Official Title: “Low-Dose Doxycycline Effects on Osteopenic Bone Loss”

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).

Study Type: Interventional

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

Study Primary Completion Date: October 2005

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.

Intervention(s) in this Clinical Trial

• Drug: 20 mg doxycycline hyclate
  • Subjects in the LDD group took 20 mg doxycycline hyclate tablets twice daily for two years; subjects in the placebo group took a placebo look-alike twice daily for two years.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A vs. B
  • The experimental group received low-dose doxycycline; the placebo group received a placebo control.

Primary Measures

• alveolar bone density
  • Time Frame: Baseline, one-year and two-year visits
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

Overall Clinical Trial Officials and Contacts

Jeffrey B Payne, Dr Principal Investigator UNMC College of Dentistry  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00066027

Study ID Number: NIDCR-12872

ClinicalTrials.gov Identifier: NCT00066027

Health Authority: United States: Food and Drug Administration