| CTRI Number |
CTRI/2025/01/079281 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Finding out osteoporosis among adults below 50 years. |
|
Scientific Title of Study
|
Screening for Osteoporosis among adults in a hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Merlyn Priya Moras |
| Designation |
Post Graduate Student (Nursing) |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing, Medical Surgical Nursing, 1st M.Sc. Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9535857530 |
| Fax |
|
| Email |
morasmerlyn88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Sandra J Saldanha |
| Designation |
Associate Professor |
| Affiliation |
Father Muller College of Nursing |
| Address |
Father Muller College of Nursing, Child Health Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9900412965 |
| Fax |
|
| Email |
sanjyothsal@fathermuller.in |
|
Details of Contact Person
Public Query
|
| Name |
Daisy PJ |
| Designation |
Post Graduate Student (Nursing) |
| Affiliation |
Rajiv Gandhi University of Health Sciences |
| Address |
Father Muller College of Nursing, Community Health Nursing, 1st M.Sc. Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9188279221 |
| Fax |
|
| Email |
srroshninicss@gmail.com |
|
|
Source of Monetary or Material Support
|
| self funded, Father Muller College of Nursing, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India - 575002 |
|
|
Primary Sponsor
|
| Name |
Mrs Merlyn Priya Moras |
| Address |
Father Muller College of Nursing, Medical Surgical Nursing, 1st Msc Nursing, Kankanady, Dakshina Kannada, Mangaluru, Karnataka, India |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Daisy P J |
Father Muller College of Nursing, Community Health Nursing, 1st Msc Nursing, Kankanady, Dakshina Kannada, Mangaluru, Karnataka, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mrs Sandra Saldanha |
Father Muller Medical College Hospital |
Department of Orthopedics and OBG, Kankanady, Mangaluru, Dakshina Kannada, Karnataka, India- 575002
Dakshina Kannada
KARNATAKA |
9900412965
sanjyothsal@fathermuller.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethical Committee (FMIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
any person who wishes to screen for osteoporosis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
this study is descriptive. So there is no comparator agent |
| Intervention |
NIL |
this study is descriptive. so there is no intervention |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
healthy adults those who walk in to the OPD area, who wishes to check their Bone Mineral Density would be undergone through screening for Osteoporosis |
|
| ExclusionCriteria |
| Details |
those who are already diagnosed with osteoporosis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ultrasound Bone Dnsitometer CM-200
Normal score : -1 and above
Osteopenia (low bone mass)score: -1.1 to -2.4
Osteoporosis score : -2.5 and below
|
at baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| osteoporosis among young adults |
baseline |
|
|
Target Sample Size
|
Total Sample Size="97"
Sample Size from India="97"
Final Enrollment numbers achieved (Total)= "3"
Final Enrollment numbers achieved (India)="3" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Early screening would help in determining the extent of osteoporosis and further aid in intervention towards its prevention among young adults. With this aim the researcher felt a need to find out the prevalance of Osteoporosis among young adults in the current setting. Identifying the risk may help the individuals with osteopenia to reverse the condition as much as possible through diet, lifestyle modification or atleast by preventing the risk of fracture. |