Effects of Low-Dose Doxycycline on Oral Bone Loss
Low-Dose Doxycycline Effects on Osteopenic Bone Loss
2 other identifiers
interventional
128
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2002
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 1, 2003
CompletedFirst Posted
Study publicly available on registry
August 5, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedSeptember 6, 2023
September 1, 2023
3.3 years
August 1, 2003
September 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alveolar Bone Density
Alveolar bone density changes assessed by radiographic absorptiometry and computer-assisted densitometric image analysis.
Baseline, one-year and two-year visits
Study Arms (2)
low-dose doxycycline
EXPERIMENTALlow-dose doxycycline (20 mg doxycycline hyclate)
Placebo
PLACEBO COMPARATORPlacebo
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Nebraska Medical Center, College of Dentistry
Lincoln, Nebraska, 68583-0740, United States
Department of Oral Biology and Pathology
Stony Brook, New York, 11794-8702, United States
Related Publications (13)
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.
PMID: 18538066BACKGROUNDSalminen 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/s00011-013-0626-z. Epub 2013 May 7.
PMID: 23649042RESULTPayne 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.
PMID: 23205917RESULTGu 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.
PMID: 23071896RESULTPayne 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 Am Dent Assoc. 2011 Mar;142(3):262-73. doi: 10.14219/jada.archive.2011.0165.
PMID: 21357860RESULTPayne 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.
PMID: 20937388RESULTGolub 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.
PMID: 20348487RESULTReinhardt 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/jop.2009.090374.
PMID: 20151804RESULTGolub 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;79(8):1409-18. doi: 10.1902/jop.2008.070623.
PMID: 18672990RESULTWalker 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.
PMID: 17668979RESULTPayne JB, Stoner JA, Lee HM, Nummikoski PV, Reinhardt RA, Golub LM. Serum bone biomarkers and oral/systemic bone loss in humans. J Dent Res. 2011 Jun;90(6):747-51. doi: 10.1177/0022034511402993. Epub 2011 Mar 21.
PMID: 21422479DERIVEDPayne JB, Stoner JA, Nummikoski PV, Reinhardt RA, Goren AD, Wolff MS, Lee HM, Lynch JC, Valente R, Golub LM. Subantimicrobial dose doxycycline effects on alveolar bone loss in post-menopausal women. J Clin Periodontol. 2007 Sep;34(9):776-87. doi: 10.1111/j.1600-051X.2007.01115.x.
PMID: 17716313DERIVEDReinhardt RA, Stoner JA, Golub LM, Wolff MS, Lee HM, Meinberg TA, Lynch JC, Ryan ME, Sorsa T, Payne JB. Efficacy of sub-antimicrobial dose doxycycline in post-menopausal women: clinical outcomes. J Clin Periodontol. 2007 Sep;34(9):768-75. doi: 10.1111/j.1600-051X.2007.01114.x.
PMID: 17716312DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey B Payne, DDS
UNMC College of Dentistry
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2003
First Posted
August 5, 2003
Study Start
June 1, 2002
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
September 6, 2023
Record last verified: 2023-09