OsteopeniaNCT03688282

Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2

A study testing Wearable vibration belt in people with Osteopenia, run by Theranova, L.L.C. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The wearable vibration device aims to consistently deliver vibrations directly to the hip and spine and allowing use during many everyday activities. We propose that demonstrating higher rates of compliance and consistent delivery of optimal force, with accelerometer feedback, will provide a superior alternative to… Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Osteopenia
What is being tested?: Wearable vibration belt
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 11 Jul 2018to 17 Apr 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 Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Female
Last menstrual period at least one year prior and not more than eight years prior.
19 years of age and older.
BMD T-score at or above -2.49 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
Ambulatory (can walk or stand without an assistive device for a minimum of 30 minutes).
Able to understand spoken and written English.
Capable and willing to follow all study-related procedures.

Who cannot join

BMD T-score at or below -2.5 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
A 10-year probability of hip fracture of > 3% or major fracture of > 20% based on results of DXA using the FRAX tool (see attached).
Weight > 300 lbs.
Are currently taking or have taken bisphosphonates within the past 12 months, estrogen replacement therapy, or drugs affecting bone such as tamoxifen or aromatase inhibitors within the past 6 months.
Active cancer or cancer treatment.
Any change in exercise in the past 3 months.

Show all 11Show fewer

Fractures or major surgery within the past 6 months.
Medical Implants (excluding dental implants).
Diagnosed with Paget's disease, heart disease, uncontrolled hypertension, renal disease, chronic fatigue syndrome, herniated disc, severe peripheral neuropathy, severe osteoarthritis.
Any bleeding disorder or treatment with a blood thinning medication within the last 2 years.
Hip circumference is greater than 42 inches

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Nebraska Medical Center
Omaha, Nebraska, 68198

Other trials in United States

About this study

Read the detailed description

The goal of this study is to demonstrate that postmenopausal women will tolerate our device, have high rates of compliance with the study protocol, receive consistently therapeutic levels of vibration and see significant effects on bone turnover based on plasma markers of bone anabolism and catabolism.

The anticipated outcomes from serum draws are an improvement in two bone turnover markers after a 30 minute treatment with the WVD.

Conditions: Osteopenia
Being tested: Wearable vibration belt, Sham, wearing belt
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.

Wearable vibration beltDevice
The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
Sham, wearing beltDevice
The device is worn, for a specified time. It will not be turned on during this period. It is only sham.

Study groups in NCT03688282
Study group	Role	What they receive
Sham Wearable belt	Sham comparator	Device will be worn but not turned on for 30 minutes. Receives: Device: Sham, wearing belt
Wearable vibration belt (30)	Experimental	Device will be worn and turned on for 30 minute treatment. Receives: Device: Wearable vibration belt

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Blood-based Biomarker of Bone Loss
Percent change in NTX, a biomarker of bone loss activity measured in the blood. Percent change in NTX was determined from Baseline (pre-treatment) to 30-minutes post-treatment for the sham treatment and the active treatments. The difference in percent change was then compared between active and sham treatments.
Measured: Baseline and 30 minutes after completing the 30-minute treatment session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 201817 Apr 2019

First posted28 Sep 2018
Study start11 Jul 2018
Primary completion29 Nov 2018
Study completion17 Apr 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.
Other trials for OsteopeniaStudies 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: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03688282
Sponsor's protocol ID: CRD-09-1105
Status last verified: Nov 2020
First submitted: 19 Sep 2018
Last updated: 27 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteopenia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Wearable Vibration Device to Prevent Bone Loss in Postmenopausal Women--Aim 2
ClinicalTrials.gov ID: NCT03688282
Acronym / sponsor ID: CRD-09-1105
Conditions: Osteopenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Theranova, L.L.C.Industry (pharma, biotech, devices)
Collaborators: University of Nebraska
Study start: 11 Jul 2018 (actual)
Primary completion: 29 Nov 2018 (actual)
Study completion: 17 Apr 2019 (actual)
First posted: 28 Sep 2018 (actual)
Results: Posted 27 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The anticipated outcomes from serum draws are an improvement in two bone turnover markers after a 30 minute treatment with the WVD.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Sham Wearable belt	Sham comparator	Device: Sham, wearing beltDevice will be worn but not turned on for 30 minutes.
Wearable vibration belt (30)	Experimental	Device: Wearable vibration beltDevice will be worn and turned on for 30 minute treatment.

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Female
Last menstrual period at least one year prior and not more than eight years prior.
19 years of age and older.
BMD T-score at or above -2.49 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
Ambulatory (can walk or stand without an assistive device for a minimum of 30 minutes).

Key exclusion criteria (11 listed)

BMD T-score at or below -2.5 at the total hip and L1-L4 spine skeletal sites as measured by DXA.
A 10-year probability of hip fracture of > 3% or major fracture of > 20% based on results of DXA using the FRAX tool (see attached).
Weight > 300 lbs.
Are currently taking or have taken bisphosphonates within the past 12 months, estrogen replacement therapy, or drugs affecting bone such as tamoxifen or aromatase inhibitors within the past 6 months.
Active cancer or cancer treatment.

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
Wearable vibration beltThe device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.	Device	Wearable vibration belt (30)
Sham, wearing beltThe device is worn, for a specified time. It will not be turned on during this period. It is only sham.	Device	Sham Wearable belt

Primary outcome

Percent Change in Blood-based Biomarker of Bone Loss
Time frame: Baseline and 30 minutes after completing the 30-minute treatment session
Percent change in NTX, a biomarker of bone loss activity measured in the blood. Percent change in NTX was determined from Baseline (pre-treatment) to 30-minutes post-treatment for the sham treatment and the active treatments. The difference in percent change was then compared between active and sham treatments.

Results and safety

Results posted to the registry on 27 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham & 30 Minute Treatment	18	17

Primary outcome: Percent Change in Blood-based Biomarker of Bone Loss

Time frame: Baseline and 30 minutes after completing the 30-minute treatment session. Mean (Standard Deviation). Unit: Percent change

Measure	Sham Treatment Session n = 17	Active Treatment Session n = 17
Value	8.8 (7.6)	-5.4 (8.8)

Sham Treatment Session vs Active Treatment Session: p <0.001, t-test, 2 sided

Population analysed: All subjects that completed both treatment sessions

Adverse events

Time frame: Study duration (2 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham Treatment Session	0 of 18 (0%)	0 of 18 (0%)	0 of 18
Active Treatment Session	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Active, not recruitingObservational study
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Active, not recruiting
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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wearable vibration belt in people with Osteopenia, run by Theranova, L.L.C. at 1 site in United States.

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 11 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 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 27 Apr 2021). 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?

Percent Change in Blood-based Biomarker of Bone Loss (time frame: Baseline and 30 minutes after completing the 30-minute treatment session). 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 NCT03688282.

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 27 Apr 2021.