OsteoporosisNCT02115490
Bisphosphonates Effects On Alveolar Bone Among Osteoporotic Women
An observational study of Osteoporosis, run by Damascus University at 1 site in Syria.
Trial summary
Osteoporosis is a public health problem. It is a skeletal disease being treated by Bisphosphonates as the first choice medication. The effects of these drugs were investigated for periodontal disease treatment both locally and systemically. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Bisphosphonates
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteSyria
- Study dates
- Apr 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who were referred to perform Dual Energy X-Ray Absorptiometry (DXA) examination will be invited to participate in this study if they were diagnosed with osteoporosis. They may be under bisphosphonates or not. They will be met in Alassd and Almowsat University-Hospitals where DXA is available. If they meet inclusion criteria, mentioned below, they will be invited.
Who may be able to join
- Women with osteoporosis who already use bisphosphonates.
- Women with osteoporosis who are not under bisphosphonates yet, or are not indicated for such therapy.
- Women with osteopenia either using or not bisphosphonates.
Who cannot join
- Women with bone diseases other than osteoporosis or osteopenia
Trial locations and contacts
1 site in 1 country.
Syria1 site
University of Damascus Dental School
Damascus, Syrian Arab Republic, DM20AM18
About this study
Official title: The Effect of Orally Administered Bisphosphonates in the Treatment of Osteoporosis on the Alveolar Bone Using Panoramic and Cone-Beam CT Imaging: A Case-control Study
Osteoporosis is a public health problem. It is a skeletal disease being treated by Bisphosphonates as the first choice medication. The effects of these drugs were investigated for periodontal disease treatment both locally and systemically. However, it is very important to know their indirect effects on alveolar bone (i.e. their effects when used for treating osteoporosis). So, in this study, alternations that involve the alveolar bone when osteoporotic women use bisphosphonates will be studied radiologically using cone-beam CT and digital panoramic radiography. The goal is to provide dentists with information about changes in the characterization of the alveolar bone among these women. This is important for both periodontology and implantology. Maxillary and mandibular bone structural characterization among osteoporotic women had not been studied before. Furthermore, in an opposite direction, dental radiographs may aid in detecting osteoporosis.
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.
Read the detailed description
Osteoporosis is a skeletal disease characterized by a low bone mass, deterioration of the bone structure and an increased risk of bone fracture. Although jaws are not at risk of fracture, they revealed changes due to the disease. Bisphosphonates are the most common medical therapy for osteoporosis as they improve bone structure and reduce its absorption. From a periodontal point of view, it was suggested as an adjunctive therapy for periodontal bone loss. Controversy exists regarding their effects, however. In addition, their effects on the periodontal status and jaw bones are unknown when these drugs are prescribed for treating osteoporosis, i.e. not for periodontal purposes. It is also unknown whether their effects on alveolar bone, if any, can be detected by simple radiographs (such as panoramic radiographs) or required advanced techniques (e.g. Cone-beam CT).
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
- Osteoporosis
- Being tested
- Bisphosphonates
- Keywords
- Alveolar bone, Bisphosphonates, Cone-beam CT, Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisphosphonatesDrug
| Study group | Role | What they receive |
|---|---|---|
| Osteoporosis_with_Bisphosphonates | This group of patients are taking Bisphosphonates orally in their treatment Receives: Drug: Bisphosphonates | |
| Osteoporosis-without-Bisphosphonates | This group of patients has not taken Bisphosphonates in the course of treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D-based Alveolar bone radiographic density
Bone radiographic density will be assessed using special software of cone beam CT
Measured: One-time assessment; once the woman is scanned by CBCT
Secondary outcomes (3)
Alveolar bone histomorphometry
Bone histomorphometry will be assessed using special software used primarily with Micro-CT scans
Measured: One-time assessment; once the patient is scanned by CBCT
2D-based Alveolar bone radiographic density
This will be assessed using conventional panoramic radiographs
Measured: One-time assessment; once the patient is radiographed
Periodontal Disease Index (PDI)
Measured: One-time assessment in the day of performing the X-ray imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imad Barngkgei, DDS MSc, Principal investigator, PhD student, Department of Oral Medicine, University of Damascus Dental School, DamascusIyad Al-Haffar, DDS MSc PhD, Study director, Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School, DamascusRazan Khattab, DDS MSc PhD, Study director, Professor of Periodontology, Department of Periodontology, University of Damascus Dental School, Damascus, SYRIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115490
- Sponsor's protocol ID
- UDDS-OraMed-01-2014
- Status last verified
- Sep 2015
- First submitted
- 11 Apr 2014
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11440324Darcey 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.
PubMed 24357765Devlin 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.
PubMed 23017555Doube 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.
PubMed 20817052Ho 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.
PubMed 24207062Jeffcoat 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.
PubMed 17715838Kalsi 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.
PubMed 22368351Karaguzel 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.
PubMed 21234807Koh 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.
PubMed 22010066
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Orally Administered Bisphosphonates in the Treatment of Osteoporosis on the Alveolar Bone Using Panoramic and Cone-Beam CT Imaging: A Case-control Study
- ClinicalTrials.gov ID
- NCT02115490
- Acronym / sponsor ID
- UDDS-OraMed-01-2014
- Conditions
- Osteoporosis
- Keywords
- Alveolar bone, Bisphosphonates, Cone-beam CT, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoporosis is a public health problem. It is a skeletal disease being treated by Bisphosphonates as the first choice medication. The effects of these drugs were investigated for periodontal disease treatment both locally and systemically. However, it is very important to know their indirect effects on alveolar bone (i.e. their effects when used for treating osteoporosis). So, in this study, alternations that involve the alveolar bone when osteoporotic women use bisphosphonates will be studied radiologically using cone-beam CT and digital panoramic radiography. The goal is to provide dentists with information about changes in the characterization of the alveolar bone among these women. This is important for both periodontology and implantology. Maxillary and mandibular bone structural characterization among osteoporotic women had not been studied before. Furthermore, in an opposite direction, dental radiographs may aid in detecting osteoporosis.
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.
Detailed description
Osteoporosis is a skeletal disease characterized by a low bone mass, deterioration of the bone structure and an increased risk of bone fracture. Although jaws are not at risk of fracture, they revealed changes due to the disease. Bisphosphonates are the most common medical therapy for osteoporosis as they improve bone structure and reduce its absorption. From a periodontal point of view, it was suggested as an adjunctive therapy for periodontal bone loss. Controversy exists regarding their effects, however. In addition, their effects on the periodontal status and jaw bones are unknown when these drugs are prescribed for treating osteoporosis, i.e. not for periodontal purposes. It is also unknown whether their effects on alveolar bone, if any, can be detected by simple radiographs (such as panoramic radiographs) or required advanced techniques (e.g. Cone-beam CT).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoporosis_with_Bisphosphonates | – | Drug: BisphosphonatesThis group of patients are taking Bisphosphonates orally in their treatment |
| Osteoporosis-without-Bisphosphonates | – | –This group of patients has not taken Bisphosphonates in the course of treatment |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who were referred to perform Dual Energy X-Ray Absorptiometry (DXA) examination will be invited to participate in this study if they were diagnosed with osteoporosis. They may be under bisphosphonates or not. They will be met in Alassd and Almowsat University-Hospitals where DXA is available. If they meet inclusion criteria, mentioned below, they will be invited.
Key inclusion criteria (3 listed)
- Women with osteoporosis who already use bisphosphonates.
- Women with osteoporosis who are not under bisphosphonates yet, or are not indicated for such therapy.
- Women with osteopenia either using or not bisphosphonates.
Key exclusion criteria (1 listed)
- Women with bone diseases other than osteoporosis or osteopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bisphosphonates | Drug | Osteoporosis_with_Bisphosphonates |
Primary outcome
3D-based Alveolar bone radiographic density
Time frame: One-time assessment; once the woman is scanned by CBCT
Bone radiographic density will be assessed using special software of cone beam CT
3 secondary outcomes
Alveolar bone histomorphometry
Time frame: One-time assessment; once the patient is scanned by CBCT
2D-based Alveolar bone radiographic density
Time frame: One-time assessment; once the patient is radiographed
Periodontal Disease Index (PDI)
Time frame: One-time assessment in the day of performing the X-ray imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2015.
- Background: PubMed 11440324NIH 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.
- Background: PubMed 24357765Darcey 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.
- Background: PubMed 23017555Devlin 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.
- Background: PubMed 20817052Doube 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.
- Background: PubMed 24207062Ho 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.
- Background: PubMed 17715838Jeffcoat 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.
- Background: PubMed 22368351Kalsi 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.
- Background: PubMed 21234807Karaguzel 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.
- Background: PubMed 22010066Koh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Imad Barngkgei, DDS MSc principal investigator
PhD student, Department of Oral Medicine, University of Damascus Dental School, Damascus
Iyad Al-Haffar, DDS MSc PhD study director
Associate Professor of Oral Medicine, Department of Oral Medicine, University of Damascus Dental School, Damascus
Razan Khattab, DDS MSc PhD study director
Professor of Periodontology, Department of Periodontology, University of Damascus Dental School, Damascus, SYRIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D-based Alveolar bone radiographic density (time frame: One-time assessment; once the woman is scanned by CBCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02115490, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2015.