain Index at the Femur 20% Site [ Time Frame: 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.
  • 24-month Change in Total Volumetric Bone Density at the Tibia 4% Site [ Time Frame: 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).
  • 24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 4% Site [ Time Frame: 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).
  • 24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 4% Site [ Time Frame: 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).
  • 24-month Change in Trabecular Bone Area at the Tibia 4% Site [ Time Frame: 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).
  • 24-month Change in Cortical Bone Area at the Tibia 4% Site [ Time Frame: 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).
  • 24-month Change in Periosteal Circumference at the Tibia 4% Site [ Time Frame: 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).
  • 24-month Change in Bone Strength Index at the Tibia 4% Site [ Time Frame: 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.
  • 24-month Change in Total Volumetric Bone Density at the Tibia 50% Site [ Time Frame: 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).
  • 24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 50% Site [ Time Frame: 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).
  • 24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 50% Site [ Time Frame: 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).
  • 24-month Change in Periosteal Circumference at the Tibia 50% Site [ Time Frame: 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).
  • 24-month Change in Cortical Thickness at the Tibia 50% Site [ Time Frame: 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).
  • 24-month Change in Stress-Strain Index at the Tibia 50% Site [ Time Frame: 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.
  • 24-month Change in Total Volumetric Bone Density at the Tibia 66% Site [ Time Frame: 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).
  • 24-month Change in Volumetric Bone Density of Trabecular Bone at the Tibia 66% Site [ Time Frame: 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).
  • 24-month Change in Volumetric Bone Density of Cortical Bone at the Tibia 66% Site [ Time Frame: 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).
  • 24-month Change in Periosteal Circumference at the Tibia 66% Site [ Time Frame: 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).
  • 24-month Change in Cortical Thickness at the Tibia 66% Site [ Time Frame: 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).
  • 24-month Change in Stress-Strain Index at the Tibia 66% Site [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2008)
Bone density, geometry and strength from peripheral quantitative computed tomography (pQCT). [ Time Frame: Baseline, 6 months, one year; yearly thereafter for 4 years ]
Change History Complete list of historical versions of study NCT00729378 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2008)
Physical activity, soft tissue composition [ Time Frame: Baseline, 6 months, one year, yearly thereafter for 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Jump-In: Building Better Bones
Official Title  ICMJE Exercise and Bone Development in Young Girls
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Adolescent Development
Intervention  ICMJE Other: 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Other: Skeletal loading
  • No Intervention: 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2017)
509
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2008)
400
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 9 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00729378
Other Study ID Numbers  ICMJE HD050775
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Scott Going, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Sponsor  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott Going, Ph.D. University of Arizona-Dept. of Nutritional Sciences
PRS Account Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP