Low-Dose Doxycycline Effects on Osteopenic Bone Loss

0511-00-FB

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).

2002-06-01

2005-10-01

2005-10-01

Completed

Early phase I

128

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.

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2023-09-06