| CTRI Number |
CTRI/2024/03/064791 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
This is a type of Prospective, Observational, Investigator-initiated Study (IIS) to Investigate the Real-World Effectiveness and Safety of Denosumab in Patients with Osteoporosis due to Chronic Kidney Disease. |
|
Scientific Title of Study
|
A Prospective, Observational, Investigator-initiated Study (IIS) to Investigate the Real-World Effectiveness and Safety of Denosumab in Patients with Osteoporosis due to Chronic Kidney Disease. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 24/001 version 1.0 dated Jan 22, 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jatin Kothari |
| Designation |
Nephrologist |
| Affiliation |
Apex Kidney Care Pvt. Ltd. |
| Address |
Forgo House, Kanchpada, Next to Maruti Services Centre, Malad (W)
Mumbai
MAHARASHTRA
400064
India |
| Phone |
9820121010 |
| Fax |
9820121010 |
| Email |
Jkothari1970@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin Kothari |
| Designation |
Nephrologist |
| Affiliation |
Apex Kidney Care Pvt. Ltd. |
| Address |
Forgo House, Kanchpada, Next to Maruti Services Centre, Malad (W)
Mumbai
MAHARASHTRA
400064
India |
| Phone |
9820121010 |
| Fax |
9820121010 |
| Email |
Jkothari1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jatin Kothari |
| Designation |
Nephrologist |
| Affiliation |
Apex Kidney Care Pvt. Ltd. |
| Address |
Forgo House, Kanchpada, Next to Maruti Services Centre, Malad (W)
Mumbai
MAHARASHTRA
400064
India |
| Phone |
9820121010 |
| Fax |
9820121010 |
| Email |
Jkothari1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Jatin Kothari, Apex Kidney Care Pvt. Ltd., Forgo House, Kanchpada, Next to Maruti Services Centre, Malad (W), Mumbai. |
|
|
Primary Sponsor
|
| Name |
Dr Jatin Kothari |
| Address |
Apex Kidney Care Pvt. Ltd. Forgo House, Kanchpada, Next to Maruti Services Centre, Malad (W), Mumbai. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sanjeev Gulati Kidney Clinic |
Sector D3 3089, Opp. Fortis Hospital, Near Exit, Vasant Kunj, New Delhi, Delhi- 110070 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jatin Kothari |
Apex Kidney Care Pvt. Ltd. |
Department of Clinical
Research, Room
No. NA, Forgo House, Kanchpada, Next to Maruti Services Centre, Malad (W), Mumbai- 400064
Mumbai
MAHARASHTRA |
9820121010
Jkothari1970@gmail.com |
| Dr Sanjeev Gulati |
Kidney Clinic |
Department of Clinical Research, Room No. NA, Sector D3 3089, Opp. Fortis Hospital, Near Exit, Vasant Kunj, New Delhi, Delhi- 110070 India
New Delhi
DELHI |
9871600885
sgulati2002@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Good Society For Ethical Research, Dr. Sanjeev Gulati |
Approved |
| Indira IVF Hospital Ethics Committee, Dr. Jatin Kothari |
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
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
(1.)Age greater than 18 years.
(2.) Patients with at least 3 months Maintenance Hemodialysis (MHD).
(3.) Patients having a history of prior fracture in either the lumbar spine or the proximal femur whose T-score less than −1.0 in the LS and FN, or
(4.) T-score -2.5 to -4.0, or
(5.) Patients at high risk of bone fracture. Criteria for assigning high risk will be a previous history of fragility fracture, a family history of bone fracture in the proximal femur, or having a risk of bone
fracture during the past 10 years of greater than 15% according to the FRAX scale.
(6.) Baseline clinically acceptable physical examination.
(7.) Stable Electrocardiograph results at screening.
(8.) Patients receiving Denosumab as part of routine clinical practice. |
|
| ExclusionCriteria |
| Details |
(1.) Hypoparathyroidism, hypocalcemia (albumin adjusted serum Calcium conc. less than 8.5 mg/dl) or Vitamin D deficiency (25-hydroxyvitamin D level less than 30 ng/ml at screening)
(2.) Contraindications for receiving denosumab.
(3.) Known hypersensitivity to denosumab.
(4.) Patients who had been pretreated with Denosumab in the past 6 months
(5.) Active infection.
(6.) Known history of coronary artery disease (CAD), history of Stroke, a history of malignancy, other cardiac ailments active infection, pregnancy, and known alcohol or drug abuse at screening.
(7.) Patients currently on Teriparatide/ Bisphosphonates.
(8.) History of malignancy or parathyroidectomy.
(9.) Hypocalcemic (Ca less than 8.5 mg/dL), pregnant, lactating/nursing, at screening.
(10.) Physicians discretion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage change in BMD at lumbar spine and femur neck by dual x-ray absorptiometry (DEXA) |
from baseline to 6, 12 ,18 and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Incidence of any fracture at 1 and 2 years.
- Changes in Fracture Risk Assessment Tool (FRAX) score
-Changes in C- Terminal Polypeptide (CTX) from baseline to 6, 12,18 and 24 months
-Improvement in health-related quality of life (HRQOL) by EQ-5D from baseline to 0,6,12,18 and 24 months
-Incidence of adverse events and abnormal clinical findings |
baseline to 6, 12 ,18 and 24 months. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
05/04/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a prospective, single arm IIS in dialysis dependent CKD patients, diagnosed with Osteoporosis and receiving Denosumab as per clinical practice. The duration of study will be 24 months (18 months treatment + 6 months follow up). The collected data will be analysed to see the effectiveness and safety profile of denosumab in these patients. |