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CTRI Number  CTRI/2023/03/051127 [Registered on: 28/03/2023] Trial Registered Prospectively
Last Modified On: 11/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Low bone density in kidney disease patients 
Scientific Title of Study   A study of determinants of low bone mineral density in patients with advanced chronic kidney disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratima Namdeo Acharya 
Designation  DNB Resident 
Affiliation  King Edward Memorial Hospital, Pune 
Address  Renal Unit Department, 2nd floor, Diamond Jubilee Building King Edward Memorial Hospital, Sardar Moodliar Road, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9403652162  
Fax    
Email  drpratima99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Valentine Lobo 
Designation  Consultant Nephrologist 
Affiliation  King Edward Memorial Hospital, Pune 
Address  Renal Unit Department, 2nd floor, Diamond Jubilee Building King Edward Memorial Hospital, Sardar Moodliar Road, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9049232489  
Fax    
Email  valentinelobo702@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Valentine Lobo 
Designation  Consultant Nephrologist 
Affiliation  King Edward Memorial Hospital, Pune 
Address  Renal Unit Department, 2nd floor, Diamond Jubilee Building King Edward Memorial Hospital, Sardar Moodliar Road, Rasta Peth, Pune

Pune
MAHARASHTRA
411011
India 
Phone  9049232489  
Fax    
Email  valentinelobo702@gmail.com  
 
Source of Monetary or Material Support  
KEM Hospital Research Center 3rd floor, TDH Building KEM Hospital, Sardar Moodliar Road, Rasta Peth, Pune 411011 
 
Primary Sponsor  
Name  King Edward Memorial Hospital, Pune 
Address  Moodliar Road, Rasta Peth, Pune-411011 
Type of Sponsor  Private hospital/clinic 
 
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 
Dr Pratima Acharya  KEM Hospital, Pune  Renal Unit Department, 5th floor, Diamond Jubilee Building, KEM Hospital, Sardar Moodliar Road, Rasta Peth, Pune 411011
Pune
MAHARASHTRA 
9403652162

drpratima99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KEM Hospital Research Center Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients with age >18 years with CKD stage 4 and 5
2.Patients with CKD 5D on Dialysis (PD and HD) started within last 12 months 
 
ExclusionCriteria 
Details  1.Post-renal transplant patients
2.Pregnancy
3.Patients with previous spine surgeries
4.Patients on osteoporosis therapy
5.Use of corticosteroids within last 6 months 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Prevalence of low BMD in patients with advanced chronic kidney disease  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
factors associated with low BMD  18 months 
 
Target Sample Size   Total Sample Size="340"
Sample Size from India="340" 
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)   10/04/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NOT YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Advanced stages of chronic kidney disease (CKD) are associated with abnormalities in bone and mineral health of the patient. They may manifest as decreased bone mineral density, abnormalities in bone volume, calcification of vascular and/or soft tissues. Low bone mineral density (BMD) as measured by dual-energy X-ray absorptiometry, predicts the risk of fragility fracture. Skeletal fractures are important cause of CKD-related morbidity.

Despite of high prevalence of decreased bone mineral density in CKD, diagnosis and role of bone mineral density remain understudied in India. Further, the studies are needed to determine the factors associated with low BMD.

In this study, we will measure BMD by DEXA scan and determine the prevalence of low BMD in advanced CKD in Indian population. With the use of statistical tests, we will observe relationship between low BMD and Stage of CKD, biochemical markers, age, gender and BMI and various other determinants of low BMD.

This cross-sectional observational study will be carried out over period of 18 months and will include adult patients with advanced CKD, admitted in wards or seen in outpatient of KEM Hospital, Pune. Post renal transplant patients, pregnant, patients with previous spine surgery and those on osteoporosis therapy will be excluded.

We expect to determine prevalence of low BMD in advanced CKD in Indian population and establish relationship between low BMD with stage of CKD, biochemical markers and demographical parameters which will help in early suspicion and diagnosis of CKD-MBD and effect of modifications in determinants on clinical outcome.

 
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