Effects of Low-Dose Doxycycline on Oral Bone Loss

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
• Treatments: Doxycycline

Criteria

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.