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

NCT ID: NCT00323336

Last Updated: 2010-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-11-30

Brief Summary

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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

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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.

Conditions

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Bone Turnover Markers Osteoporosis

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Principal Investigators

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Sreenivas Koka, D.D.S., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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77-05

Identifier Type: -

Identifier Source: org_study_id

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