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Effects of Low-Dose Doxycycline on Oral Bone Loss
This study has been completed.
Study NCT00066027   Information provided by National Institute of Dental and Craniofacial Research (NIDCR)
First Received: August 1, 2003   Last Updated: April 9, 2008   History of Changes

August 1, 2003
April 9, 2008
June 2002
October 2005   (final data collection date for primary outcome measure)
alveolar bone density [ Time Frame: Baseline, one-year and two-year visits ] [ Designated as safety issue: No ]
alveolar bone density
Complete list of historical versions of study NCT00066027 on ClinicalTrials.gov Archive Site
 
 
 
Effects of Low-Dose Doxycycline on Oral Bone Loss
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).

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.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Periodontitis
Drug: 20 mg doxycycline hyclate
Experimental: The experimental group received low-dose doxycycline; the placebo group received a placebo control.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
128
October 2005
October 2005   (final data collection date for primary outcome measure)

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.
Female
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066027
Dr. Jeffrey Payne, Principal Investigator, University of Nebraska Medical Center (UNMC) College of Dentistry
NIDCR-12872
National Institute of Dental and Craniofacial Research (NIDCR)
 
Principal Investigator: Jeffrey B Payne, Dr UNMC College of Dentistry
National Institute of Dental and Craniofacial Research (NIDCR)
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP