NCT04135196

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

Completed NA Results posted Last updated 18 October 2023

What this trial tests

NA trial testing voluntary forearm loading task in Bone Loss in 102 participants. Completed in 19 July 2019.

Timeline

14 January 2014

Primary endpoint
29 June 2018

19 July 2019

Quick facts

Lead sponsor	Worcester Polytechnic Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	102
Start date	14 January 2014
Primary completion	29 June 2018
Estimated completion	19 July 2019

Drugs / interventions tested

• voluntary forearm loading task

Conditions studied

• Bone Loss — all drugs for Bone Loss →

Sponsor

Worcester Polytechnic Institute

Who can join

Adults 21 to 40, female only, with Bone Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in UD iBMC Primary · baseline and 12 months

12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	0.0049	± 0.0146
High Magnitude	-0.0020	± 0.0165
Low Rate	0.0252	± 0.0206
High Rate	0.0309	± 0.0211
Control	-0.0106	± 0.0241

Change in UD cBMC Secondary · baseline and 12 months

12-month change in ultra-distal cortical bone mineral content, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	0.0037	± 0.0127
High Magnitude	-0.0001	± 0.0101
Low Rate	0.0139	± 0.0124
High Rate	0.0166	± 0.0176
Control	0.0024	± 0.0243

Change in UD ecBMC Secondary · baseline and 12 months

12-month change in ultra-distal endocortical bone mineral content, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	0.0007	± 0.0173
High Magnitude	0.0001	± 0.0151
Low Rate	0.0286	± 0.0240
High Rate	0.0287	± 0.0274
Control	-0.0004	± 0.0311

Change in UD tBMC Secondary · baseline and 12 months

12-month change in ultra-distal trabecular bone mineral content, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	0.0018	± 0.0082
High Magnitude	-0.0021	± 0.0067
Low Rate	0.0072	± 0.0092
High Rate	0.0112	± 0.0106
Control	-0.0048	± 0.0107

Change in UD iBMD Secondary · baseline and 12 months

12-month change in ultra-distal integral volumetric bone mineral density, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	-0.0008	± 0.0024
High Magnitude	-0.0007	± 0.0027
Low Rate	0.0072	± 0.0027
High Rate	0.0071	± 0.0035
Control	-0.0014	± 0.0047

Change in UD cBMD Secondary · baseline and 12 months

12-month change in ultra-distal cortical volumetric bone mineral density, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	-0.0025	± 0.0068
High Magnitude	-0.0015	± 0.0073
Low Rate	0.0073	± 0.0058
High Rate	0.0036	± 0.0081
Control	0.0029	± 0.0101

Change in UD ecBMD Secondary · baseline and 12 months

12-month change in ultra-distal endocortical bone mineral density, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	-0.0031	± 0.0102
High Magnitude	-0.0012	± 0.0080
Low Rate	0.0141	± 0.0105
High Rate	0.0122	± 0.0116
Control	0.0005	± 0.0141

Change in UD tBMD Secondary · baseline and 12 months

12-month change in ultra-distal trabecular bone mineral density, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	0.0006	± 0.0028
High Magnitude	-0.0013	± 0.0036
Low Rate	0.0050	± 0.0043
High Rate	0.0071	± 0.0053
Control	-0.0029	± 0.0046

Change in UD iBV Secondary · baseline and 12 months

12-month change in ultra-distal integral bone volume, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	0.027	± 0.061
High Magnitude	0.003	± 0.055
Low Rate	-0.011	± 0.049
High Rate	0.012	± 0.066
Control	-0.026	± 0.068

Change in UD cBV Secondary · baseline and 12 months

12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	0.014	± 0.028
High Magnitude	0.003	± 0.028
Low Rate	0.016	± 0.035
High Rate	0.031	± 0.038
Control	0.002	± 0.056

Change in UD ecBV Secondary · baseline and 12 months

12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	0.018	± 0.029
High Magnitude	0.008	± 0.030
Low Rate	-0.0003	± 0.025
High Rate	0.009	± 0.028
Control	-0.007	± 0.030

Change in UD tBV Secondary · baseline and 12 months

12-month change in ultra-distal trabecular bone volume, measured with quantitative computed tomography (QCT)

Group	Value	95% CI
Low Magnitude	0.006	± 0.029
High Magnitude	-0.004	± 0.023
Low Rate	-0.003	± 0.023
High Rate	0.006	± 0.034
Control	-0.011	± 0.033

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected for each participant for the 2-year study period following enrollment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Low Magnitude

Serious: 0/21 (0%)

Deaths: 0/21

High Magnitude

Serious: 0/24 (0%)

Deaths: 0/24

Low Rate

Serious: 0/21 (0%)

Deaths: 0/21

High Rate

Serious: 0/20 (0%)

Deaths: 0/20

Control

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (5 terms — click to expand)

Reaction	System	Low Magnitude	High Magnitude	Low Rate	High Rate	Control
Temporary Wrist Soreness	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Arm Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Other injury or pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—
Wrist Bump	Musculoskeletal and connective tissue disorders	—	—	—	—	—

Data from ClinicalTrials.gov NCT04135196 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bone Adaptation in Adult Women Is Related to Loading Dose: A 12-Month Randomized Controlled Trial.
   Troy KL, Mancuso ME, Johnson JE, Wu Z, et al · · 2020 · cited 25× · PMID 32154945 · DOI 10.1002/jbmr.3999
2. Dominant and nondominant distal radius microstructure: Predictors of asymmetry and effects of a unilateral mechanical loading intervention.
   Troy KL, Mancuso ME, Johnson JE, Butler TA, et al · · 2021 · cited 3× · PMID 33786342 · DOI 10.1016/j.bonr.2021.101012