A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model
1 other identifier
interventional
102
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2018
CompletedFirst Submitted
Initial submission to the registry
July 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedResults Posted
Study results publicly available
October 18, 2023
CompletedOctober 18, 2023
January 1, 2023
4.5 years
July 19, 2019
March 26, 2021
January 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Change in UD cBMC
baseline and 12 months
Change in UD ecBMC
baseline and 12 months
Change in UD tBMC
baseline and 12 months
Change in UD iBMD
baseline and 12 months
Change in UD cBMD
baseline and 12 months
- +8 more secondary outcomes
Study Arms (5)
Low Magnitude
EXPERIMENTALvoluntary forearm compression by leaning onto the palm of the hand with low target strain
High Magnitude
EXPERIMENTALvoluntary forearm compression by leaning onto the palm of the hand with high target strain
Low Rate
EXPERIMENTALvoluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly")
High Rate
EXPERIMENTALvoluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump")
Control
NO INTERVENTIONobservation only
Interventions
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.
Eligibility Criteria
You may qualify if:
- Female
- Age 21-40
- Body Mass Index \[18-29\]
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Worcester Polytechnic Institutelead
- Northwestern Universitycollaborator
Related 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: 10.1016/j.bonr.2018.04.001. eCollection 2018 Jun.
PMID: 29963602RESULTTroy 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.
PMID: 32154945RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Karen Troy
- Organization
- Worcester Polytechnic Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- all data were blinded for analysis
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2019
First Posted
October 22, 2019
Study Start
January 14, 2014
Primary Completion
June 29, 2018
Study Completion
July 19, 2019
Last Updated
October 18, 2023
Results First Posted
October 18, 2023
Record last verified: 2023-01