| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|