NCT Number: NCT04135196
The purpose of this study is to understand how different types of mechanical forces can influence bone adaptation (and make bones stronger, potentially). Forces acting on bones cause mechanical strain. In small animals, strain magnitude and rate have been shown to stimulate bone adaptation. This study is designed to test the degree to which strain magnitude and rate govern bone adaptation in healthy adult women.
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Notify Me21 year–40 year
Female
Interventional
Not applicable
The study consists of three Aims:
Aim 1: compare the effect on bone structure of mechanical signals with low strain magnitude, high strain magnitude, and control groups over a 12-month prospective period.
Aim 2. Compare the effect on bone structure of mechanical signals with low strain rate, high strain rate, and control groups over a 12-month prospective period.
Aim 3: Examine the effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.
The intervention is a voluntary forearm compression task, consisting of leaning onto the palm of the hand to produce a target force.
The primary outcome measure is change in distal radius bone mineral content (BMC).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
Time frame: baseline and 12 months
12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT)
Time frame: baseline and 12 months
12-month change in ultra-distal cortical bone mineral content, measured with quantitative computed tomography (QCT)
Time frame: baseline and 12 months
12-month change in ultra-distal endocortical bone mineral content, measured with quantitative computed tomography (QCT)
Time frame: baseline and 12 months
12-month change in ultra-distal trabecular bone mineral content, measured with quantitative computed tomography (QCT)
Time frame: baseline and 12 months
12-month change in ultra-distal integral volumetric bone mineral density, measured with quantitative computed tomography (QCT)
Time frame: baseline and 12 months
12-month change in ultra-distal cortical volumetric bone mineral density, measured with quantitative computed tomography (QCT)
Time frame: baseline and 12 months
12-month change in ultra-distal endocortical bone mineral density, measured with quantitative computed tomography (QCT)
Time frame: baseline and 12 months
12-month change in ultra-distal trabecular bone mineral density, measured with quantitative computed tomography (QCT)
Time frame: baseline and 12 months
12-month change in ultra-distal integral bone volume, measured with quantitative computed tomography (QCT)
Time frame: baseline and 12 months
12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)
Time frame: baseline and 12 months
12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)
Time frame: baseline and 12 months
12-month change in ultra-distal trabecular bone volume, measured with quantitative computed tomography (QCT)
Time frame: measurements repeated at 0, 3, 6, 9, 12, 18, and 24 months from enrollment
Changes in cortical thickness at 3-month intervals, measured with high resolution peripheral quantitative computed tomography (HRpQCT)
Time frame: measurements repeated at 0, 3, 6, 9, and 12 months from enrollment
trabecular bone volume fraction expressed as the ratio of bone volume (BV) to total volume (TV) using: (BV/TV). This quantity is measured with high resolution peripheral quantitative computed tomography (HRpQCT). It is expressed as a ratio, ranging from 0 (none of the volume is occupied by bone) to 1 (all of the volume is occupied by bone).
Worcester Polytechnic Institute
Other
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