Effects of Low-Dose Doxycycline on Oral Bone Loss

September 1, 2023 updated by: University of Nebraska

Low-Dose Doxycycline Effects on Osteopenic Bone Loss

The primary purpose of this clinical trial is to determine whether low-dose doxycycline can reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and not on hormone replacement therapy (i.e., estrogen deficient).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary purpose of this clinical trial is to determine whether low-dose doxycycline (LDD) can reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and not on hormone replacement therapy (i.e., estrogen deficient). The effects of LDD on alveolar bone height loss, progressive periodontal attachment loss, systemic bone mineral density, gingival crevicular fluid biochemical markers of collagen degradation and bone resorption and serum biomarkers of bone formation, bone resorption and inflammation also will be assessed. In addition, another objective is to determine if the microbial effects obtained with LDD over two years are equivalent to a placebo control. This clinical trial involves two clinical sites: the University of Nebraska Medical Center College of Dentistry and Stony Brook University School of Dental Medicine. A total of 128 postmenopausal osteopenic women with periodontitis between the ages of 45 and 70 at the time of telephone screening will be randomized to LDD or placebo groups and subjects will be followed for two years.

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68583-0740
        • University of Nebraska Medical Center, College of Dentistry
    • New York
      • Stony Brook, New York, United States, 11794-8702
        • Department of Oral Biology and Pathology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects will be female, postmenopausal and not receiving estrogen replacement therapy.
  • Subjects will be 45-70 years old at the time of telephone screening.
  • Subjects will have osteopenia (T-score of -1.0 to -2.5) of the lumbar spine or femoral neck as determined by dual-energy absorptiometry (DEXA) scans.
  • Subjects will have a history of generalized moderate-advanced periodontitis and will be undergoing periodontal maintenance.
  • Subjects will be in good general health and willing to sign the IRB-approved consent form.

Exclusion Criteria:

  • Subjects will not have an allergy or hypersensitivity to tetracyclines.
  • Subjects will not have diseases or take medications that affect the inflammatory or immune responses (e.g., chronic use of non-steroidal anti-inflammatory drugs) or bone remodeling (e.g., drugs such as prescription estrogens, bisphosphonates, calcitonin or steroids).
  • Subjects will not have any medical condition requiring antibiotic premedication (e.g., prosthetic heart valves, prosthetic joints, and mitral valve prolapse with regurgitation) for routine dental therapy.
  • Subjects cannot have diabetes mellitus.
  • Subjects cannot have had active periodontal therapy (quadrant scaling and root planing or periodontal surgery) within the past year.
  • Subjects cannot have osteoporosis (T-score greater than -2.5) of the lumbar spine or femoral neck.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Subjects in the placebo group took a placebo look-alike twice daily for two years.
Other Names:
  • sugar pill
Experimental: low-dose doxycycline
low-dose doxycycline (20 mg doxycycline hyclate)
Drug: 20 mg doxycycline hyclate
Subjects in the LDD group took 20 mg doxycycline hyclate tablets twice daily for two years
Other Names:
  • antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alveolar Bone Density
Time Frame: Baseline, one-year and two-year visits
Alveolar bone density changes assessed by radiographic absorptiometry and computer-assisted densitometric image analysis.
Baseline, one-year and two-year visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Jeffrey B Payne, DDS, UNMC College of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2002

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

August 1, 2003

First Submitted That Met QC Criteria

August 4, 2003

First Posted (Estimated)

August 5, 2003

Study Record Updates

Last Update Posted (Estimated)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0511-00-FB
  • R01DE012872 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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