| CTRI Number |
CTRI/2024/03/064702 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of risk of osteoporotic fractures based on fracture risk assessment tool |
|
Scientific Title of Study
|
Assessment of risk of osteoporotic fractures based on fracture risk assessment tool: A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishank Singh |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of orthopaedics, Rohilkhand medical college and hospital, pilibhit by-pass road,pawan vihar, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7905147415 |
| Fax |
|
| Email |
ishanksingh1712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madan Mohan Nagar |
| Designation |
Professor |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
HOD chamber,Department of orthopaedics, Rohilkhand medical college and hospital, pilibhit by-pass road,pawan vihar, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9837147854 |
| Fax |
|
| Email |
ahanagar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Ishank Singh |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of orthopaedics, Rohilkhand medical college and hospital, pilibhit by-pass road,pawan vihar, Bareilly
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7905147415 |
| Fax |
|
| Email |
ishanksingh1712@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of orthopaedics,Rohilkhand medical college and hospital, pilibhit by-pass road, pawan vihar, Bareilly, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Rohilkhand medical college and hospital |
| Address |
Rohilkhand medical college and hospital, pilibhit by-pass road, pawan vihar, Bareilly |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Ishank Singh |
Rohilkhand medical college and hospital |
Department of orthopaedics,Rohilkhand medical college and hospital, pilibhit by-pass road, pawan vihar
Bareilly
UTTAR PRADESH |
7905147415
ishanksingh1712@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,RMCH, Bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M80-M85||Disorders of bone density and structure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age between 40 to 90 years.
Both genders included
Primary osteoporosis.
Patient willing for study. |
|
| ExclusionCriteria |
| Details |
Patients on anti-resorptive treatment.
Bone metastasis and other secondary osteoporosis patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine risk of osteoporotic fractures based on fracture risk assessment tool with and without BMD. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the values & risk of osteoporotic fractures using fracture risk assessment tool with & without bone mineral density. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
02/04/2024 |
| 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
|
Osteoporosis is a systemic skeletal disorder which is nicknamed "silent thief" due to the asymptomatic nature of the disorder until it causes an osteoporotic facture 7. Osteoporotic fractures are one of the major causes of death in elderly men and women across the world 7. Fragility fractures associated with osteoporosis are common and cause significant costs, morbidity, and mortality 7. Neck of femur fractures are the major cause of morbidity and mortality, although reliable epidemiological data are lacking hospital data suggest that neck of femur fractures are common in India Calcium and vitamin D nutrition plays an important role in determining bone health. Vitamin D Deficiency (VDD) in adults can precipitate or exacerbate osteopenia and osteoporosis and increase the risk of fractures, but question is how to detect and treat such cases and how to predict cases, for treatment or preventive measures, with good and cost-effective manner, especially in the rural population of country like INDIA where patients cannot afford “DEXA SCANS†for economic and availability reasons. The WHO introduced Fracture Risk Assessment Tool (FRAX) in 2008 for use of estimating the 10-year probability of osteoporotic fractures (neck of femur, spine, distal end radius, forearm) in untreated patients with osteopenia. FRAX calculates fracture probability of individuals from age, body mass index and risk factors comprising prior fragility fracture, parental history of neck of femur fracture, current tobacco smoking, Overuse of long term oral glucocorticoids, rheumatoid arthritis, other causes of secondary osteoporosis, and alcohol consumption with information on BMD 7. Therapeutic interventions are recommended if the 10-year risk of fractures is more than 20% for major osteoporotic fractures (MOF) and more than 3% for neck of femur fractures. The aim of my study is to determine if FRAX calculations with BMD and without BMD would produce comparable predictions for the 10 year probability of osteoporotic fractures. Being a silent disease osteoporosis is affecting millions of population and leading to osteoporotic fractures. As there are very few studies done in the western Uttar Pradesh region, this study will be in novel cause and will be beneficial study in prevention and treatment of population in and around this region. |