| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
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. |