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Home > "E" Clinical Trials Conditions > Effects of Low-Dose Doxycycline on Oral Bone Loss  Effects of Low-Dose Doxycycline on Oral Bone Loss
Effects of Low-Dose Doxycycline on Oral Bone Loss
For Condition: Periodontitis,Osteopenia
Status: No longer recruiting
Sponsor(s): National Institute of Dental and Craniofacial Research (NIDCR) ,
Synopsis: The primary purpose of this clinical trial is to determine whether low-dose doxycycline can reduce alveolar bone density loss in postmenopausal women not on hormone replacement therapy (i.e., estrogen-deficient).
Details: The primary purpose of this trial is to determine whether low-dose doxycycline (LDD) can reduce alveolar bone density loss in postmenopausal osteopenic women not on hormone replacement therapy (i.e., estrogen-deficient). The effects of LDD on alveolar bone height loss, progressive periodontal attachment loss, systemic bone density, and serum and gingival crevicular fluid biochemical markers of bone formation and bone resorption 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 the State University of New York at Stony Brook School of Dental Medicine. A total of 128 osteopenic postmenopausal women between the ages of 45 and 70 at telephone screening will be randomized to LDD or placebo groups and subjects will be followed for two year
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 45 Years/70 Years
Genders: Female
Protocol Entry 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.
Total Enrollment: 128
Location and Contact Information:
Department of Oral Biology and Pathology
Stony Brook, New York, 11794-8702
United States
UNMC College of Dentistry
Lincoln, Nebraska, 68583-0740
United States
Additional Information:
Study ID Numbers: NIDCR-12872;
Study Start Date: June 2002
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066027
Other Osteopenia Studies:
1. Nitroglycerin Ointment for Preventing Bone Loss in Postmenopausal Women
2. Adding Phosphorus to Osteoporosis Drug Treatment
3. Phase 2 Study assessing AMG 162 in the treatment of women with low bone density
4. Bone Loss in Premenopausal Women with Depression
5. Electromagnetic Treatment For Bone Loss After Forearm Fracture
Related Studies:
Other Osteopenia Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
Effects of Low-Dose Doxycycline on Oral Bone Loss
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