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

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 197

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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).

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	20 months

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Manal Bashay, MS, Intelligent Optical Systems Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Estimate): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: bone density
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: 2014-0108