- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00729378
Jump-In: Building Better Bones
Exercise and Bone Development in Young Girls
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85721
- University of Arizona-Ina Gittings Bldg. #93
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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.
|
Baseline
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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.
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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.
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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.
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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.
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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).
|
Baseline to 12-months
|
|
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.
|
Baseline to 12-months
|
|
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.
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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.
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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.
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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.
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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.
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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).
|
Baseline to 24-months
|
|
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.
|
Baseline to 24-months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Scott Going, Ph.D., University of Arizona-Dept. of Nutritional Sciences
Publications and helpful links
General Publications
- Farr JN, Van Loan MD, Lohman TG, Going SB. Lower physical activity is associated with skeletal muscle fat content in girls. Med Sci Sports Exerc. 2012 Jul;44(7):1375-81. doi: 10.1249/MSS.0b013e31824749b2.
- Farr JN, Tomas R, Chen Z, Lisse JR, Lohman TG, Going SB. Lower trabecular volumetric BMD at metaphyseal regions of weight-bearing bones is associated with prior fracture in young girls. J Bone Miner Res. 2011 Feb;26(2):380-7. doi: 10.1002/jbmr.218.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HD050775
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adolescent Development
-
University of HaifaThe Academic college Levinsky-Wingate at the Wingate Institute, Netanya,...CompletedDevelopment, AdolescentIsrael
-
Erzurum Technical UniversityCompletedAdolescent DevelopmentTurkey
-
University of California, San DiegoSave the Children Netherlands; GRADE AfricaCompleted
-
University of HaifaRecruitingDevelopment, AdolescentIsrael
-
University of EdinburghCompleted
-
Brigham and Women's HospitalKripalu Center for Yoga and HealthCompleted
-
Western University, CanadaPublic Health Agency of Canada (PHAC)Completed
-
The University of Hong KongCompleted
-
National Institute of Environmental Health Sciences...RecruitingAdolescent Health | Pediatrics | Adolescent Development | Reproductive Physiological ProcessesUnited States
-
Centre BesaiUniversity of BarcelonaRecruitingHealthy | Adolescent DevelopmentSpain
Clinical Trials on Skeletal loading
-
US Department of Veterans AffairsBrown University; LifespanCompletedTraumatic Amputation of ArmUnited States
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin; DENTOSCompleted
-
Assiut UniversityNot yet recruitingSkeletal Muscle Ultrasonography
-
University of Alabama at BirminghamMayo Clinic; National Institute of Diabetes and Digestive and Kidney Diseases...CompletedDiabetes Mellitus, Type 2 | Diabetes MellitusUnited States
-
Centre Hospitalier Universitaire de Saint EtienneInstitut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement and other collaboratorsCompleted
-
University of Sao PauloUnknownPrimary Total Hip ArthroplastyBrazil
-
Universidad de GranadaCompleted
-
Folktandvården Skåne ABCompleted
-
Rutgers, The State University of New JerseyUnknownSlipped Capital Femoral EpiphysisUnited States
-
Postgraduate Institute of Dental Sciences RohtakCompleted