Age-Related Bone LossNCT03385941
Radio-frequency Identification (RFID) Osteoporosis Pilot Study
An observational study of Age-Related Bone Loss and Bone Loss, Age Related, run by Neva Electromagnetics, LLC.
Trial summary
This examines in-vivo microwave sensing to measure a radio- frequency signal propagating through the wrist and, based on this information, establish a correlation of measured parameters with the integral bone density. Read more about this study
- Who is it for?
- Ages 27 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Age-Related Bone Loss, Bone Loss, Age Related
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2018to 1 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 27 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: We are interested in a population comprised of female patients with and without osteoporosis.
Who may be able to join
- In osteoporotic patients:
- 50-80 years of age
- Established diagnosis of osteoporosis, based on prior dual energy x-ray absorptiometry (DXA) scan with T-score <-2.0 at any site and/or history of fragility fracture
- In healthy controls:
- 27-40 years of age
- Female
Who cannot join
- In osteoporotic patients:
- Current or recent (within 2 years) use of osteoporosis medications including bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators, teriparatide, denosumab, calcitonin, or strontium
- Pregnancy or breastfeeding within the past 2 years
- Any medical or psychiatric condition or situation that would compromise subject safety, informed consent/assent, or data quality
- In healthy controls:
- History of significant cardiac, renal, pulmonary, hepatic, or malignant disease, or current alcohol or illicit drug abuse
Show all 13Show fewer
- Current diagnoses known to effect bone metabolism, including cystic fibrosis, diabetes, osteoporosis, amenorrhea >3 months (in menstruating women who are not taking oral contraceptives or have an IUD), hyperthyroidism, hyperparathyroidism, Paget's disease, kidney stones, chronic inflammatory diseases, malabsorptive disorders, malnutrition or eating disorder, endocrine disorders (growth disorder, Cushing syndrome), prolonged immobility, and skeletal dysplasias
- History one or more pathologic fracture, or greater than four total lifetime non-digital, non-facial fractures
- Cumulative lifetime use of oral glucocorticoids for greater than 2 months
- Current or previous use of medications known to affect bone metabolism including hormone replacement therapy, anti-estrogens, bisphosphonates, calcitonin, lithium, suppressive doses of levothyroxine, or anticonvulsants.
- Pregnancy or breastfeeding within the past 2 years
- BMI less than 18.5 or greater than 30 kg/m2.
- Any medical or psychiatric condition or situation that would compromise subject safety, informed consent/assent, or data quality
About this study
Official title: RFID Osteoporosis Pilot Study
This examines in-vivo microwave sensing to measure a radio- frequency signal propagating through the wrist and, based on this information, establish a correlation of measured parameters with the integral bone density. This radio- frequency device is designed to obtain an integral estimate of bone density (osteoporotic vs normal).
The measurements can be done in three ways. The first method (Method 1) utilizes Received Signal Strength (RSS) of an RFID tag array at 915 megahertz located on the top of the wrist. The transmitting antenna located on the bottom of the wrist is connected to an RFID reader. In that way, the signal travels twice across the wrist: from the reader to the tag and vice versa.
Read more
The second method (Method 2) is to use only one transmitting antenna, connect the transmitting antenna to a portable Network Analyzer and measure the reflection coefficient, S11, of the antenna itself. This method does not imply that the entire signal will travel back and forth through the wrist, although its significant portion will. This method is, however, broadband and allows us to measure antenna resonances, which are very sensitive to the wrist composition.
The third method (Method 3) is to use both transmitting and receiving antennas, connect the antennas to a portable KeySight Network Analyzer and measure the transmission coefficient, S21, of the antenna pair. This method implies that the entire signal will travel through the wrist once. This method is also broadband and allows us to measure decay of the radio-signal in the wrist over a band of frequencies.
The two last methods could be combined together.
- Conditions
- Age-Related Bone Loss, Bone Loss, Age Related
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Osteoporotic | Femal, 50-80 years of age with established diagnosis of osteoporosis, based on prior DXA scan with T-score <-2.0 at any site and/or history of fragility fracture | |
| Non-osteoporotic | Female, 27-40 years of age, no established history of osteoporosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoporosis Screening through the use of a novel On-Body Passive Radio Frequency Identification (RFID) Array and corresponding test bed to include a receiving antenna.
A measurement will be performed to assess if a given patient is or is not at risk of osteoporosis. The measurement is based on the received signal strength or power received from the RFID tag.
Measured: Data from the testing will be available in near real-time and will be collated and reported on within 1 week of the assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start31 Jan 2018 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neva Electromagnetics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385941
- Sponsor's protocol ID
- 2017P001452
- Status last verified
- Jan 2018
- First submitted
- 13 Nov 2017
- Last updated
- 26 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RFID Osteoporosis Pilot Study
- ClinicalTrials.gov ID
- NCT03385941
- Acronym / sponsor ID
- 2017P001452
- Conditions
- Age-Related Bone Loss, Bone Loss, Age Related
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Neva Electromagnetics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Study start
- 31 Jan 2018 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This examines in-vivo microwave sensing to measure a radio- frequency signal propagating through the wrist and, based on this information, establish a correlation of measured parameters with the integral bone density. This radio- frequency device is designed to obtain an integral estimate of bone density (osteoporotic vs normal).
The measurements can be done in three ways. The first method (Method 1) utilizes Received Signal Strength (RSS) of an RFID tag array at 915 megahertz located on the top of the wrist. The transmitting antenna located on the bottom of the wrist is connected to an RFID reader. In that way, the signal travels twice across the wrist: from the reader to the tag and vice versa.
The second method (Method 2) is to use only one transmitting antenna, connect the transmitting antenna to a portable Network Analyzer and measure the reflection coefficient, S11, of the antenna itself. This method does not imply that the entire signal will travel back and forth through the wrist, although its significant portion will. This method is, however, broadband and allows us to measure antenna resonances, which are very sensitive to the wrist composition.
The third method (Method 3) is to use both transmitting and receiving antennas, connect the antennas to a portable KeySight Network Analyzer and measure the transmission coefficient, S21, of the antenna pair. This method implies that the entire signal will travel through the wrist once. This method is also broadband and allows us to measure decay of the radio-signal in the wrist over a band of frequencies.
The two last methods could be combined together.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoporotic | – | –Femal, 50-80 years of age with established diagnosis of osteoporosis, based on prior DXA scan with T-score <-2.0 at any site and/or history of fragility fracture |
| Non-osteoporotic | – | –Female, 27-40 years of age, no established history of osteoporosis |
Who may qualify
- Ages
- 27 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We are interested in a population comprised of female patients with and without osteoporosis.
Key inclusion criteria (6 listed)
- 50-80 years of age
- Established diagnosis of osteoporosis, based on prior dual energy x-ray absorptiometry (DXA) scan with T-score <-2.0 at any site and/or history of fragility fracture
- 27-40 years of age
- Female
Key exclusion criteria (13 listed)
- Current or recent (within 2 years) use of osteoporosis medications including bisphosphonates, hormone replacement therapy, selective estrogen receptor modulators, teriparatide, denosumab, calcitonin, or strontium
- Pregnancy or breastfeeding within the past 2 years
- Any medical or psychiatric condition or situation that would compromise subject safety, informed consent/assent, or data quality
- History of significant cardiac, renal, pulmonary, hepatic, or malignant disease, or current alcohol or illicit drug abuse
- Current diagnoses known to effect bone metabolism, including cystic fibrosis, diabetes, osteoporosis, amenorrhea >3 months (in menstruating women who are not taking oral contraceptives or have an IUD), hyperthyroidism, hyperparathyroidism, Paget's disease, kidney stones, chronic inflammatory diseases, malabsorptive disorders, malnutrition or eating disorder, endocrine disorders (growth disorder, Cushing syndrome), prolonged immobility, and skeletal dysplasias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Osteoporosis Screening through the use of a novel On-Body Passive Radio Frequency Identification (RFID) Array and corresponding test bed to include a receiving antenna.
Time frame: Data from the testing will be available in near real-time and will be collated and reported on within 1 week of the assessment
A measurement will be performed to assess if a given patient is or is not at risk of osteoporosis. The measurement is based on the received signal strength or power received from the RFID tag.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Age-Related Bone Loss
Recruiting
Minimally Invasive Sinus Lift Through the Interradicular Septum
Bone Loss, Bone Loss, Age-related
Recruiting
Lutein, Zeaxathin, and Fish Oil Supplementation
Cognitive Performance, Age-Related Macular Degeneration
Enrolling by invitationPhase 3
Effectiveness of 3D-printed Patient-specific Resorbable Scaffolds for Maxillary Bone Regeneration
Bone Loss, Jaw, Edentulous
Active, not recruiting
Strength Training for Osteoporosis Prevention During Early Menopause
Bone Loss, Bone Loss, Age-related
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?
An observational study of Age-Related Bone Loss and Bone Loss, Age Related, run by Neva Electromagnetics, LLC.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 26 Jan 2018. 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?
Results are not available in the source record.
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?
Osteoporosis Screening through the use of a novel On-Body Passive Radio Frequency Identification (RFID) Array and corresponding test bed to include a receiving antenna. (time frame: Data from the testing will be available in near real-time and will be collated and reported on within 1 week of the assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2018; AzTrials last refreshed its copy on 27 Oct 2026.