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

NCT ID: NCT04135196

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-14
• Study Completion Date: 2019-07-19

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effect of withdrawing mechanical signals, by measuring bone structure during the 12 months after the intervention is withdrawn.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

Conditions

Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Low Magnitude

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

Group Type: EXPERIMENTAL

voluntary forearm loading task

Intervention Type: OTHER

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.

High Magnitude

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

Group Type: EXPERIMENTAL

voluntary forearm loading task

Intervention Type: OTHER

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.

Low Rate

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

Group Type: EXPERIMENTAL

voluntary forearm loading task

Intervention Type: OTHER

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.

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")

Group Type: EXPERIMENTAL

voluntary forearm loading task

Intervention Type: OTHER

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.

Control

observation only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Northwestern University

OTHER

Sponsor Role: collaborator

Worcester Polytechnic Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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: 10.1016/j.bonr.2018.04.001. eCollection 2018 Jun.

Reference Type: RESULT

PMID: 29963602 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32154945 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

13-111

Identifier Type: -

Identifier Source: org_study_id