A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model

Worcester Polytechnic Institute (WPI)

Status: Completed

Conditions: Bone Loss

Treatments: Other: voluntary forearm loading task

Study type: Interventional

Funder types: Other

Identifiers

NCT04135196

13-111

Details and patient eligibility

About

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.

Full 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effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.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).

Enrollment: 102 patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 5 patient groups

Low Magnitude

Experimental group

Description:

voluntary forearm compression by leaning onto the palm of the hand with low target strain

Treatment:

Other: voluntary forearm loading task

High Magnitude

Experimental group

Description:

voluntary forearm compression by leaning onto the palm of the hand with high target strain

Treatment:

Other: voluntary forearm loading task

Low Rate

Experimental group

Description:

voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")

Treatment:

Other: voluntary forearm loading task

High Rate

Experimental group

Description:

voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")

Treatment:

Other: voluntary forearm loading task

Control

No Intervention group

Description:

observation only