Effects of Low-Dose Doxycycline on Oral Bone Loss

Condition(s) targeted: Periodontitis

Intervention: 20 mg doxycycline hyclate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Dental and Craniofacial Research (NIDCR)

Official(s) and/or principal investigator(s):
Jeffrey B Payne, Dr, Principal Investigator, Affiliation: UNMC College of Dentistry

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).

Official title: Low-Dose Doxycycline Effects on Osteopenic Bone Loss

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: alveolar bone density

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.

Minimum age: 45 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

Inclusion:

- 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:

- 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.

UNMC College of Dentistry, Lincoln, Nebraska 68583-0740, United States

Department of Oral Biology and Pathology, Stony Brook, New York 11794-8702, United States

Starting date: June 2002
Ending date: October 2005
Last updated: April 9, 2008