| 1537 Doxycycline Effects on Osteopenic Bone Loss: Trial Design and Recruitment | ||
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J.B. PAYNE1, J.A. STONER2, R.A. REINHARDT1, M.S. WOLFF3, J.C. LYNCH2, J.A. LAYTON1, H.-M. LEE3, A. LAHNERS2, T.A. MEINBERG1, A.D. GOREN3, M.E. RYAN3, and L.M. GOLUB3, 1University of Nebraska Medical Center College of Dentistry, Lincoln, USA, 2University of Nebraska Medical Center College of Medicine, Omaha, USA, 3State University of New York - SUNY - Stony Brook, USA Our group has shown that postmenopausal (PM) women with osteoporosis or osteopenia are at greater risk of progressive alveolar bone loss associated with periodontitis. We are conducting a two-year, randomized, double-blind, placebo-controlled, two-center clinical trial to determine whether subantimicrobial-dose doxycycline (SDD) can improve clinical and radiographic periodontal disease parameters (radiographic alveolar bone density [primary endpoint]) in PM, osteopenic, estrogen-deficient women. Secondary objectives include lumbar spine and femoral neck bone mineral density (BMD). Objectives: The purpose of this abstract is to present the trial design, recruitment and baseline subject characteristics. Methods: Women were referred from periodontists and general dentists to the study centers (NE and NY) based on age, moderate/severe periodontitis history and being on periodontal maintenance. Subjects who passed telephone screening were invited for clinical screening (medical and dental history review, probing depth recording and systemic BMD determination). Results: Recruitment took 17 months. 675 subjects were telephone screened; 308 subjects were eligible for and attended clinical screening visit. 65.7% of 251 subjects who had systemic BMD scans had osteoporosis or osteopenia. 136 subjects (44% of subjects clinically screened) qualified and 128 eligible subjects were randomized between SDD and placebo groups. Most common reasons for telephone screening ineligibility included subjects who had taken: hormone replacement therapy during previous six months (27%); NSAIDs daily (19%); and any other medications to strengthen bones (14%; e.g., bisphosphonates). Specific reasons for ineligibility at clinical screening visit included: normal BMD (50%); did not meet dental criteria (22%; e.g., < 2 posterior teeth with probing depths ³ 5 mm); and osteoporosis (17%). Randomized subjects were, on average, 9.24 years PM (std. dev. 6.79); 51% of subjects were current or former smokers. Conclusion: This abstract describes objectives of this SDD clinical trial, includes primary reasons for screening failure, and baseline study population characteristics. Supported by NIH Grant 5RO1DE012872-04. | ||
| Seq #189 - Host Modulatory Agents and Systemic Influences of Periodontal Therapy 10:45 AM-12:45 PM, Friday, 11 March 2005 Baltimore Convention Center 327 | ||
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