OsteoporosisNCT04365504
Efficacy of Cone Beam Computed Tomography in Diagnosing Osteoporosis
An observational study of Osteoporosis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
SUMMARY TITLE: "Efficacy of Cone Beam Computed Tomography derived radiomorphometric indices in screening of postmenopausal females for osteoporosis." RATIONALE: Osteoporosis is a disease of altered bone architecture affecting primarily elderly and middle-aged women and men, particularly post-menopausal women. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Dual energy X ray absorbtiometry
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 24 Feb 2020to Mar 2021
- How long will I take part?
- 2 Weeks
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Post-menopausal female patients visiting the Department of Oral medicine and Radiology for CBCT for any dental condition and fulfilling the inclusion criteria will be sent for a DXA scan to measure their bone mineral density. Based on their T scores, 3 groups shall be formed - Osteoporotic, Osteopenic and normal females consisting of a minimum of 16 patients in each group.
Who may be able to join
- Post-menopausal females with atleast 5 years since menopause.
- Patients undergoing CBCT and DXA within a span of 2 weeks.
Who cannot join
- Patients in which pathology is detected at the site of measurements, hindering the calculation of indices.
- Patients undergoing hormone replacement therapy.
- Patients with history of diseases affecting bone density- diabetes, thyroid disease, osteoarthritis etc.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
HARSHA POPLI, 08826338134
About this study
Official title: Efficacy of Cone Beam Computed Tomography Derived Radiomorphometric Indices in Screening of Post-Menopausal Females for Osteoporosis.
SUMMARY TITLE: "Efficacy of Cone Beam Computed Tomography derived radiomorphometric indices in screening of postmenopausal females for osteoporosis." RATIONALE: Osteoporosis is a disease of altered bone architecture affecting primarily elderly and middle-aged women and men, particularly post-menopausal women. It is responsible for a high number of fractures and poses a high financial burden in both developed and developing countries. In India, we are in a situation where an important, high- burden disease-osteoporosis is being neglected due to lack of facilities of detection, and unawareness about the other tools of assessing bone mineral density and fracture risk.
Few researchers have explored the use of radiomorphometric indices of Cone Beam Computed Tomography (CBCT) and have concluded that these can be used to differentiate between osteoporotic and non-osteoporotic patients. Increasing use of CBCT for various dental conditions, especially implant planning in older age group of patients, which is prone to osteoporosis, calls for the need for further exploration in this regard. The studies available in the literature are heterogenous in nature and reproducibility of the indices used has not been measured. Also, the sample size in each study was limited alongwith presence of selection bias. Thus, the present study will aim at assessing the efficacy of these indices in CBCT in an Indian population, the studies of which are sparse in literature, which shall aid in timely detection and therefore timely intervention to increase the quality of life and reduce morbidity and mortality occurring as a consequence of this disease.
Read more
RESEARCH QUESTION:
P: Population (Postmenopausal females with Osteoporosis i.e. DXA values below -2.5) I: Intervention (none) C: Control (Non-osteoporotic post-menopausal females) O: Outcome (CTCI, CTMI, CTI(S)and CTI(I) scores) T: Time Frame (1 year) S: Study Design (Cross sectional observational study) Setting in Haryana, India
Are radiomorphometric indices of CBCT useful for detecting the presence of postmenopausal osteoporosis?
Read the detailed description
Osteoporosis is a major health problem worldwide characterized by reduced bone mass and disrupted bone architecture that leads to increased susceptibility to fractures. It has become one of the leading causes of morbidity and mortality in older males and females, occurring more commonly in post-menopausal women.1 The prevalence of osteoporosis varies from 16% to 30% in Caucasian women with 39.7% women risked at sustaining a fracture once in a lifetime.1In a study conducted upon middle aged Indian women, a high prevalence of osteopenia (52%) and osteoporosis (29%) was found, with nutritional deficiency being the causative factor. 2 With such high prevalence rates, the need for timely detection cannot be overemphasized. The disease being largely asymptomatic, comes under the radar of the clinician only when a fracture occurs. The diagnosis is largely centered around measurement of bone mineral density by use of Single and dual X-ray absorptiometry (DXA), Ultrasonic measurement of bone, Computed tomography and Radiography with DXA being the gold standard and also the most commonly used technique.3 Dental radiographs are usually advised for a variety of dental diseases and conditions. This provides an opportunity to use dental radiographs as a screening tool for predicting osteoporosis. The role of pantomographs as a screening tool is well established.8,9 Cone beam computed tomography (CBCT), since its advent in 1999, has been specialised for dental use with its various advantages over conventional CT such as lower exposure dose, higher spatial resolution and space saving. Nowadays, CBCT is the modality of choice for patients requiring implant planning.it provides high resolution images in all three planes thereby allowing accurate quantitative measurements of hard structure. Over the recent years, many clinicians have attempted to establish CBCT as a modality to evaluate bone mineral content(BMC) and have concluded that lumbar vertebrae and femoral neck osteoporosis can be predicted accurately from the radiodensity values of the body of the mandible and it is possible to evaluate BMC from the voxel values of CBCT for dental implant treatment5,6.
However, there is still a controversy regarding use of CBCT for determination of bone quality. CBCT gray values give an approximate density and therefore cannot be expressed as HU as in conventional CT.
Few researchers have explored the use of radio morphometric indices such as computed tomography mandibular index superior (CTI(S)), computed tomography mandibular index inferior (CTI(I)), computed tomography cortical index (CTCI) and the computed tomography mental index (CTMI: inferior cortical width) and have been instrumental in establishing the fact that these indices can be used to differentiate between osteoporotic and non-osteoporotic patients7. Very few studies have been done using CBCT and no such study is available in the literature on an Indian population. Thus, this study will aim at determining the utility of these CBCT indices in detection of osteoporosis (confirmed through DXA scan) to aid in timely detection and therefore timely intervention to increase the quality of life and reduce morbidity and mortality occurring as a consequence of this disease.
- Conditions
- Osteoporosis
- Being tested
- Dual energy X ray absorbtiometry
- Keywords
- Osteoporosis, Post menopausal females, Cone beam computed tomography
- 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 absorbtiometryDiagnostic test
The primary clinical application of dual-energy x-ray absorptiometry (DXA or DEXA) is the measurement of bone mineral content (BMC, g) and bone mineral density (BMD, g/cm2) of the lumbar spine and proximal femur to assess risk for osteoporosis.
| Study group | Role | What they receive |
|---|---|---|
| Osteoporotic | Post menopausal females with Lumbar T score <-2.5 as determined by dual energy X ray absorbitometry Receives: Diagnostic Test: Dual energy X ray absorbtiometry | |
| Osteopenic | Post menopausal females with Lumbar T score -1 to -2.5 as determined by dual energy X ray absorbitometry Receives: Diagnostic Test: Dual energy X ray absorbtiometry | |
| Normal | Post menopausal females with T score >-1 as determined by dual energy X ray absorbitometry Receives: Diagnostic Test: Dual energy X ray absorbtiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiomorphometric indices of Cone beam computed tomography
CTCI(CT cortical index) CTMI(CT mental index) CTI(I)(CT mandibular index inferior) CTI(S)(CT mandibular index superior) values
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start24 Feb 2020
- Primary completionJan 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- 48 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365504
- Sponsor's protocol ID
- HarshaPopli
- Status last verified
- Apr 2020
- First submitted
- 24 Apr 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cone Beam Computed Tomography Derived Radiomorphometric Indices in Screening of Post-Menopausal Females for Osteoporosis.
- ClinicalTrials.gov ID
- NCT04365504
- Acronym / sponsor ID
- HarshaPopli
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Post menopausal females, Cone beam computed tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 28 Apr 2020 (actual)
- 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.
SUMMARY TITLE: "Efficacy of Cone Beam Computed Tomography derived radiomorphometric indices in screening of postmenopausal females for osteoporosis." RATIONALE: Osteoporosis is a disease of altered bone architecture affecting primarily elderly and middle-aged women and men, particularly post-menopausal women. It is responsible for a high number of fractures and poses a high financial burden in both developed and developing countries. In India, we are in a situation where an important, high- burden disease-osteoporosis is being neglected due to lack of facilities of detection, and unawareness about the other tools of assessing bone mineral density and fracture risk.
Few researchers have explored the use of radiomorphometric indices of Cone Beam Computed Tomography (CBCT) and have concluded that these can be used to differentiate between osteoporotic and non-osteoporotic patients. Increasing use of CBCT for various dental conditions, especially implant planning in older age group of patients, which is prone to osteoporosis, calls for the need for further exploration in this regard. The studies available in the literature are heterogenous in nature and reproducibility of the indices used has not been measured. Also, the sample size in each study was limited alongwith presence of selection bias. Thus, the present study will aim at assessing the efficacy of these indices in CBCT in an Indian population, the studies of which are sparse in literature, which shall aid in timely detection and therefore timely intervention to increase the quality of life and reduce morbidity and mortality occurring as a consequence of this disease.
RESEARCH QUESTION:
P: Population (Postmenopausal females with Osteoporosis i.e. DXA values below -2.5) I: Intervention (none) C: Control (Non-osteoporotic post-menopausal females) O: Outcome (CTCI, CTMI, CTI(S)and CTI(I) scores) T: Time Frame (1 year) S: Study Design (Cross sectional observational study) Setting in Haryana, India
Are radiomorphometric indices of CBCT useful for detecting the presence of postmenopausal osteoporosis?
Detailed description
Osteoporosis is a major health problem worldwide characterized by reduced bone mass and disrupted bone architecture that leads to increased susceptibility to fractures. It has become one of the leading causes of morbidity and mortality in older males and females, occurring more commonly in post-menopausal women.1 The prevalence of osteoporosis varies from 16% to 30% in Caucasian women with 39.7% women risked at sustaining a fracture once in a lifetime.1In a study conducted upon middle aged Indian women, a high prevalence of osteopenia (52%) and osteoporosis (29%) was found, with nutritional deficiency being the causative factor. 2 With such high prevalence rates, the need for timely detection cannot be overemphasized. The disease being largely asymptomatic, comes under the radar of the clinician only when a fracture occurs. The diagnosis is largely centered around measurement of bone mineral density by use of Single and dual X-ray absorptiometry (DXA), Ultrasonic measurement of bone, Computed tomography and Radiography with DXA being the gold standard and also the most commonly used technique.3 Dental radiographs are usually advised for a variety of dental diseases and conditions. This provides an opportunity to use dental radiographs as a screening tool for predicting osteoporosis. The role of pantomographs as a screening tool is well established.8,9 Cone beam computed tomography (CBCT), since its advent in 1999, has been specialised for dental use with its various advantages over conventional CT such as lower exposure dose, higher spatial resolution and space saving. Nowadays, CBCT is the modality of choice for patients requiring implant planning.it provides high resolution images in all three planes thereby allowing accurate quantitative measurements of hard structure. Over the recent years, many clinicians have attempted to establish CBCT as a modality to evaluate bone mineral content(BMC) and have concluded that lumbar vertebrae and femoral neck osteoporosis can be predicted accurately from the radiodensity values of the body of the mandible and it is possible to evaluate BMC from the voxel values of CBCT for dental implant treatment5,6.
However, there is still a controversy regarding use of CBCT for determination of bone quality. CBCT gray values give an approximate density and therefore cannot be expressed as HU as in conventional CT.
Few researchers have explored the use of radio morphometric indices such as computed tomography mandibular index superior (CTI(S)), computed tomography mandibular index inferior (CTI(I)), computed tomography cortical index (CTCI) and the computed tomography mental index (CTMI: inferior cortical width) and have been instrumental in establishing the fact that these indices can be used to differentiate between osteoporotic and non-osteoporotic patients7. Very few studies have been done using CBCT and no such study is available in the literature on an Indian population. Thus, this study will aim at determining the utility of these CBCT indices in detection of osteoporosis (confirmed through DXA scan) to aid in timely detection and therefore timely intervention to increase the quality of life and reduce morbidity and mortality occurring as a consequence of this disease.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osteoporotic | – | Diagnostic Test: Dual energy X ray absorbtiometryPost menopausal females with Lumbar T score <-2.5 as determined by dual energy X ray absorbitometry |
| Osteopenic | – | Diagnostic Test: Dual energy X ray absorbtiometryPost menopausal females with Lumbar T score -1 to -2.5 as determined by dual energy X ray absorbitometry |
| Normal | – | Diagnostic Test: Dual energy X ray absorbtiometryPost menopausal females with T score >-1 as determined by dual energy X ray absorbitometry |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-menopausal female patients visiting the Department of Oral medicine and Radiology for CBCT for any dental condition and fulfilling the inclusion criteria will be sent for a DXA scan to measure their bone mineral density. Based on their T scores, 3 groups shall be formed - Osteoporotic, Osteopenic and normal females consisting of a minimum of 16 patients in each group.
Key inclusion criteria (2 listed)
- Post-menopausal females with atleast 5 years since menopause.
- Patients undergoing CBCT and DXA within a span of 2 weeks.
Key exclusion criteria (3 listed)
- Patients in which pathology is detected at the site of measurements, hindering the calculation of indices.
- Patients undergoing hormone replacement therapy.
- Patients with history of diseases affecting bone density- diabetes, thyroid disease, osteoarthritis etc.
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 absorbtiometryThe primary clinical application of dual-energy x-ray absorptiometry (DXA or DEXA) is the measurement of bone mineral content (BMC, g) and bone mineral density (BMD, g/cm2) of the lumbar spine and proximal femur to assess risk for osteoporosis. | Diagnostic test | Normal, Osteopenic, Osteoporotic |
Primary outcome
Radiomorphometric indices of Cone beam computed tomography
Time frame: one year
CTCI(CT cortical index) CTMI(CT mental index) CTI(I)(CT mandibular index inferior) CTI(S)(CT mandibular index superior) values
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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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 Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 2 inclusion and 3 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 28 Apr 2020. 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 India. 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 Sanjay Tewari (01262283876, principalpgidsrohtak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiomorphometric indices of Cone beam computed tomography (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2020.