| CTRI Number |
CTRI/2025/10/096547 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the Knowledge regarding bone health and readiness for undergoing screening [Bone mineral density screening] among working women from selected institutions of Udupi district Karnataka |
|
Scientific Title of Study
|
A cross sectional study to assess the knowledge regarding bone mineral density [BMD] & readiness for screening among working women at selected institutions of Udupi district Karnataka. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaniska Dhakal Sharma |
| Designation |
Student |
| Affiliation |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal |
| Address |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal
Manipal College of Nursing,Room No 400A, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8158997290 |
| Fax |
|
| Email |
sharmakaniska591@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Judith A Noronha |
| Designation |
Professor/Dean |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Obstetrics and gynaecology Nursing MCON MAHE Manipal.
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448506594 |
| Fax |
|
| Email |
judith.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushmitha R Karkada |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Nursing, MAHE, Manipal |
| Address |
Department of Obstetrics and gynaecology Nursing, MCON MAHE, Manipal.
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9964144224 |
| Fax |
|
| Email |
sushmitha.karkada@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital MAHE Manipal India (pin code 576104) |
|
|
Primary Sponsor
|
| Name |
Kaniska Dhakal Sharma |
| Address |
Manipal College of Nursing Manipal Academy of Higher Education Manipal Udupi district Karnataka India
pin code - 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sushmitha R Karkada |
Kasturba Hospital |
Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, Nursing department, room number 401
Udupi
KARNATAKA |
9964144224
sushmitha.karkada@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Female |
| Details |
Women who are willing to participate providing informed consent
Women falling under the age group of 30-58 years
Women who will be available at the time of data collection
Women who understands and can read and write in english
|
|
| ExclusionCriteria |
| Details |
Women who have conceived/pregnant within the provided age group
Women who are already diagnosed with osteoporosis and have already undergone screening for BMD
Women not willing to participate in the research study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge on Bone Mineral Density and Readiness for screening |
eight weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="428"
Sample Size from India="428"
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)
|
26/01/2026 |
| 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="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
|
Low bone mineral density is characterised by a BMD that is between 1.0 and 2.5 standard deviations (SDs) below the mean BMD for a young adult reference population. This condition can lead to osteopenia and osteoporosis, both of which significantly increase the risk of fractures and other health complications.However, there is a need for health awareness programs to educate each woman about the importance of BMD screening and the its potential benefits of early detection and treatment. The awareness of low BMD and readiness for screening can be influenced by various factors, including health literacy, prevalence, risk factors, preventive measures, early screening, life style modifications, nutrition and perceived susceptibility to osteoporosis.This study will contribute to the existing body of knowledge by providing insights into the current awareness and readiness for BMD screening among women in institutes of MAHE. This information can be used to develop needed interventions in order to improve osteoporosis screening and treatment uptake, ultimately boosting the bone health outcomes for women in this population. |