OsteoporosisNCT02303340
Diagnosis of Decreased Bone Density by Dental Cone Beam Computed Tomography
An observational study of Osteoporosis, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to elucidate the role of Dental Cone Beam Computed Tomography (CBCT) in assessment of bone density. The study population contains men and women above the age of 60 years, eligible for Bone Density Testing in accordance with their health insurance, who underwent a Dental CBCT recommended by… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Dual Energy X-ray Absorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2015to Dec 2018
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men and women above the age of 60 years, eligible for Bone Density Testing in accordance with their health insurance, who underwent a Dental CBCT recommended by their Dental Practitioner.
Who may be able to join
- Men and women above the age of 60 years.
- Underwent Dental Cone Beam Tomography for dental reasons, up to three months before screening.
- Patients underwent bone density examination at Soroka Medical Center only, during the last year prior commencing the research will be eligible for participation without the need for an additional bone density scanning.
Who cannot join
- Patients with current or past treatment of any osteoporotic medication: Alendronate (Alendronate teva, Fosamax, Maxibone , Fosalan, Fosavance), Residronate (Actonel. Ribone), Zoledronic acid (Aclasta, Zomera), Denosumab (Prolia), Teriperatide (Forteo),Raloxifen ( Evista), Stronsium Ranelate (Protelos).
- Patients taking Corticosteroid Therapy.
- Patients with history of Head and Neck Neoplasia or Head and Neck Irradiation or Bone Metastasis.
- Patients with hard tissue pathology of the jaws.
- Patients after laminectomy and or fixation of lumbar vertebrae or after bilateral hip replacement.
- Diagnosis of primary hyperparathyroidism.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Soroka University Medical Center
Beersheba
Rita Troitsa, BA, 972-5-8020985, ritatr@clalit.org.il
About this study
The purpose of this study is to elucidate the role of Dental Cone Beam Computed Tomography (CBCT) in assessment of bone density. The study population contains men and women above the age of 60 years, eligible for Bone Density Testing in accordance with their health insurance, who underwent a Dental CBCT recommended by their Dental Practitioner. Any patient (eligible for bone density screening by age criteria) undergoing CBCT of either one of the jaws (or both) due to dental reasons, will be sent to a bone mineral density DEXA Scan, and for blood testing for PTH, Phosphor, Calcium ,Vitamin D and Creatinine levels.
Density measurements will be done in specific sites on the CBCT's of the jaws. These measurements will be correlated with the blood tests and DEXA scan results.
Read the detailed description
The purpose of this study is to elucidate the role of Dental Cone Beam Computed Tomography in assessment of bone density.
The study population contains men and women above the age of 60 years, eligible for Bone Density Testing in accordance with their health insurance, who underwent a Dental CBCT recommended by their Dental Practitioner. Any patient (eligible for bone density screening by age criteria) undergoing CBCT of either one of the jaws (or both) due to dental reasons, will be sent to dual energy x-ray absorptiometry (DEXA) Scan, and for blood testing for parathormone (PTH), Phosphor, Calcium ,Vitamin D and Creatinine levels.
The investigators estimate thousands of Dental Cone Beam Computed Tomographies are being ordered every year, due to dental needs in Israel. In this preliminary prospective pilot study the investigators will evaluate 50 subjects who underwent both Dental CBCT and DEXA scan as a preliminary testing.
Density measurements will be done in specific sites on the CBCT's of the jaws. These measurements will be correlated with the blood tests and DEXA scan results.
The outcomes of this study are:
- Bone density measurement on Dental CBCT can be used for diagnosis of low bone mass conditions.
- There is an association between bone density DEXA results, blood tests for Calcium, Phosphor, PTH and Vitamin D and Bone density measurements on Dental CBCTs.
- Conditions
- Osteoporosis
- Being tested
- Dual Energy X-ray Absorptiometry
- Keywords
- Cone Beam Computed Tomography, Para Thyroid Hormone, Dual Energy X-ray Absorptiometry, Digital Imaging and Communication in Medicine
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Energy X-ray AbsorptiometryRadiation
Also called DEXA
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Any patient who enrolled and signed informed consent will be sent to bone mineral density DEXA Scan, and for blood testing for PTH, Phosphor, Calcium ,Vitamin D and Creatinine levels. Density measurements will be done in specific sites on the CBCT's of the jaws. Receives: Radiation: Dual Energy X-ray Absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that have Osteoporosis that was shown on the dental CT and the DEXA exams
Measured: 12 months
Secondary outcomes (1)
Association between bone density DEXA results, blood tests for Calcium, Phosphor, PTH and Vitamin D and Bone density measurements on Dental CBCTs
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben-Zion Joshua, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303340
- Sponsor's protocol ID
- sor 0130-13-ctil
- Status last verified
- Mar 2016
- First submitted
- 20 Nov 2014
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindsay R, Cosman F. Chapter 354. Osteoporosis. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson JL, Loscalzo J, eds. Harrison's Principles of Internal Medicine. 18th ed. New York: McGraw-Hill; 2012.
Scarfe WC, Farman AG, Sukovic P. Clinical applications of cone-beam computed tomography in dental practice. J Can Dent Assoc. 2006 Feb;72(1):75-80.
PubMed 16480609Valiyaparambil JV, Yamany I, Ortiz D, Shafer DM, Pendrys D, Freilich M, Mallya SM. Bone quality evaluation: comparison of cone beam computed tomography and subjective surgical assessment. Int J Oral Maxillofac Implants. 2012 Sep-Oct;27(5):1271-7.
PubMed 23057044Padbury AD Jr, Tozum TF, Taba M Jr, Ealba EL, West BT, Burney RE, Gauger PG, Giannobile WV, McCauley LK. The impact of primary hyperparathyroidism on the oral cavity. J Clin Endocrinol Metab. 2006 Sep;91(9):3439-45. doi: 10.1210/jc.2005-2282. Epub 2006 Jul 5.
PubMed 16822829Hastar E, Yilmaz HH, Orhan H. Evaluation of mental index, mandibular cortical index and panoramic mandibular index on dental panoramic radiographs in the elderly. Eur J Dent. 2011 Jan;5(1):60-7.
PubMed 21228957Neves FS, Oliveira LS, Torres MG, Toralles MB, da Silva MC, Campos MI, Campos PS, Crusoe-Rebello I. Evaluation of panoramic radiomorphometric indices related to low bone density in sickle cell disease. Osteoporos Int. 2012 Jul;23(7):2037-42. doi: 10.1007/s00198-011-1810-z. Epub 2011 Oct 18.
PubMed 22006042Taguchi A. Triage screening for osteoporosis in dental clinics using panoramic radiographs. Oral Dis. 2010 May;16(4):316-27. doi: 10.1111/j.1601-0825.2009.01615.x. Epub 2009 Aug 7.
PubMed 19671082Halling A, Persson GR, Berglund J, Johansson O, Renvert S. Comparison between the Klemetti index and heel DXA BMD measurements in the diagnosis of reduced skeletal bone mineral density in the elderly. Osteoporos Int. 2005 Aug;16(8):999-1003. doi: 10.1007/s00198-004-1796-x. Epub 2004 Dec 17.
PubMed 15605191Mah P, Reeves TE, McDavid WD. Deriving Hounsfield units using grey levels in cone beam computed tomography. Dentomaxillofac Radiol. 2010 Sep;39(6):323-35. doi: 10.1259/dmfr/19603304.
PubMed 20729181Romme EA, Murchison JT, Phang KF, Jansen FH, Rutten EP, Wouters EF, Smeenk FW, Van Beek EJ, Macnee W. Bone attenuation on routine chest CT correlates with bone mineral density on DXA in patients with COPD. J Bone Miner Res. 2012 Nov;27(11):2338-43. doi: 10.1002/jbmr.1678.
PubMed 22692725
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Decreased Bone Density by Dental Cone Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT02303340
- Acronym / sponsor ID
- sor 0130-13-ctil
- Conditions
- Osteoporosis
- Keywords
- Cone Beam Computed Tomography, Para Thyroid Hormone, Dual Energy X-ray Absorptiometry, Digital Imaging and Communication in Medicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Nov 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.
The purpose of this study is to elucidate the role of Dental Cone Beam Computed Tomography (CBCT) in assessment of bone density. The study population contains men and women above the age of 60 years, eligible for Bone Density Testing in accordance with their health insurance, who underwent a Dental CBCT recommended by their Dental Practitioner. Any patient (eligible for bone density screening by age criteria) undergoing CBCT of either one of the jaws (or both) due to dental reasons, will be sent to a bone mineral density DEXA Scan, and for blood testing for PTH, Phosphor, Calcium ,Vitamin D and Creatinine levels.
Density measurements will be done in specific sites on the CBCT's of the jaws. These measurements will be correlated with the blood tests and DEXA scan results.
Detailed description
The purpose of this study is to elucidate the role of Dental Cone Beam Computed Tomography in assessment of bone density.
The study population contains men and women above the age of 60 years, eligible for Bone Density Testing in accordance with their health insurance, who underwent a Dental CBCT recommended by their Dental Practitioner. Any patient (eligible for bone density screening by age criteria) undergoing CBCT of either one of the jaws (or both) due to dental reasons, will be sent to dual energy x-ray absorptiometry (DEXA) Scan, and for blood testing for parathormone (PTH), Phosphor, Calcium ,Vitamin D and Creatinine levels.
The investigators estimate thousands of Dental Cone Beam Computed Tomographies are being ordered every year, due to dental needs in Israel. In this preliminary prospective pilot study the investigators will evaluate 50 subjects who underwent both Dental CBCT and DEXA scan as a preliminary testing.
Density measurements will be done in specific sites on the CBCT's of the jaws. These measurements will be correlated with the blood tests and DEXA scan results.
The outcomes of this study are:
- Bone density measurement on Dental CBCT can be used for diagnosis of low bone mass conditions.
- There is an association between bone density DEXA results, blood tests for Calcium, Phosphor, PTH and Vitamin D and Bone density measurements on Dental CBCTs.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Radiation: Dual Energy X-ray AbsorptiometryAny patient who enrolled and signed informed consent will be sent to bone mineral density DEXA Scan, and for blood testing for PTH, Phosphor, Calcium ,Vitamin D and Creatinine levels. Density measurements will be done in specific sites on the CBCT's of the jaws. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women above the age of 60 years, eligible for Bone Density Testing in accordance with their health insurance, who underwent a Dental CBCT recommended by their Dental Practitioner.
Key inclusion criteria (3 listed)
- Men and women above the age of 60 years.
- Underwent Dental Cone Beam Tomography for dental reasons, up to three months before screening.
- Patients underwent bone density examination at Soroka Medical Center only, during the last year prior commencing the research will be eligible for participation without the need for an additional bone density scanning.
Key exclusion criteria (6 listed)
- Patients with current or past treatment of any osteoporotic medication: Alendronate (Alendronate teva, Fosamax, Maxibone , Fosalan, Fosavance), Residronate (Actonel. Ribone), Zoledronic acid (Aclasta, Zomera), Denosumab (Prolia), Teriperatide (Forteo),Raloxifen ( Evista), Stronsium Ranelate (Protelos).
- Patients taking Corticosteroid Therapy.
- Patients with history of Head and Neck Neoplasia or Head and Neck Irradiation or Bone Metastasis.
- Patients with hard tissue pathology of the jaws.
- Patients after laminectomy and or fixation of lumbar vertebrae or after bilateral hip replacement.
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 |
|---|---|---|
| Dual Energy X-ray AbsorptiometryAlso: DEXA | Radiation | Study Group |
Primary outcome
Number of participants that have Osteoporosis that was shown on the dental CT and the DEXA exams
Time frame: 12 months
1 secondary outcome
Association between bone density DEXA results, blood tests for Calcium, Phosphor, PTH and Vitamin D and Bone density measurements on Dental CBCTs
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- BackgroundLindsay R, Cosman F. Chapter 354. Osteoporosis. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson JL, Loscalzo J, eds. Harrison's Principles of Internal Medicine. 18th ed. New York: McGraw-Hill; 2012.
- Background: PubMed 16480609Scarfe WC, Farman AG, Sukovic P. Clinical applications of cone-beam computed tomography in dental practice. J Can Dent Assoc. 2006 Feb;72(1):75-80.
- Background: PubMed 23057044Valiyaparambil JV, Yamany I, Ortiz D, Shafer DM, Pendrys D, Freilich M, Mallya SM. Bone quality evaluation: comparison of cone beam computed tomography and subjective surgical assessment. Int J Oral Maxillofac Implants. 2012 Sep-Oct;27(5):1271-7.
- Background: PubMed 16822829Padbury AD Jr, Tozum TF, Taba M Jr, Ealba EL, West BT, Burney RE, Gauger PG, Giannobile WV, McCauley LK. The impact of primary hyperparathyroidism on the oral cavity. J Clin Endocrinol Metab. 2006 Sep;91(9):3439-45. doi: 10.1210/jc.2005-2282. Epub 2006 Jul 5.
- Background: PubMed 21228957Hastar E, Yilmaz HH, Orhan H. Evaluation of mental index, mandibular cortical index and panoramic mandibular index on dental panoramic radiographs in the elderly. Eur J Dent. 2011 Jan;5(1):60-7.
- Background: PubMed 22006042Neves FS, Oliveira LS, Torres MG, Toralles MB, da Silva MC, Campos MI, Campos PS, Crusoe-Rebello I. Evaluation of panoramic radiomorphometric indices related to low bone density in sickle cell disease. Osteoporos Int. 2012 Jul;23(7):2037-42. doi: 10.1007/s00198-011-1810-z. Epub 2011 Oct 18.
- Background: PubMed 19671082Taguchi A. Triage screening for osteoporosis in dental clinics using panoramic radiographs. Oral Dis. 2010 May;16(4):316-27. doi: 10.1111/j.1601-0825.2009.01615.x. Epub 2009 Aug 7.
- Background: PubMed 15605191Halling A, Persson GR, Berglund J, Johansson O, Renvert S. Comparison between the Klemetti index and heel DXA BMD measurements in the diagnosis of reduced skeletal bone mineral density in the elderly. Osteoporos Int. 2005 Aug;16(8):999-1003. doi: 10.1007/s00198-004-1796-x. Epub 2004 Dec 17.
- Background: PubMed 20729181Mah P, Reeves TE, McDavid WD. Deriving Hounsfield units using grey levels in cone beam computed tomography. Dentomaxillofac Radiol. 2010 Sep;39(6):323-35. doi: 10.1259/dmfr/19603304.
- Background: PubMed 22692725Romme EA, Murchison JT, Phang KF, Jansen FH, Rutten EP, Wouters EF, Smeenk FW, Van Beek EJ, Macnee W. Bone attenuation on routine chest CT correlates with bone mineral density on DXA in patients with COPD. J Bone Miner Res. 2012 Nov;27(11):2338-43. doi: 10.1002/jbmr.1678.
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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.
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 Soroka University Medical Center at 1 site in Israel.
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 6 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: status not confirmed, as of the sponsor's last update on 16 Mar 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshuah Ben Zion, MD (972-52-4226400, BenzionJ@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that have Osteoporosis that was shown on the dental CT and the DEXA exams (time frame: 12 months). 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 NCT02303340, which also lists 10 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 16 Mar 2016.