Effects of Low-Dose Doxycycline on Oral Bone Loss

Periodontitis Clinical Trial

Official title:

Low-Dose Doxycycline Effects on Osteopenic Bone Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066027
• Other study ID #: 0511-00-FB
• Secondary ID: R01DE012872
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2002
• Est. completion date: October 1, 2005

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 1, 2005
• Est. primary completion date: October 1, 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, College of Dentistry	Lincoln	Nebraska
United States	Department of Oral Biology and Pathology	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (10)

Golub LM, Lee HM, Stoner JA, Reinhardt RA, Sorsa T, Goren AD, Payne JB. Doxycycline effects on serum bone biomarkers in post-menopausal women. J Dent Res. 2010 Jun;89(6):644-9. doi: 10.1177/0022034510363367. Epub 2010 Mar 26. — View Citation

Golub LM, Lee HM, Stoner JA, Sorsa T, Reinhardt RA, Wolff MS, Ryan ME, Nummikoski PV, Payne JB. Subantimicrobial-dose doxycycline modulates gingival crevicular fluid biomarkers of periodontitis in postmenopausal osteopenic women. J Periodontol. 2008 Aug;7 — View Citation

Gu Y, Walker C, Ryan ME, Payne JB, Golub LM. Non-antibacterial tetracycline formulations: clinical applications in dentistry and medicine. J Oral Microbiol. 2012;4. doi: 10.3402/jom.v4i0.19227. Epub 2012 Oct 12. — View Citation

Payne JB, Golub LM, Stoner JA, Lee HM, Reinhardt RA, Sorsa T, Slepian MJ. The effect of subantimicrobial-dose-doxycycline periodontal therapy on serum biomarkers of systemic inflammation: a randomized, double-masked, placebo-controlled clinical trial. J A — View Citation

Payne JB, Golub LM. Using tetracyclines to treat osteoporotic/osteopenic bone loss: from the basic science laboratory to the clinic. Pharmacol Res. 2011 Feb;63(2):121-9. doi: 10.1016/j.phrs.2010.10.006. Epub 2010 Oct 16. — View Citation

Payne JB, Nummikoski PV, Thompson DM, Golub LM, Stoner JA. The association between clinical and radiographic periodontitis measurements during periodontal maintenance. J Periodontol. 2013 Oct;84(10):1382-90. doi: 10.1902/jop.2012.120484. Epub 2012 Dec 3. — View Citation

Reinhardt RA, Stoner JA, Golub LM, Lee HM, Nummikoski PV, Sorsa T, Payne JB. Association of gingival crevicular fluid biomarkers during periodontal maintenance with subsequent progressive periodontitis. J Periodontol. 2010 Feb;81(2):251-9. doi: 10.1902/jo — View Citation

Salminen A, Pussinen PJ, Payne JB, Stoner JA, Jauhiainen M, Golub LM, Lee HM, Thompson DM, Sorsa T. Subantimicrobial-dose doxycycline treatment increases serum cholesterol efflux capacity from macrophages. Inflamm Res. 2013 Jul;62(7):711-20. doi: 10.1007/ — View Citation

Stoner JA, Payne JB. Interpretation of treatment effects in periodontal research: a note on the number needed to treat. J Can Dent Assoc. 2008 Jun;74(5):435-7. No abstract available. — View Citation

Walker C, Puumala S, Golub LM, Stoner JA, Reinhardt RA, Lee HM, Payne JB. Subantimicrobial dose doxycycline effects on osteopenic bone loss: microbiologic results. J Periodontol. 2007 Aug;78(8):1590-601. doi: 10.1902/jop.2007.070015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar Bone Density	Alveolar bone density changes assessed by radiographic absorptiometry and computer-assisted densitometric image analysis.	Baseline, one-year and two-year visits