A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bone Loss
- Sponsor
- Worcester Polytechnic Institute
- Enrollment
- 102
- Primary Endpoint
- Change in UD iBMC
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Fracture to wrist \<5 years ago
- •Wrist Arthritis
- •Injury to the non-dominant elbow or shoulder \<5 years ago
- •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
Outcomes
Primary Outcomes
Change in UD iBMC
Time Frame: baseline and 12 months
12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT)
Secondary Outcomes
- Change in UD iBV(baseline and 12 months)
- Change in UD tBV(baseline and 12 months)
- Change in UD cBV(baseline and 12 months)
- Change in UD ecBMC(baseline and 12 months)
- Change in UD cBMC(baseline and 12 months)
- Change in UD tBMC(baseline and 12 months)
- Change in UD iBMD(baseline and 12 months)
- Change in UD cBMD(baseline and 12 months)
- Change in UD ecBMD(baseline and 12 months)
- Change in UD tBMD(baseline and 12 months)
- Change in UD ecBV(baseline and 12 months)
- Change in Trabecular BV/TV(measurements repeated at 0, 3, 6, 9, and 12 months from enrollment)
- Change in Cortical Thickness(measurements repeated at 0, 3, 6, 9, 12, 18, and 24 months from enrollment)