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

Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04135196
• Other study ID #: 13-111
• Status: Completed
• Phase: N/A
• Start date: January 14, 2014
• Est. completion date: July 19, 2019

Study information

• Verified date: January 2023
• Source: Worcester Polytechnic Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.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

• Status: Completed
• Enrollment: 102
• Est. completion date: July 19, 2019
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bone Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Worcester Polytechnic Institute	Northwestern University

References & Publications (2)

Mancuso ME, Johnson JE, Ahmed SS, Butler TA, Troy KL. Distal radius microstructure and finite element bone strain are related to site-specific mechanical loading and areal bone mineral density in premenopausal women. Bone Rep. 2018 Apr 14;8:187-194. doi: — View Citation

Troy KL, Mancuso ME, Johnson JE, Wu Z, Schnitzer TJ, Butler TA. Bone Adaptation in Adult Women Is Related to Loading Dose: A 12-Month Randomized Controlled Trial. J Bone Miner Res. 2020 Jul;35(7):1300-1312. doi: 10.1002/jbmr.3999. Epub 2020 Mar 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in UD iBMC	12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in UD cBMC	12-month change in ultra-distal cortical bone mineral content, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in UD ecBMC	12-month change in ultra-distal endocortical bone mineral content, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in UD tBMC	12-month change in ultra-distal trabecular bone mineral content, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in UD iBMD	12-month change in ultra-distal integral volumetric bone mineral density, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in UD cBMD	12-month change in ultra-distal cortical volumetric bone mineral density, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in UD ecBMD	12-month change in ultra-distal endocortical bone mineral density, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in UD tBMD	12-month change in ultra-distal trabecular bone mineral density, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in UD iBV	12-month change in ultra-distal integral bone volume, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in UD cBV	12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in UD ecBV	12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in UD tBV	12-month change in ultra-distal trabecular bone volume, measured with quantitative computed tomography (QCT)	baseline and 12 months
Secondary	Change in Cortical Thickness	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
Secondary	Change in Trabecular BV/TV	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