Bone LossNCT04135196
A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model
A study testing voluntary forearm loading task in people with Bone Loss, run by Worcester Polytechnic Institute.
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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- voluntary forearm loading task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2014to 19 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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)
About this study
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.
Read the 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
- Being tested
- voluntary forearm loading task
- Keywords
- bone, adaptation, mechanical stimuli, women, peak bone mass
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
voluntary forearm loading taskOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Magnitude | Experimental | voluntary forearm compression by leaning onto the palm of the hand with low target strain Receives: Other: voluntary forearm loading task |
| High Magnitude | Experimental | voluntary forearm compression by leaning onto the palm of the hand with high target strain Receives: Other: voluntary forearm loading task |
| Low Rate | Experimental | voluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly") Receives: Other: voluntary forearm loading task |
| High Rate | Experimental | voluntary forearm compression by leaning onto the palm of the hand with high strain rate (task performed "as quickly as possible, with a bump") Receives: Other: voluntary forearm loading task |
| Control | No intervention | observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in UD iBMC
12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Secondary outcomes (13)
Change in UD cBMC
12-month change in ultra-distal cortical bone mineral content, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Change in UD ecBMC
12-month change in ultra-distal endocortical bone mineral content, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Change in UD tBMC
12-month change in ultra-distal trabecular bone mineral content, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Change in UD iBMD
12-month change in ultra-distal integral volumetric bone mineral density, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Change in UD cBMD
12-month change in ultra-distal cortical volumetric bone mineral density, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Change in UD ecBMD
12-month change in ultra-distal endocortical bone mineral density, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Change in UD tBMD
12-month change in ultra-distal trabecular bone mineral density, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Change in UD iBV
12-month change in ultra-distal integral bone volume, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Change in UD cBV
12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Change in UD ecBV
12-month change in ultra-distal cortical bone volume, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Change in UD tBV
12-month change in ultra-distal trabecular bone volume, measured with quantitative computed tomography (QCT)
Measured: baseline and 12 months
Change in Cortical Thickness
Changes in cortical thickness at 3-month intervals, measured with high resolution peripheral quantitative computed tomography (HRpQCT)
Measured: measurements repeated at 0, 3, 6, 9, 12, 18, and 24 months from enrollment
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).
Measured: measurements repeated at 0, 3, 6, 9, and 12 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start14 Jan 2014
- Primary completion29 Jun 2018
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Worcester Polytechnic Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135196
- Sponsor's protocol ID
- 13-111
- Status last verified
- Jan 2023
- First submitted
- 19 Jul 2019
- Last updated
- 18 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29963602Troy 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.
PubMed 32154945
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Human Bone Adaptation Using a Novel in Vivo Loading Model
- ClinicalTrials.gov ID
- NCT04135196
- Acronym / sponsor ID
- 13-111
- Conditions
- Bone Loss
- Keywords
- bone, adaptation, mechanical stimuli, women, peak bone mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Worcester Polytechnic InstituteUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 14 Jan 2014 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Posted 18 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low Magnitude | Experimental | Other: voluntary forearm loading taskvoluntary forearm compression by leaning onto the palm of the hand with low target strain |
| High Magnitude | Experimental | Other: voluntary forearm loading taskvoluntary forearm compression by leaning onto the palm of the hand with high target strain |
| Low Rate | Experimental | Other: voluntary forearm loading taskvoluntary forearm compression by leaning onto the palm of the hand with low strain rate (task performed "slowly and evenly") |
| High Rate | Experimental | Other: voluntary forearm loading taskvoluntary 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 intervention | –observation only |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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]
Key exclusion criteria (20 listed)
- Fracture to wrist <5 years ago
- Wrist Arthritis
- Injury to the non-dominant elbow or shoulder <5 years ago
- Diabetes
- Severe disabling conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| voluntary forearm loading taskvoluntary 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. | Other | High Magnitude, High Rate, Low Magnitude, Low Rate |
Primary outcome
Change in UD iBMC
Time frame: baseline and 12 months
12-month change in ultra-distal integral bone mineral content, measured with quantitative computed tomography (QCT)
13 secondary outcomes
Change in UD cBMC
Time frame: baseline and 12 months
Change in UD ecBMC
Time frame: baseline and 12 months
Change in UD tBMC
Time frame: baseline and 12 months
Change in UD iBMD
Time frame: baseline and 12 months
Change in UD cBMD
Time frame: baseline and 12 months
Change in UD ecBMD
Time frame: baseline and 12 months
Change in UD tBMD
Time frame: baseline and 12 months
Change in UD iBV
Time frame: baseline and 12 months
Change in UD cBV
Time frame: baseline and 12 months
Change in UD ecBV
Time frame: baseline and 12 months
Change in UD tBV
Time frame: baseline and 12 months
Change in Cortical Thickness
Time frame: measurements repeated at 0, 3, 6, 9, 12, 18, and 24 months from enrollment
Change in Trabecular BV/TV
Time frame: measurements repeated at 0, 3, 6, 9, and 12 months from enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29963602Mancuso 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.
- Results publication: PubMed 32154945Troy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing voluntary forearm loading task in people with Bone Loss, run by Worcester Polytechnic Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in UD iBMC (time frame: baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04135196, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.