NCT00323336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

January 25, 2010

Status Verified

January 1, 2010

Enrollment Period

1.5 years

First QC Date

May 5, 2006

Last Update Submit

January 22, 2010

Conditions

Bone Turnover MarkersOsteoporosis

Eligibility Criteria

Age25 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • pre-menopausal females (25-40 yo)
  • post-menopausal females (55-70 yo)
  • Good systemic health
  • Good oral health

You may not qualify if:

  • arthritis
  • active periodontitis
  • history or actively smoking
  • diabetes
  • HIV positive
  • anti-coagulant therapy
  • bone fracture within the past year
  • pregnancy
  • known metabolic bone disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sreenivas Koka, D.D.S., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2006

First Posted

May 9, 2006

Study Start

May 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

January 25, 2010

Record last verified: 2010-01

Locations

US(1)