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

Osteoporosis Clinical Trial

Official title:

Salivary Markers of Bone Turnover Compared to Urine and Blood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00323336
• Other study ID #: 77-05
• Status: Completed
• Phase: N/A
• First received: May 5, 2006
• Last updated: January 22, 2010
• Start date: May 2006
• Est. completion date: November 2007

Study information

• Verified date: January 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Turnover Markers
• Osteoporosis

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,