| CTRI Number |
CTRI/2025/09/095069 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Bone health in children with cerebral palsy compared to healthy children |
|
Scientific Title of Study
|
Bone Metabolism markers in cerebral palsy and age and sex matched apparently healthy population |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mitali Mahawar |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Ward 15 Department of Paediatrics , Maulana Azad Medical College , Bahadurshah Zafar Marg,Delhi
Central
DELHI
110002
India |
| Phone |
7987229961 |
| Fax |
|
| Email |
mitalimahawar07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica Juneja |
| Designation |
Head of Department and Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics,Maulana Azad Medical College,2,Bahadurshah Zafar Marg New Delhi
Central
DELHI
110002
India |
| Phone |
968604311 |
| Fax |
|
| Email |
drmonicajuneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica Juneja |
| Designation |
Head of Department and Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics,Maulana Azad Medical College,2,Bahadurshah Zafar Marg New Delhi
Central
DELHI
110002
India |
| Phone |
968604311 |
| Fax |
|
| Email |
drmonicajuneja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi ,2 Bahadurshah Zafar Marg,Pincode 110002,Central Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
2, Bahadurshah Zafar Marg, New Delhi-02 |
| Type of Sponsor |
Government medical college |
|
|
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 Mitali Mahawar |
Lok Nayak Hospital |
Room No.512-526, 5th floor Department of Paediatrics ,Maulana Azad Medical College
Central
DELHI |
7987229961
mitalimahawar07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals(Lok Nayak,GB Pant Institute of Post Graduate Medical Education (GIPMER)and Research hospital ,Guru Nayak Eye Centre,New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G80||Cerebral palsy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Group 1:Children diagnosed with Cerebral Palsy as per American Academy of Neurology Criteria(accompanied by primary caregiver
Group 2:Children attending the OPD for minor illness matched for age (+-6 months) and sex or siblings of children admitted in paediatrics wards |
|
| ExclusionCriteria |
| Details |
Group 1.
Children with known diagnosis of metabolic bone disorders
Children on bisphosphonates /more than 2 weeks of steroids
Children who have received megadoses of Vitamin D in the last 3 months.
Children on ketogenic diet
Children after onset of puberty
Children with documented fractures in last 12 months
Group2
Children after onset of puberty
Children with documented fractures in the last 12 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean/median serum levels of TP1NP(Total procollagen type 1 N terminal propeptide) and Beta-cross laps(B-CTX) levels in ambulatory and non-ambulatory children with cerebral Palsy and age and sex matched apparently healthy population |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in Mean/Median serum levels of other bone metabolism markers(vitamin D/ PTH: para thyroid hormone/ALP: alkaline phosphatase/serum calcium/serum phosphate/osteocalcin) in children with cerebral Palsy & age & sex matched, apparently healthy population |
Baseline |
| Mean difference in dietary intake of calcium in these two groups |
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/10/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cerebral Palsy has been described as a group of permanent disorders of development of movement and posture, leading to limitation of activity, which are attributed to non-progressive alterations in the developing fetal or infant brain. Children with CP experience, comorbidities like musculoskeletal disorders, connective tissue diseases, respiratory disease, diseases, and infections. Bone health in CP can be affected by nutritional status, hormonal parameters and ambulatory status of the child. Altered bone metabolism in children with CP may lead to raise markers of bone formation and resorption. Estimation of these markers can help in the assessment of bone formation and resorption in a non-invasive manner. Children with CP have increased risk of fractures associated with low bone density. Despite existing research gaps, remain in understanding how different levels of motor function(ambulatory versus non-ambulatory) influence bone metabolism in CP. Also studies that compare to groups to match healthy children while controlling for confounders such as age, sex, and nutritional status are limited. By evaluating the relationship between mobility status and bone metabolism, This research can contribute to early identification of at risk individuals and help in guiding interventions to improve bone health in children with CP. |