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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.

 
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