Effects of Low-Dose Doxycycline on Oral Bone Loss

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Payne, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00066027
First received: August 1, 2003
Last updated: November 11, 2013
Last verified: November 2013

August 1, 2003
November 11, 2013
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 ]
Not Provided
Complete list of historical versions of study NCT00066027 on ClinicalTrials.gov Archive Site
Not Provided
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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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Periodontitis
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.
  • Experimental: low-dose doxycycline
    low-dose doxycycline (20 mg doxycycline hyclate)
    Intervention: Drug: 20 mg doxycycline hyclate
  • Placebo Comparator: Placebo
    Placebo

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

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.
Female
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066027
511-00-FB, R01DE012872
Yes
Jeffrey Payne, University of Nebraska
University of Nebraska
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Jeffrey B Payne, Dr UNMC College of Dentistry
University of Nebraska
November 2013

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