| CTRI Number |
CTRI/2018/10/016060 [Registered on: 17/10/2018] Trial Registered Prospectively |
| Last Modified On: |
16/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Determining Bone strength measurement standards- comparing with existing standards to look for bone loss |
|
Scientific Title of Study
|
Bone Mineral Density by Quantitative CT-Determination of local population reference standard and comparing with existing standards for Osteoporosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prakashini K |
| Designation |
Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
Department of Radiodiagnosis, Kasturba medical college, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
9845053325 |
| Fax |
|
| Email |
docprakashinik@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Prakashini K |
| Designation |
Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
Department of Radiodiagnosis, Kasturba medical college, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
9845053325 |
| Fax |
|
| Email |
docprakashinik@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Hemanth Kumar Deevi |
| Designation |
Junior Resident, Department of Radiodiagnosis |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
Department of Radiodiagnosis, Kasturba medical college, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104
Udupi KARNATAKA 576104 India |
| Phone |
9441500794 |
| Fax |
|
| Email |
deevihemu@gmail.com |
|
|
Source of Monetary or Material Support
|
| KASTURBA MEDICAL COLLEGE,
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
KASTURBA MEDICAL COLLEGE |
| Address |
kasturba medical college, Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Hemanth Kumar Deevi |
Kasturba medical college |
Main CT room, near trauma triage, Kasturba medical college,
Tiger Circle Road, Madhav Nagar, Manipal, Karnataka 576104 Udupi KARNATAKA |
9441500794
deevihemu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (Registration no. ECR/146/Inst/KA/2013/RR-16) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing a CT study which includes T12, L1 & L2 vertebrae at the request of their physician/ surgeon and are free of obvious bone pathology. |
|
| ExclusionCriteria |
| Details |
Genetic disorders
Hypogonadal states
Endocrine disorders
Gastrointestinal disorders
Hematologic disorders
Rheumatic and autoimmune disorders
On treatment for Depression
On treatment for Epilepsy
On chemotherapy
Chronic Diseases: metabolic diseases like hyper and hypothyroidism, Malabsorption syndromes
Long term drug intakes: - Of steroids /contraceptives/ chemotherapy
History of - Pregnancy within last 12 months or breastfeeding / Chronic immobilization / Joint problems like rheumatoid arthritis etc. / Use of any radio isotope for clinical investigation in the last one month
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The mean bone mineral density of local population along with the standard deviation can be compared to currently used UCSF standard which are being used in QCT BMD of phillips.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To estimate how much percentage of patients are wrongly diagnosed as osteoporosis when still in normal range when compared to local population reference |
1 year |
|
|
Target Sample Size
|
Total Sample Size="800" Sample Size from India="800"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Measurement of Thoracic Bone Mineral Density with Quantitative CT
Matthew J. Budoff , Yasmin S. Hamirani , Yanlin L. Gao , Hussain Ismaeel , Ferdinand R. Flores , Janis Child , Sivi Carson , James N. Nee , Songshou Mao
The impact of US versus Indian BMD reference standards on the diagnosis of osteoporosis among South Asian Indians living in the United States
Alexander Melamed, Eric Vittinghoff, Usha Sriram, Ann V. Schwartz and Alka M. Kanaya
Comparison of vertebral and femoral bone mineral density in adult females
Han Seong Choe, Jae Hong Lee, PhD, PT, Dong Ki Min, PhD, PT, and So Hong Shin
Population based reference standards of Peak Bone Mineral Density of Indian males and females – an ICMR multi-centre task force study
Opportunistic screening for osteoporosis by routine CT in Southern Europe.
Alacreu E, Moratal D, Arana E
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Measurement of Thoracic Bone Mineral Density with Quantitative CT Matthew J. Budoff , Yasmin S. Hamirani , Yanlin L. Gao , Hussain Ismaeel , Ferdinand R. Flores , Janis Child , Sivi Carson , James N. Nee , Songshou Mao , When we compared the lumbar quantitative CT measurements with the thoracic quantitative CT results, we found that the T scores derived by using thoracic quantitative CT were lower, however there is a significant positive association between the BMD values obtained from the thoracic spine vertebrae and those obtained from the lumbar spine vertebrae The impact of US versus Indian BMD reference standards on the diagnosis of osteoporosis among South Asian Indians living in the United States Alexander Melamed, Eric Vittinghoff, Usha Sriram, Ann V. Schwartz and Alka M. Kanaya Compared to reference values based on US whites, Indian-based standards more frequently classified US-based South Asian Indians as having normal bone density levels at the total hip and lumbar spine. The use of Indian reference standards reclassified up to 40% of subjects to a BMD category better than that assigned using US white-based values. Comparison of vertebral and femoral bone mineral density in adult females Han Seong Choe, Jae Hong Lee, PhD, PT, Dong Ki Min, PhD, PT, and So Hong Shin, MS all three groups (normal, osteopenia, osteoporosis) showed the highest correlation between lumbar and trochanter T-scores, consistent with the findings of a precedent study that showed the lumbar and trochanter BMD measurements were highly correlated, likely because the ossein of the trochanter has characteristics similar to those of the trabecular bone Population based reference standards of Peak Bone Mineral Density of Indian males and females – an ICMR multi-centre task force study it was clear that the pooled estimates of BMD of healthy normal males and females as well as their Peak Bone Mineral Density at the three sites namely, hip, forearm and spine were found to be significantly lower than the corresponding NHANES III and Hologic normative values. The demographic parameters such as religion, father’s occupation during childhood, self occupation, caste and dental mottling had no impact on BMD at any of the three sites. The nature of activity performed significantly affected BMD at forearm and spine both in males and females regardless of the centres. Among the physical and clinical parameters, age, age at menarche and age at first birth in females had no impact on BMD at any site. Opportunistic screening for osteoporosis by routine CT in Southern Europe. Alacreu E, Moratal D, Arana E Abdominal CT images obtained for other reasons can identify patients with osteoporosis BMD without additional radiation exposure or cost. Uncalibrated values at L1 can detect more osteoporosis patients with spinal compression fractures than DXA in oncologic patients. |