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CTRI Number  CTRI/2026/02/104881 [Registered on: 26/02/2026] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Bone Health in Healthy College Students of Telangana. 
Scientific Title of Study   The Invisible Threat: Burden of Low Bone Mass in apparently healthy college going young adults of Telangana 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepankar Satapathy 
Designation  Assistant Professor, Department Of Orthopaedics 
Affiliation  AIIMS Bibinagar, Hyderabad 
Address  Faculty, Department of Orthopaedics, AIIMS Bibinagar, Hyderabad Metropolitan Region

Nalgonda
TELANGANA
508126
India 
Phone  7873777333  
Fax    
Email  dipun86@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Deepankar Satapathy 
Designation  Assistant Professor, Department Of Orthopaedics 
Affiliation  AIIMS Bibinagar, Hyderabad 
Address  Faculty, Department of Orthopaedics, AIIMS Bibinagar, Hyderabad Metropolitan Region

Nalgonda
TELANGANA
508126
India 
Phone  7873777333  
Fax    
Email  dipun86@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deepankar Satapathy 
Designation  Assistant Professor, Department Of Orthopaedics 
Affiliation  AIIMS Bibinagar, Hyderabad 
Address  Faculty, Department of Orthopaedics, AIIMS Bibinagar, Hyderabad Metropolitan Region

Nalgonda
TELANGANA
508126
India 
Phone  7873777333  
Fax    
Email  dipun86@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bibinagar, Hyderabad Metropolitan Region, Telangana, India- 508126  
 
Primary Sponsor  
Name  AIIMS Bibinagar  
Address  AIIMS Bibinagar, Hyderabad Metropolitan Region, Telangana, India, Pin - 508126 
Type of Sponsor  Research institution 
 
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 
Dr Deepankar Satapathy  AIIMS Bibinagar  Department Of Orthopaedics, OPD Room No - 32, AIIMS Bibinagar, Hyderabad Metropolitan Region, Telangana, India , 508126
Nalgonda
TELANGANA 		 7873777333

dipun86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMSBBNIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Bone Mass Screening intervention 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1) All apparently healthy college going young adults of Telangana between the age of 18- 30 years who are willing to give consent to take part in the study will be recruited.
2) Young adult patients who come to orthopedic opd for minor ailments will be recruited with their consent
 
 
ExclusionCriteria 
Details  1) Subjects who have taken high dose Vitamin D in last 3 months.
2) Chronic inflammatory conditions like IBD, Coeliac disease, Malabsorption syndrome, connective tissue diseases, rheumatoid arthritis.
3) Endocrine diseases like DM, Cushings, hyperparathyroidism,.
4) Pregnancy and lactation
5) Neuromuscular and metabolic conditions.
6) Those taking medications like glucocorticoids, cylosporines, high dose thyroxine, heparin, cytotoxic chemotherapy
7) Previous spine and limb fracture history. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the proportion of low bone mass (Osteoporosis and Osteopenia) among apparently healthy college going young adults of Telangana.   Baseline only. At first visit only. 
 
Secondary Outcome  
Outcome  TimePoints 
1)To determine the relationship between low bone mass & serum blood markers in apparently healthy college going young adults of Telangana.
2)To study about fat distribution, muscle mass & to estimate prevalence of sarcopenia in apparently healthy college going young adults of Telangana. (if feasible)

 		 Baseline only. At first visit only. 
 
Target Sample Size   Total Sample Size="154"
Sample Size from India="154" 
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)   10/03/2026 
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 - 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 [dipun86@gmail.com].

  6. For how long will this data be available start date provided 28-02-2027 and end date provided 28-02-2030?
    Response - Immediately following publication. No end date.

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

Osteoporosis is global health problem and India is no exception to it. Osteoporosis and fragility fractures are the major causes of mortality, morbidity, and cost of medical care. Multiple studies have been performed on prevalence of osteopenia and osteoporosis in older population, however, there is a paucity of literature about the factors affecting low BMD in young apparently healthy Indian population.

Primary objective is to estimate the factors affecting low bone mass among apparently healthy college going young adults of Telangana. Secondary objective is to determine the relationship between low bone mass and serum blood markers and other measured parameters.

This will be a cross-sectional study that will be initiated after approval from the Institutional Ethics Committee. The study will be conducted at Departments of Orthopaedics, AIIMS Bibinagar, Hyderabad. Study participants will be recruited after a written informed consent. DEXA scan, serum Vit D, PTH, Serum Calcium, Phosphorus and Alkaline Phosphatase levels will be performed, assessed and analyzed in relation to BMD.

With current lifestyle of youth with low level of outdoor activities we are expecting high prevalence of low bone mass in young Indian adults. By analyzing the factors affecting Low BMD, we can make huge impact on bone health of our future generation by taking appropriate measures and therefore we can offload our health care system from the complications arising out of osteoporosis.

 
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