Markers of Bone Turnover in Saliva and How This Compares to Urine and Blood

Completed

• Conditions: Bone Turnover Markers; Osteoporosis

• Registration Number: NCT00323336
• Lead Sponsor: Mayo Clinic

Brief Summary

Study is being done to determine if it is possible to use saliva to measure bone specific proteins and predict bone turnover which could be used in the treatment of osteoporosis.

Detailed Description

Prevention and treatment of osteoporosis require sensitive and specific assays of bone turnover. Presently, serum or urinary assessments are used. However, the development of other procedures that are more patient-convenient, non-invasive and cost-efficient would significantly facilitate a clinician's ability to determine bone turnover. The objective of this application is to determine the feasibility of using saliva for this measurement. We will compare serum, urinary and salivary levels in 50 pre- and 50 post-menopausal women. Markers to be measured are bone alkaline phosphatase, osteocalcin, procollagen type propepties hydroxypyridinium crosslinks of collagen and crosslinked collagen telopeptides. Collection of saliva, serum and urine will be done at a single visit. We expect to observe reasonable good correlation between serum and saliva levels and poorer correlation between urine and saliva levels.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-05
• Study First Submitted QC: 2006-05-05
• Study First Posted: 2006-05-09
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-22
• Last Update Posted: 2010-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States