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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00323336
First received: May 5, 2006
Last updated: January 22, 2010
Last verified: January 2010
History of Changes
  Purpose

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
Bone Turnover Markers
Osteoporosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Salivary Markers of Bone Turnover Compared to Urine and Blood

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Enrollment: 100
Study Start Date: May 2006
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

The subject population will be limited to pre-menopausal and post-menopausal females who are in good systemic health in an attempt to determine whether salivary levels of bone turnover markers hold valuable promise as a replacement or partner biofluid for serum and/or urine. In addition, proper selection of the subject population will minimize the effect of confounding variables. The specific inclusion criteria and exclusion criteria are listed below.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323336

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Sreenivas Koka, D.D.S., Ph.D. Mayo Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00323336     History of Changes
Other Study ID Numbers: 77-05
Study First Received: May 5, 2006
Last Updated: January 22, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 22, 2013