A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model
- Conditions
- Bone Loss
- Interventions
- Other: voluntary forearm loading task
- Registration Number
- NCT04135196
- Lead Sponsor
- Worcester Polytechnic Institute
- Brief Summary
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.
- Detailed Description
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effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 102
- Female
- Age 21-40
- Body Mass Index [18-29]
- 9-14 menstrual cycles/year
- Dual energy X-ray Absorptiometry total radius bone mineral density (BMD) T-score [-2.5-+1]
- Free of endocrinopathies
- No known thyroid, vitamin D, or calcium abnormalities
- Fracture to wrist <5 years ago
- Wrist Arthritis
- Injury to the non-dominant elbow or shoulder <5 years ago
- Diabetes
- Severe disabling conditions
- Cancer <5 years ago
- Metabolic bone disease
- Androgen, estrogen, progesterone, calcitonin, Selective Estrogen Receptor Modulators, Parathyroid hormone, gonadotropin-releasing hormone or analogs used <6 months ago
- Corticosteroids <3 months ago
- Bisphosphonates or fluoride <3 years ago
- Cardiovascular/pulmonary disease
- Uncontrolled hypertension
- Regular Tobacco use
- Marijuana use >1 time/week
- Alcohol >4 drinks/day
- Pregnancy or lactation <2 years ago
- Plan to become pregnant or donate eggs within 1 year
- Depot medroxyprogesterone acetate contraceptive <6 months ago
- Current participation in upper extremity loading sports (gymnastics, tennis, softball, hockey) >2 times/month
- Low calcium intake (avoiding dairy products without taking calcium supplement)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Magnitude voluntary forearm loading task voluntary forearm compression by leaning onto the palm of the hand with high target strain Low Rate voluntary forearm loading task voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly") Low Magnitude voluntary forearm loading task voluntary forearm compression by leaning onto the palm of the hand with low target strain High Rate voluntary forearm loading task voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
- Primary Outcome Measures
Name Time Method Change in UD iBMC baseline and 12 months 12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT)
- Secondary Outcome Measures
Name Time Method Change in UD iBV baseline and 12 months 12-month change in ultra-distal integral bone volume, measured with quantitative computed tomography (QCT)
Change in UD tBV baseline and 12 months 12-month change in ultra-distal trabecular bone volume, measured with quantitative computed tomography (QCT)
Change in UD cBV baseline and 12 months 12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)
Change in UD cBMD baseline and 12 months 12-month change in ultra-distal cortical volumetric bone mineral density, measured with quantitative computed tomography (QCT)
Change in UD ecBMC baseline and 12 months 12-month change in ultra-distal endocortical bone mineral content, measured with quantitative computed tomography (QCT)
Change in UD cBMC baseline and 12 months 12-month change in ultra-distal cortical bone mineral content, measured with quantitative computed tomography (QCT)
Change in UD tBMC baseline and 12 months 12-month change in ultra-distal trabecular bone mineral content, measured with quantitative computed tomography (QCT)
Change in UD iBMD baseline and 12 months 12-month change in ultra-distal integral volumetric bone mineral density, measured with quantitative computed tomography (QCT)
Change in UD ecBMD baseline and 12 months 12-month change in ultra-distal endocortical bone mineral density, measured with quantitative computed tomography (QCT)
Change in UD tBMD baseline and 12 months 12-month change in ultra-distal trabecular bone mineral density, measured with quantitative computed tomography (QCT)
Change in UD ecBV baseline and 12 months 12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)
Change in Trabecular BV/TV 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).
Change in Cortical Thickness 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)