NCT02315248

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 197 (actual)
• Sponsor: University of Mississippi Medical Center · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2014-12-11
• Last updated: 2017-02-09

Locations

1 site across 1 country: United States