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CTRI Number  CTRI/2025/11/096754 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 31/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   A Study on how weak bones, muscles, and memory problems interact in seniors with hip fractures 
Scientific Title of Study   Assessment of Osteosarcopenia Frailty and Cognitive status in Elderly with Hip Fractures: A Prospective Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harsh Jain 
Designation  PG Student 
Affiliation  All India Institute of Medical Sciences 
Address  Orthopaedics department, AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  8433235081  
Fax    
Email  jain0210harsh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof B. Chowdhury 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  JPNATC TRAUMA CENTRE AIIMS NEW DELHI

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  buddhadevchowdhuryaiiimstc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Harsh Jain 
Designation  PG Student 
Affiliation  All India Institute of Medical Sciences 
Address  ORTHOPAEDICS DEPARTMENT AIIMS New Delhi

New Delhi
DELHI
110029
India 
Phone  8433235081  
Fax    
Email  jain0210harsh@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Ansari nagar east New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 
Harsh Jain  Jai Prakash Narayan Apex Trauma Centre, AIIMS  DEPARTMENT OF ORTHOPAEDICS
New Delhi
DELHI 		 8433235081

jain0210harsh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age more than or equal to 60 years.
Hip fracture diagnosed on X Ray
Consent to participate in the study
Walking patients prior to fracture, with or without support 
 
ExclusionCriteria 
Details  Pathological fractures (malignancy related)
Patients with terminal illnesses (end stage malignancy, severe chronic lung disease or heart
failure)
Patients with severe cognitive impairment precluding assessment.
Polytrauma patients involving more than or equal to 2 systems
Those who did not give consent for the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 To determine the prevalence of osteosarcopenia in elderly patients (more than or equal to 60 years) presenting with hip fracture and compare it with elderly presenting with other complaints

2 To evaluate the association of osteosarcopenia, frailty, and nutritional status with clinical outcomes in hip fracture patients over a 6 month follow up period 		 1 Prevalence will be assessed at the baseline

2 Outcomes will be assessed at 4 weeks and 6 months

 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the association between
prevalence of sarcopenia & osteoporosis in
patients with hip fracture.
2. To determine the prevalence of delirium
and association of cognitive status with
outcomes in hip fracture.
3. To determine the histopathological
composition of skeletal muscle in elderly hip
fracture patients & correlate these findings
with osteosarcopenia & clinical outcomes 		 1. Prevalence of sarcopenia, osteoporosis, delirium & cognitive status will be assessed at baseline

2. Histopathological analysis using biopsy will be assessed at baseline

3. Clinical & functional outcomes will be assessed at 4 weeks & 6 months 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   01/12/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jain0210harsh@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

This study aims to assess the prevalence and clinical impact of osteosarcopenia, frailty, and cognitive impairment in elderly patients (more than or equal to 60 years) presenting with hip fractures at AIIMS, New Delhi. It is a comparative cross-sectional and prospective cohort study enrolling 66 hip fracture patients.

Each participant will undergo detailed geriatric assessment including frailty (CFS), cognition (IQCODE), delirium (CAM), nutritional status (MNASF), and evaluation for sarcopenia using handgrip strength, DEXA, and CT-based psoas muscle index. In surgical patients, muscle biopsy of the vastus lateralis will be analyzed histologically to correlate structural muscle changes with clinical sarcopenia. Bone density will be assessed by DEXA to identify osteopenia/osteoporosis.

Participants will be followed for 6 months post surgery to evaluate outcomes including functional recovery (Modified Harris Hip Score, Timed Up and Go test) and mortality.

The study seeks to generate Indian data on osteosarcopenia and frailty in geriatric hip fractures and to determine how these syndromes influence recovery and outcomes, guiding development of integrated orthogeriatric care strategies for elderly fracture patients.


 
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