CTRI

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CTRI Number

CTRI/2025/08/093788 [Registered on: 27/08/2025] Trial Registered Prospectively

Last Modified On:

26/08/2025

Post Graduate Thesis

No

Type of Trial

Observational

Type of Study

Device development and validation

Study Design

Other

Public Title of Study

Health for bone health

Scientific Title of Study

Reconfiguration of management of osteoporosis in children and adults a shift in paradigm from treatment to prevention using a novel biotechnology device Swastya for Asthi Tavasya

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Rajani Mullerpatan
Designation	Professor Director
Affiliation	MGM School of Physiotherapy MGM Institute of Health Sciences
Address	1st Floor room no-115 Out Patient Department Department of Physiotherapy MGM Hospital, Kamothe Plot no 1 and 2 Sector 1 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA Raigarh MAHARASHTRA 410209 India
Phone	02227437866
Fax
Email	rmullerpatan@mgmsopnm.edu.in

Details of Contact Person
Scientific Query

Name	Dr Rajani Mullerpatan
Designation	Professor Director
Affiliation	MGM School of Physiotherapy MGM Institute of Health Sciences
Address	1st Floor room no-115 Out Patient Department Department of Physiotherapy MGM Hospital, Kamothe Plot no 1 and 2 Sector 1 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA Raigarh MAHARASHTRA 410209 India
Phone	02227437866
Fax
Email	rmullerpatan@mgmsopnm.edu.in

Details of Contact Person
Public Query

Name	Dr Rajani Mullerpatan
Designation	Professor Director
Affiliation	MGM School of Physiotherapy MGM Institute of Health Sciences
Address	1st Floor room no-115 Out Patient Department Department of Physiotherapy MGM Hospital, Kamothe Plot no 1 and 2 Sector 1 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA Raigarh MAHARASHTRA 410209 India
Phone	02227437866
Fax
Email	rmullerpatan@mgmsopnm.edu.in

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Department of BiotechnologyDBT
Address	6th-8th Floor Block 2 and 4th 5th Floor Block 3 CGO Complex Lodhi Road New Delhi 110003 India
Type of Sponsor	Government funding agency

Details of Secondary Sponsor

Name	Address
MGM School of Physiotherapy MGM Institute of Health Science	MGM School of Physiotherapy MGM Institute of Health Science MGM Educational Campus Plot no 1 and 2 Kamothe Taluka Panvel District Raigad 410209

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Rajani Mullerpatan	MGM Institute of Health Science MGM School of Physiotherapy	Department of Physiotherapy Integrated OPD 1st Floor room no 115 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel Raigarh MAHARASHTRA	02227437866 rmullerpatan@mgmsopnm.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ethical Committee for Research on Human Subjects	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M818\|\|Other osteoporosis without currentpathological fracture,

Intervention / Comparator Agent

Type

Name

Details

Inclusion Criteria

Age From	7.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Healthy children 7 to 15 years Healthy adults elderly individual 40 to 70 years

ExclusionCriteria

Details

Individuals with grade 3 and 4 severe osteoarthritis
low back pain with VAS more than 5 neurological deficit stroke diabetes or hypertension congenital or acquired bony deformities of lower extremities and spine and those having cognitive issues will be excluded

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Cortical sound velocity from newly developed device Bone mineral density measured using DEXA	Baseline

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="1500"
Sample Size from India="1500"
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)

27/09/2025

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="6"
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

The objective of the current mixed method study is :

1.To develop a novel, portable, non-invasive, handheld device to estimate fracture risk by measuring bone mineral density at the radial styloid bone using cortical sound velocity as an outcome measure.

2. To study bone mineral density in-vitro and non-invasive measurement of bone cortical sound velocity in human radius bone

3. To study the reliability and validity of the device in healthy adults.

4. To establish a reference band of waveform (produced based on cortical bone sound velocity) ranging from healthy to osteoporotic bone density for screening people with osteoporosis.

To achieve the above objective the novel device will be first developed with ensuring all safety guidelines and tested in cadaveric bones of different porosity. Then will be pilot tested with novel device and DEXA scan for bone mineral density in 1500 healthy children and adults in the age a group of 7- 15 years and 18 to 70 years. With the study finding association between cortical

bone sound velocity and bone mineral density will be found.