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CTRI Number  CTRI/2025/12/099957 [Registered on: 29/12/2025] Trial Registered Prospectively
Last Modified On: 28/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of Adherence to Oral Calcium and Vitamin D Supplementation and Barriers Among Patients with Osteoporosis 
Scientific Title of Study   Assessment of compliance with oral Calcium and Vitamin D and exploration of barriers for patients with Osteoporosis.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavin Khatri 
Designation  Assistant Professor  
Affiliation  PGIMER Satellite Centre Sangrur 
Address  room no 304 department of orthopedics Postgraduate Institute of Medical Education and Research (PGIMER Satellite Centre Sangrur Department of Orthopaedic

Sangrur
PUNJAB
148001
India 
Phone  07837540662  
Fax    
Email  kavinkhatri84@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kavin Khatri 
Designation  Assistant Professor  
Affiliation  PGIMER Satellite Centre Sangrur 
Address  room no 304 departement of orthopedics Postgraduate Institute of Medical Education and Research (PGIMER Satellite Centre Sangrur Department of Orthopaedic

Sangrur
PUNJAB
148001
India 
Phone  07837540662  
Fax    
Email  kavinkhatri84@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kavin Khatri 
Designation  Assistant Professor  
Affiliation  PGIMER Satellite Centre Sangrur 
Address  room no 304 departemnt of orthoepdics Postgraduate Institute of Medical Education and Research (PGIMER Satellite Centre Sangrur Department of Orthopaedic

Sangrur
PUNJAB
148001
India 
Phone  07837540662  
Fax    
Email  kavinkhatri84@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Postgraduate institute of medical education and research chandigarh 
Address  room no 6006, ethics committee, PGIMER, Sector -12 , chandigarh 
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 
dr Kavin Khatri  Postgraduate Institute of Medical Education and Research Satellite Centre Sangrur  room no 304 Department of Orthopaedics PGIMER Satellite Centre GHABDHAN Sangrur Punjab 148001
Sangrur
PUNJAB 
07837540662

kavinkhatri84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER CHANDIGARH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M839||Adult osteomalacia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Willingness to provide informed consent 
 
ExclusionCriteria 
Details  Pregnant or lactating females 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary aim of the study is to evaluate the effect of a patient-focused motivation strategy on the one-year adherence to calcium and vitamin D supplementation.
 
one , three , six and tweleve months  
 
Secondary Outcome  
Outcome  TimePoints 
To identify the other possible factors that can influence patient’s compliance, including personal preferences towards specific dosages or regimens in the supplementation & adverse effects.
 
one , three , six, & twelve months  
 
Target Sample Size   Total Sample Size="582"
Sample Size from India="582" 
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)   30/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/01/2026 
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 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  

Osteoporosis is a condition where bones become weak and fragile, increasing the risk of fractures. To prevent and manage this condition, doctors often recommend supplements like calcium and vitamin D. However, many patients do not take these supplements as prescribed, which reduces their effectiveness and raises the chance of fractures. This study aims to find out how many patients stick to their calcium and vitamin D supplements and what barriers prevent them from doing so. The study will also test if regular follow-up visits with healthcare providers every three months can improve adherence to these supplements. Patients diagnosed with osteoporosis or osteopenia (weaker-than-normal bones) will be enrolled and followed for one year. During this time, their adherence to the prescribed supplements will be measured using simple tools, including questionnaires and tracking the amount of medication they use. The study will also identify factors like personal preferences, side effects, or other challenges that may affect their adherence. By understanding these barriers and testing ways to improve compliance, this research hopes to provide better strategies to help patients take their supplements regularly. This could reduce the risk of fractures and improve the overall health of people with osteoporosis. Participants can join voluntarily and may withdraw at any time without affecting their treatment. Their information will be kept confidential. Findings from this study will be shared in scientific journals to help improve care for osteoporosis patients worldwide.

 

 
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