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

NCT02315248 | Completed

• 1 other identifier: 2014-0108
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

bone density

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Validation of human saliva sample analyzer LFA technique against ELISA (gold standard)

  20 months

Interventions

Quantitative computed tomography scan for bone density analysis RADIATION

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

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.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary biosamples will be stored for assaying osteocalcin (OC) and deoxypyridinoline (DPD) levels

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Manal Bashay, MS

  Intelligent Optical Systems Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 11, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 9, 2017

Record last verified: 2014-12

Locations

US (1)