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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00323336
Collaborator
(none)
100
Enrollment
1
Location
18
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Time Perspective:
    Prospective
    Official Title:
    Salivary Markers of Bone Turnover Compared to Urine and Blood
    Study Start Date :
    May 1, 2006
    Actual Primary Completion Date :
    Nov 1, 2007
    Actual Study Completion Date :
    Nov 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      25 Years to 70 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      Yes
      Inclusion:

      • 50 pre-menopausal females (25-40 yo)

      • 50 post-menopausal females (55-70 yo)

      • Good systemic health

      • Good oral health

      Exclusion:

      • arthritis

      • active periodontitis

      • history or actively smoking

      • diabetes

      • HIV positive

      • anti-coagulant therapy

      • bone fracture within the past year

      • pregnancy

      • known metabolic bone disease

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Mayo Clinic Rochester Minnesota United States 55905

      Sponsors and Collaborators

      • Mayo Clinic

      Investigators

      • Principal Investigator: Sreenivas Koka, D.D.S., Ph.D., Mayo Clinic

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00323336
      Other Study ID Numbers:
      • 77-05
      First Posted:
      May 9, 2006
      Last Update Posted:
      Jan 25, 2010
      Last Verified:
      Jan 1, 2010
      Additional relevant MeSH terms:
      Osteoporosis

      Study Results

      No Results Posted as of Jan 25, 2010