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

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ClinicalTrials.gov Identifier: NCT04135196
Recruitment Status : Completed
First Posted : October 22, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Northwestern University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bone Loss Other: voluntary forearm loading task Not Applicable

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effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: all data were blinded for analysis
Primary Purpose: Basic Science
Official Title: A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model
Actual Study Start Date : January 14, 2014
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : July 19, 2019

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



Primary Outcome Measures :
  1. Change in UDiBMC [ Time Frame: 12 months ]
    12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT)


Secondary Outcome Measures :
  1. Change in cortical vBMD [ Time Frame: 12 months ]
    12-month change in ultra-distal cortical bone mineral content, measured with quantitative computed tomography (QCT)

  2. Change in trabecular vBMD [ Time Frame: 12 months ]
    12-month change in ultra-distal trabecular bone mineral content, measured with quantitative computed tomography (QCT)

  3. Change in endocortical vBMD [ Time Frame: 12 months ]
    12-month change in ultra-distal endocortical bone mineral content, measured with quantitative computed tomography (QCT)

  4. Change in subregion bone volume [ Time Frame: 12 months ]
    Changes in bone volume in subregions - integral, cortical, endocortical, and trabecular compartments.

  5. 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)

  6. Change in trabecular BV/TV [ Time Frame: measurements repeated at 0, 3, 6, 9, 12, 18, and 24 months from enrollment ]
    Changes in trabecular bone volume fraction (BV/TV) at 3-month intervals, measured with high resolution peripheral quantitative computed tomography (HRpQCT)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 Documents (Full-Text)

Documents provided by Worcester Polytechnic Institute:
Study Protocol  [PDF] July 25, 2018
Statistical Analysis Plan  [PDF] January 12, 2012
Informed Consent Form  [PDF] September 20, 2016


Publications of Results:
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Responsible Party: Worcester Polytechnic Institute
ClinicalTrials.gov Identifier: NCT04135196    
Other Study ID Numbers: 13-111
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Worcester Polytechnic Institute:
bone
adaptation
mechanical stimuli
women
peak bone mass