Osteoporosis Clinical Trial
Official title:
Salivary-based Bone Loss Marker Detection Platform for Point-of-care Screening - Phase II Study
Verified date | December 2014 |
Source | University of Mississippi Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 197 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Mississippi Medical Center | Jackson | Mississippi |
Lead Sponsor | Collaborator |
---|---|
University of Mississippi Medical Center | National Institute of Dental and Craniofacial Research (NIDCR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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