| CTRI Number |
CTRI/2023/08/055954 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
08/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Bone diseases among children exposed to steroids as part of their treatment |
|
Scientific Title of Study
|
Vertebral Fragility Fracture and Osteoporosis among children exposed to glucocorticoids |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Koushik H |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatrics,
Kasturba Medical College, Manipal,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9242308804 |
| Fax |
0820-2571927 |
| Email |
koushik.h@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Koushik H |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatrics,
Kasturba Medical College, Manipal,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9242308804 |
| Fax |
0820-2571927 |
| Email |
koushik.h@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Koushik H |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Pediatrics,
Kasturba Medical College, Manipal,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9242308804 |
| Fax |
0820-2571927 |
| Email |
koushik.h@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Health Research
Indian Red Cross Building
Red Cross Road, New Delhi -110001 |
|
|
Primary Sponsor
|
| Name |
Department of Health Research |
| Address |
Administrative Officer
Project Implementation Unit
Department of Health Research
Indian Red Cross Building
Red Cross Road, New Delhi -110001 |
| Type of Sponsor |
Government funding agency |
|
|
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 Koushik H |
Kasturba Medical College, Manipal |
Department of Paediatrics, Kasturba Hospital, Madhav Nagar, Manipal - 576104
Udupi
KARNATAKA |
9242308804
0820-2571927
koushik.h@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy age matched controls will be selected for estimation of bone mineral density, vit d and calcium status. |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], (2) ICD-10 Condition: M084||Pauciarticular juvenile rheumatoidarthritis, (3) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality, (4) ICD-10 Condition: M321||Systemic lupus erythematosus withorgan or system involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children with the following three diseases, who are either newly diagnosed or on follow up will be recruited:
1. Rheumatic Disease (RD):
Children between 1 month to 18 years with diagnosis of Juvenile Idiopathic Arthritis (JIA), Systemic Lupus Erythematosus (SLE). (13)(14).
2. Nephrotic syndrome (NS):
Children between 1 month to 18 years with diagnosis of Nephrotic syndrome (first episode, relapse, steroid dependent, steroid resistant). (15).
3. Acute Lymphoblastic leukemia (ALL):
Children between 1 month to 18 years with diagnosis of Acute Lymphoblastic Leukemia (16).
Newly diagnosed cases of all three diseases will be included within 14 days of diagnosis. The follow up cases will be included if they have received at least 3 months of daily or alternate day steroid therapy, more than physiological replacement dose (>2 mg/m2/day prednisolone equivalent) in last 6 months.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Incidence of VF & GIO among children exposed to steroids |
At enrolment, 6 and 12 months after enrollment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the risk factors for development of VF & osteoporosis
2. To study the progression of VF and osteoporosis among those with VF at the time of diagnosis
3. Correlation of lumbar spine BMD with vertebral fragility fracture
|
At recruitement, 6 months & 1 year after recruitement |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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)
|
01/08/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
1.
Objectives:
Primary:
1.
To study the incidence of
vertebral fracture and osteoporosis among children exposed to glucocorticoids
Secondary:
1. To
study the risk factors for development of VF and osteoporosis
2. To
study the progression of VF and osteoporosis among those with VF at the time of
diagnosis
3. Correlation
of lumbar spine BMD with vertebral fragility fracture
2.
Summary of the proposed
research project (in only 200 words):
2.1 Background
Glucocorticoids (GC)
are main stay of immunosuppression commonly used in childhood. Glucocorticoids
can adversely affect bone health and result in vertebral fracture(VF) and GC
induced osteoporosis (GIO), however evidence regarding burden of disease, screening
and management strategies in pediatric age group is limited and largely guided
by adult studies.
Common tools used in
screening of osteoporosis - bone mineral density (BMD), may not be sufficient, because
of lack of ethnicity specific data, possibility of vertebral fracture in the
presence of normal BMD, technical difficulty in young children. Hence, now a day’s
osteoporosis diagnosis is often VF focused, which is an easy and effective tool.
2.2 Research question
1. To
study the incidence and progression of VF, GIO
and factors influencing them.
2.3 Methodology
Children exposed to
steroids for significant duration will be enrolled. Baseline demographic -
clinical data, bone markers, vertebral fracture assessment (VFA), lumbar spine
BMD (LSBMD) will be documented. Follow up VFA, LS BMD will be done 6 and 12
months after baseline data to document progression of VF or GIO if any.
2.4 Proposed outcome
1. Incidence of VF and GIO among children exposed to steroids
2. Risk
factors for development of VF and osteoporosis
3. Progression
of VF and osteoporosis among those with VF at the time of diagnosis
4. Correlation
of lumbar spine BMD with vertebral fragility fracture |