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
  Purpose

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).


Condition Intervention Phase
Periodontitis
Drug: 20 mg doxycycline hyclate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low-Dose Doxycycline Effects on Osteopenic Bone Loss

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • alveolar bone density [ Time Frame: Baseline, one-year and two-year visits ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: June 2002
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: low-dose doxycycline
low-dose doxycycline (20 mg doxycycline hyclate)
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.
Placebo Comparator: Placebo
Placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066027

Locations
United States, Nebraska
UNMC College of Dentistry
Lincoln, Nebraska, United States, 68583-0740
United States, New York
Department of Oral Biology and Pathology
Stony Brook, New York, United States, 11794-8702
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Jeffrey B Payne, Dr UNMC College of Dentistry
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey Payne, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT00066027     History of Changes
Other Study ID Numbers: 511-00-FB, R01DE012872
Study First Received: August 1, 2003
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Nebraska:
periodontitis, metabolic bone diseases, doxycycline

Additional relevant MeSH terms:
Periodontitis
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014