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

Completed

Conditions studied: Osteoporosis

In brief

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.

Key facts

Study ID

NCT02315248

Run by

University of Mississippi Medical Center

People needed

197

Starts

2014-12-01

Expected to finish

2016-08-01

Last updated by the study team

2017-02-09

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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