Bisphosphonates Effects On Alveolar Bone Among Osteoporotic Women
NCT ID: NCT02115490
Last Updated: 2015-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
60 participants
OBSERVATIONAL
2014-04-30
2015-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Osteoporotic women, under bisphosphonates therapy or not, will be invited to participate in this study. In addition, osteopenic and normal women regarding bone fragility will be included too, for comparison purposes. Panoramic radiographs will be taken. In addition, women under bisphosphonates for 6 months or more will be scanned by Cone -beam CT as it can give an idea about bone histomorphometry with a low radiation dose.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients
NCT04702204
The Effect of Long-term Use of Bisphosphonates on Femur Morphology
NCT06621069
Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects
NCT00666627
A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
NCT02157948
Dental Care and Initiation of Anti-osteoporotic Therapy
NCT05719818
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In this study, their effects on alveolar bone are going to be evaluated using panoramic radiography and Cone-beam CT, as well as the clinical parameters of periodontal diseases. Cone-beam CT will also offer a way to compare bone histomorphometry of the jaws between groups. Bisphosphonates will be prescribed by physicians of osteoporotic women. The investigators will not interfere drug administration at all. Thus, the investigators can test their indirect effect on jaw bones. Osteoporotic women, who used bisphosphonates for 6 months minimum, will be invited to participate in this investigation. In addition, women with osteoporosis who are not under one of the bisphosphonates will be invited too, as a control. Control group will also include a number of osteopenic and normal women for comparison purposes, as these medications are not indicated for them. Women should be free of bone diseases other than osteoporosis or osteopenia.
On panoramic radiographs, radiographic bone density and mandibular cortical index will be assessed. Aluminum step-wedge will be used with panoramic radiography as it offers more accurate density measurements. In Cone-beam CT, radiographic density, apparent bone histomorphometric analysis and radiographic parameters of the periodontal disease will be assessed. Clinical measurements of periodontal disease will be recorded for two purposes. First, to adjust for the confounding factor (periodontal disease) when evaluating the trabecular bone between groups. Second, to test if using these drugs improve the periodontal status as their benefits are still controversial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Osteoporosis_with_Bisphosphonates
This group of patients are taking Bisphosphonates orally in their treatment
Bisphosphonates
Osteoporosis-without-Bisphosphonates
This group of patients has not taken Bisphosphonates in the course of treatment
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bisphosphonates
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Women with osteoporosis who are not under bisphosphonates yet, or are not indicated for such therapy.
* Women with osteopenia either using or not bisphosphonates.
Exclusion Criteria
45 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Damascus University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Imad Barngkgei, DDS MSc
Role: PRINCIPAL_INVESTIGATOR
PhD student, Department of Oral Medicine, University of Damascus Dental School, Damascus
Iyad Al-Haffar, DDS MSc PhD
Role: STUDY_DIRECTOR
Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School, Damascus
Razan Khattab, DDS MSc PhD
Role: STUDY_DIRECTOR
Professor of Periodontology, Department of Periodontology, University of Damascus Dental School, Damascus, SYRIA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Damascus Dental School
Damascus, Syrian Arab Republic, Syria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy, March 7-29, 2000: highlights of the conference. South Med J. 2001 Jun;94(6):569-73. No abstract available.
Darcey J, Devlin H, Lai D, Walsh T, Southern H, Marjanovic E, Horner K. An observational study to assess the association between osteoporosis and periodontal disease. Br Dent J. 2013 Dec;215(12):617-621. doi: 10.1038/sj.bdj.2013.1191.
Devlin H. Identification of the risk for osteoporosis in dental patients. Dent Clin North Am. 2012 Oct;56(4):847-61. doi: 10.1016/j.cden.2012.07.010. Epub 2012 Aug 13.
Doube M, Klosowski MM, Arganda-Carreras I, Cordelieres FP, Dougherty RP, Jackson JS, Schmid B, Hutchinson JR, Shefelbine SJ. BoneJ: Free and extensible bone image analysis in ImageJ. Bone. 2010 Dec;47(6):1076-9. doi: 10.1016/j.bone.2010.08.023. Epub 2010 Sep 15.
Ho JT, Wu J, Huang HL, Chen MY, Fuh LJ, Hsu JT. Trabecular bone structural parameters evaluated using dental cone-beam computed tomography: cellular synthetic bones. Biomed Eng Online. 2013 Nov 9;12:115. doi: 10.1186/1475-925X-12-115.
Jeffcoat MK, Cizza G, Shih WJ, Genco R, Lombardi A. Efficacy of bisphosphonates for the control of alveolar bone loss in periodontitis. J Int Acad Periodontol. 2007 Jul;9(3):70-6.
Kalsi R, Vandana KL, Prakash S. Effect of local drug delivery in chronic periodontitis patients: A meta-analysis. J Indian Soc Periodontol. 2011 Oct;15(4):304-9. doi: 10.4103/0972-124X.92559.
Karaguzel G, Holick MF. Diagnosis and treatment of osteopenia. Rev Endocr Metab Disord. 2010 Dec;11(4):237-51. doi: 10.1007/s11154-010-9154-0.
Koh KJ, Kim KA. Utility of the computed tomography indices on cone beam computed tomography images in the diagnosis of osteoporosis in women. Imaging Sci Dent. 2011 Sep;41(3):101-6. doi: 10.5624/isd.2011.41.3.101. Epub 2011 Sep 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UDDS-OraMed-01-2014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.