OsteoporosisNCT02315248
Salivary-based Bone Loss Marker Detection Platform for Point-of-care Screening - Phase II Study
An observational study of Osteoporosis, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to validate a human saliva sample analyzer technique designed to screen for low bone density and osteoporosis. The analyzer technique is meant to be a simple, noninvasive, easy-to-use, cost-effective, and routine means of diagnosing bone turnover using a point-of-care device that monitors… Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Quantitative computed tomography scan for bone density analysis
- Type of treatment
- Surgery or procedure
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Aug 2016
- 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 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of asymptomatic women 50 years of age or older who present for a screening mammogram and are at risk for low bone density or osteoporosis (N=200).
Who may be able to join
- Female ≥50 years of age and referred for standard of care screening mammogram.
- Ability to provide salivary samples.
- Ability to lie flat on the CT scanner.
- Ability and willingness to provide signed and dated informed consent.
Who cannot join
- Any known bone metabolism disorder (other than osteoporosis or low bone density) including sickle cell disease, current neoplastic disease, metastatic disease or any neoplastic disease involving the bones (including leukemia), or Paget's disease.
- Body weight exceeds the weight limit (>400lbs) of the CT table.
- Vulnerable subjects including pregnant women and prisoners.
- Subjects who have had prior QCT imaging to measure bone density.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
The purpose of this study is to validate a human saliva sample analyzer technique designed to screen for low bone density and osteoporosis. The analyzer technique is meant to be a simple, noninvasive, easy-to-use, cost-effective, and routine means of diagnosing bone turnover using a point-of-care device that monitors salivary markers of bone turnover in a screening patient population that is at risk for low bone density or osteoporosis.
Read the detailed description
Primary objective: To validate the performance of human saliva sample analyzer LFA technique against bone density as measured by quantitative computed tomography (QCT).
Secondary objective: To validate the performance of human saliva sample analyzer LFA technique against salivary ELISA method (gold standard).
Number of sites: Single site at the University of Mississippi Medical Center
The purpose of this prospective Phase II observational study is to further refine a proprietary device and test it in a screening population composed of women 50 years of age or older who are at risk for low bone density or osteoporosis (N=200). After screening for inclusion and exclusion criteria and obtaining informed consent, participants will provide a salivary sample and will undergo quantitative computed tomography (QCT) at the same visit (Visit 1, Day 0). No additional visits are planned. Bone mineral density (BMD) will be measured by diagnostic radiologists using QCT techniques and serve as the gold standard for the study. Salivary samples will be analyzed by a lab at UMMC for concentrations of osteocalcin (OC) and deoxypyridinoline (DPD) using enzyme-linked immunosorbent assay (ELISA) techniques, while blinded to BMD measurements. De-identified and coded salivary sample will be shipped to IOS who will measure concentrations of OC and DPD using lateral flow assay (LFA), while blinded to BMD measurements.
- Conditions
- Osteoporosis
- Being tested
- Quantitative computed tomography scan for bone density analysis
- Keywords
- bone density
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative computed tomography scan for bone density analysisRadiation
A low radiation dose quantitative computed tomography (QCT) of the spine (L1 and L2) and the hips will be performed to measure bone density in the spine and hips.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of human saliva sample analyzer LFA technique against measured bone density
To validate the performance of human saliva sample analyzer LFA technique against bone density as measured by quantitative computed tomography (QCT).
Measured: 20 months
Secondary outcomes (1)
Validation of human saliva sample analyzer LFA technique against ELISA (gold standard)
To validate the performance of human saliva sample analyzer LFA technique against salivary ELISA method (gold standard).
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Manal Bashay, MS, Principal investigator, Intelligent Optical Systems Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315248
- Sponsor's protocol ID
- 2014-0108
- Status last verified
- Dec 2014
- First submitted
- 9 Dec 2014
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary-based Bone Loss Marker Detection Platform for Point-of-care Screening - Phase II Study
- ClinicalTrials.gov ID
- NCT02315248
- Acronym / sponsor ID
- 2014-0108
- Conditions
- Osteoporosis
- Keywords
- bone density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Dec 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Dec 2014 (estimated)
- 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.
The purpose of this study is to validate a human saliva sample analyzer technique designed to screen for low bone density and osteoporosis. The analyzer technique is meant to be a simple, noninvasive, easy-to-use, cost-effective, and routine means of diagnosing bone turnover using a point-of-care device that monitors salivary markers of bone turnover in a screening patient population that is at risk for low bone density or osteoporosis.
Detailed description
Primary objective: To validate the performance of human saliva sample analyzer LFA technique against bone density as measured by quantitative computed tomography (QCT).
Secondary objective: To validate the performance of human saliva sample analyzer LFA technique against salivary ELISA method (gold standard).
Number of sites: Single site at the University of Mississippi Medical Center
The purpose of this prospective Phase II observational study is to further refine a proprietary device and test it in a screening population composed of women 50 years of age or older who are at risk for low bone density or osteoporosis (N=200). After screening for inclusion and exclusion criteria and obtaining informed consent, participants will provide a salivary sample and will undergo quantitative computed tomography (QCT) at the same visit (Visit 1, Day 0). No additional visits are planned. Bone mineral density (BMD) will be measured by diagnostic radiologists using QCT techniques and serve as the gold standard for the study. Salivary samples will be analyzed by a lab at UMMC for concentrations of osteocalcin (OC) and deoxypyridinoline (DPD) using enzyme-linked immunosorbent assay (ELISA) techniques, while blinded to BMD measurements. De-identified and coded salivary sample will be shipped to IOS who will measure concentrations of OC and DPD using lateral flow assay (LFA), while blinded to BMD measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of asymptomatic women 50 years of age or older who present for a screening mammogram and are at risk for low bone density or osteoporosis (N=200).
Key inclusion criteria (4 listed)
- Female ≥50 years of age and referred for standard of care screening mammogram.
- Ability to provide salivary samples.
- Ability to lie flat on the CT scanner.
- Ability and willingness to provide signed and dated informed consent.
Key exclusion criteria (4 listed)
- Any known bone metabolism disorder (other than osteoporosis or low bone density) including sickle cell disease, current neoplastic disease, metastatic disease or any neoplastic disease involving the bones (including leukemia), or Paget's disease.
- Body weight exceeds the weight limit (>400lbs) of the CT table.
- Vulnerable subjects including pregnant women and prisoners.
- Subjects who have had prior QCT imaging to measure bone density.
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 |
|---|---|---|
| Quantitative computed tomography scan for bone density analysisA low radiation dose quantitative computed tomography (QCT) of the spine (L1 and L2) and the hips will be performed to measure bone density in the spine and hips. | Radiation | – |
Primary outcome
Validation of human saliva sample analyzer LFA technique against measured bone density
Time frame: 20 months
To validate the performance of human saliva sample analyzer LFA technique against bone density as measured by quantitative computed tomography (QCT).
1 secondary outcome
Validation of human saliva sample analyzer LFA technique against ELISA (gold standard)
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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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.
Manal Bashay, MS principal investigator
Intelligent Optical Systems Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by University of Mississippi Medical Center 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 4 inclusion and 4 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 9 Feb 2017. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Validation of human saliva sample analyzer LFA technique against measured bone density (time frame: 20 months). 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 9 Feb 2017.