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

January 4, 2023 updated by: Worcester Polytechnic Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.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

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Magnitude
voluntary forearm compression by leaning onto the palm of the hand with low target strain
Other: voluntary forearm loading task
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.
Experimental: High Magnitude
voluntary forearm compression by leaning onto the palm of the hand with high target strain
Other: voluntary forearm loading task
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.
Experimental: Low Rate
voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
Other: voluntary forearm loading task
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.
Experimental: High Rate
voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
Other: voluntary forearm loading task
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.
No Intervention: Control
observation only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in UD cBMC
Time Frame: baseline and 12 months
12-month change in ultra-distal cortical bone mineral content, measured with quantitative computed tomography (QCT)
baseline and 12 months
Change in UD ecBMC
Time Frame: baseline and 12 months
12-month change in ultra-distal endocortical bone mineral content, measured with quantitative computed tomography (QCT)
baseline and 12 months
Change in UD tBMC
Time Frame: baseline and 12 months
12-month change in ultra-distal trabecular bone mineral content, measured with quantitative computed tomography (QCT)
baseline and 12 months
Change in UD iBMD
Time Frame: baseline and 12 months
12-month change in ultra-distal integral volumetric bone mineral density, measured with quantitative computed tomography (QCT)
baseline and 12 months
Change in UD cBMD
Time Frame: baseline and 12 months
12-month change in ultra-distal cortical volumetric bone mineral density, measured with quantitative computed tomography (QCT)
baseline and 12 months
Change in UD ecBMD
Time Frame: baseline and 12 months
12-month change in ultra-distal endocortical bone mineral density, measured with quantitative computed tomography (QCT)
baseline and 12 months
Change in UD tBMD
Time Frame: baseline and 12 months
12-month change in ultra-distal trabecular bone mineral density, measured with quantitative computed tomography (QCT)
baseline and 12 months
Change in UD iBV
Time Frame: baseline and 12 months
12-month change in ultra-distal integral bone volume, measured with quantitative computed tomography (QCT)
baseline and 12 months
Change in UD cBV
Time Frame: baseline and 12 months
12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)
baseline and 12 months
Change in UD ecBV
Time Frame: baseline and 12 months
12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)
baseline and 12 months
Change in UD tBV
Time Frame: baseline and 12 months
12-month change in ultra-distal trabecular bone volume, measured with quantitative computed tomography (QCT)
baseline and 12 months
Change in Cortical Thickness
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)
measurements repeated at 0, 3, 6, 9, 12, 18, and 24 months from enrollment
Change in Trabecular BV/TV
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).
measurements repeated at 0, 3, 6, 9, and 12 months from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Worcester Polytechnic Institute

Collaborators

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2014

Primary Completion (Actual)

June 29, 2018

Study Completion (Actual)

July 19, 2019

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

October 18, 2019

First Posted (Actual)

October 22, 2019

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 13-111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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 Bone Loss

Clinical Trials on voluntary forearm loading task

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe