Efficacy of Cone Beam Computed Tomography in Diagnosing Osteoporosis
1 other identifier
observational
48
1 country
1
Brief 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. 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2020
CompletedFirst Submitted
Initial submission to the registry
April 24, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedApril 28, 2020
April 1, 2020
10 months
April 24, 2020
April 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
one year
Study Arms (3)
Osteoporotic
Post menopausal females with Lumbar T score \<-2.5 as determined by dual energy X ray absorbitometry
Osteopenic
Post menopausal females with Lumbar T score -1 to -2.5 as determined by dual energy X ray absorbitometry
Normal
Post menopausal females with T score \>-1 as determined by dual energy X ray absorbitometry
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Post-menopausal females with atleast 5 years since menopause.
- Patients undergoing CBCT and DXA within a span of 2 weeks.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Weeks
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2020
First Posted
April 28, 2020
Study Start
February 24, 2020
Primary Completion
January 1, 2021
Study Completion
March 1, 2021
Last Updated
April 28, 2020
Record last verified: 2020-04