N/A N=102 Randomized Single-blind Basic Science

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

Bone Loss

Bottom Line

View on ClinicalTrials.gov: NCT04135196 ↗

Enrolled (actual)

102

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: Primary: Change in UD iBMC — 0.0049; -0.0020; 0.0252; 0.0309 g — p=0.119

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: voluntary forearm loading task (Other)
Age: Adult · 21+ yrs
Sex: Female
Sponsor: Worcester Polytechnic Institute
Primary completion: Jun 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in UD iBMC	0.0049; -0.0020; 0.0252; 0.0309; -0.0106	0.119
SECONDARY Change in UD cBMC	0.0037; -0.0001; 0.0139; 0.0166; 0.0024	0.809
SECONDARY Change in UD ecBMC	0.0007; 0.0001; 0.0286; 0.0287; -0.0004	0.991
SECONDARY Change in UD tBMC	0.0018; -0.0021; 0.0072; 0.0112; -0.0048	0.153
SECONDARY Change in UD iBMD	-0.0008; -0.0007; 0.0072; 0.0071; -0.0014	0.840
SECONDARY Change in UD cBMD	-0.0025; -0.0015; 0.0073; 0.0036; 0.0029	0.202
SECONDARY Change in UD ecBMD	-0.0031; -0.0012; 0.0141; 0.0122; 0.0005	0.697
SECONDARY Change in UD tBMD	0.0006; -0.0013; 0.0050; 0.0071; -0.0029	0.073
SECONDARY Change in UD iBV	0.027; 0.003; -0.011; 0.012; -0.026	0.101
SECONDARY Change in UD cBV	0.014; 0.003; 0.016; 0.031; 0.002	0.676
SECONDARY Change in UD ecBV	0.018; 0.008; -0.0003; 0.009; -0.007	0.096
SECONDARY Change in UD tBV	0.006; -0.004; -0.003; 0.006; -0.011	0.332
SECONDARY Change in Cortical Thickness	0.001; -0.012; 0.009; 0.032; -0.004; -0.003	—
SECONDARY Change in Trabecular BV/TV	-0.0006; 0.0003; -0.0020; 0.0002; -0.0014; 0.0006	>0.05

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.

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 1 time/week
Alcohol >4 drinks/day
Pregnancy or lactation 2 times/month
Low calcium intake (avoiding dairy products without taking calcium supplement)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04135196). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.