Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Salivary-based Bone Loss Marker Detection Platform for Point-of-care Screening - Phase II Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02315248
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : February 9, 2017
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of Mississippi Medical Center

Brief 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 salivary markers of bone turnover in a screening patient population that is at risk for low bone density or osteoporosis.

Condition or disease Intervention/treatment
Osteoporosis Radiation: Quantitative computed tomography scan for bone density analysis

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 197 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Salivary-based Bone Loss Marker Detection Platform for Point-of-care Screening - Phase II Study
Study Start Date : December 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Radiation: Quantitative computed tomography scan for bone density analysis
    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.


Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Validation of human saliva sample analyzer LFA technique against ELISA (gold standard) [ Time Frame: 20 months ]
    To validate the performance of human saliva sample analyzer LFA technique against salivary ELISA method (gold standard).


Biospecimen Retention:   Samples Without DNA
Salivary biosamples will be stored for assaying osteocalcin (OC) and deoxypyridinoline (DPD) levels


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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).
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315248


Locations
Layout table for location information
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Layout table for investigator information
Principal Investigator: Manal Bashay, MS Intelligent Optical Systems Inc.

Layout table for additonal information
Responsible Party: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT02315248     History of Changes
Other Study ID Numbers: 2014-0108
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: December 2014

Keywords provided by University of Mississippi Medical Center:
bone density

Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases