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CTRI Number  CTRI/2025/03/082694 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 12/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study to see the awareness and knowledge among Indians about weakness of bones 
Scientific Title of Study   To assess knowledge and awareness of osteoporosis and its risk factors among Indian adults: a cross sectional study from a tertiary care teaching 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  Dr Arvind Kumar Sharma 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arvind Kumar Sharma 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arvind Kumar Sharma 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences, Raebareli 
Address  Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  6388930133  
Fax    
Email  arvindkgmu25@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raebareli, Uttar Pradesh 
Address  All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arvind Kumar Sharma  All India Institute of Medical Sciences, Raebareli  Room 22/28, Ground floor, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Madhupuri, Uttar Pradesh 229405
Rae Bareli
UTTAR PRADESH 
6388930133

arvindkgmu25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), AIIMS Raebareli, Uttar Pradesh, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adults aged 40 Years or older visiting the tertiary care hospital 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Questionnaire based data collection  After obtaining consent from the participants willing to take part in the study, demographic details, information regarding socioeconomic status, physical activity and regarding their lifestyle will be collected by means of a questionnaire. This questionnaire has been prepared in English and Hindi so that participants speaking the local vernacular language can understand. The questionnaire includes two scales including Osteoporosis Awareness Knowledge Test and One-Minute Osteoporosis Risk Test. Osteoporosis Awareness Knowledge Test Questionnaire will be utilizing a structured questionnaire to assess participants awareness and knowledge regarding osteoporosis. This may include questions related to risk factors, prevention, and general understanding of the condition. The responses will be compared with a list of the correct answers. A score of 1 will be given for every correct response and 0 will be given for every wrong and unanswered response. The total score will be range from 0 to 20. Results will be compared based on gender and different age groups. One-Minute Osteoporosis Risk Test will include a total of 19 questions out of which 18 risk factors are concerning females and 16 for males. Yes response will be given a score of 1 and No will be scored as 0.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Any individual of 40 years or older without terminal illnesses, willing to participate in the study and providing informed consent. 
 
ExclusionCriteria 
Details  Adults not willing to participate in the study, Individuals with known psychiatric illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Osteoporosis Awareness Knowledge Test score
One-Minute Osteoporosis Risk Test score 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="292"
Sample Size from India="292" 
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)   31/03/2025 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 characterized by diminished bone mass and deterioration of bone tissue structure, leading to increased vulnerability to fractures. This heightened fragility poses a significant health risk, contributing to morbidity and elevated mortality rates. Despite significant progress in diagnosing and treating osteoporosis, a limited number of patients undergo appropriate treatment, even following a fragility fracture.  India has a population exceeding 1.4 billion, with more than 230 million individuals aged 50 and above. Existing data on osteoporosis prevalence among Indian women primarily stem from studies conducted in various regions and smaller populations. Estimates from 2015 indicate that approximately 20% of the 230 million women aged 50 or older in India are affected by osteoporosis. Various studies have reported osteoporosis prevalence among Indian women of different age groups, ranging from 8% to 62%. Osteoporosis prevalence in males aged 50 and above exhibits variability, ranging from 8.5% to 24.6%. Awareness of osteoporosis is limited in India, with surveys indicating that only 10–15% of the population is knowledgeable about the disease. As per the International Osteoporosis Federation, the availability of dual-energy X-ray absorptiometry instruments (DXA), a crucial tool for diagnosing osteoporosis, is approximately 0.26 per million in India—considerably lower than the recommended threshold of 10.6 per million. In addition to osteoporosis often being asymptomatic until a fracture occurs, the need for lifelong and costly treatment poses challenges. In India, mostly among the rural population, female members of the family are dependent on the male members for assistance of their health concerns. Osteoporosis, due to its iceberg phenomena, acts as a silent growing obstacle in the health of the population manifesting in osteoporotic fractures at a very late stage. Awareness of Osteoporosis among the population including the male and female members thereby ensures a better rate of detection and compliance to the treatment prescribed.

The study outcomes will assist in assessment of awareness of osteoporosis among adult population.

Objectives:

-        To assess the awareness level of osteoporosis among adults of ≥ 40 Years.

-        To compare awareness of osteoporosis between male and female population.

-        To assess the risk-factors associated with osteoporosis and its awareness.

Methodology:

Type of study: Our research approach involves a cross-sectional study, where we will gather and analyze quantitative data to address our research objectives.

Duration of Study: Nine Months

Study Population: adults of ≥ 40 Years age visiting the tertiary care hospital.

Inclusion Criteria: Any individual of 40 years or older without terminal illnesses, willing to participate in the study and providing informed consent.

Exclusion Criteria: Adults not willing to participate in the study, Individuals with known psychiatric illness.

Study participants from patients or their attendants coming to the Outpatient Department (OPD). Individuals meeting the inclusion and exclusion criteria will be finally enrolled in the study after providing informed written consent.

Sample size: based on previous study conducted in south India where average osteoporosis awareness score among post-menopausal women was 37.1%, considering it as a base study, sample size was calculated to be 292.

Data Collection:

After obtaining consent from the participants willing to take part in the study, demographic details, information regarding socioeconomic status, physical activity and regarding their lifestyle will be collected by means of a questionnaire. This questionnaire has been prepared in English and Hindi so that participants speaking the local vernacular language can understand. The questionnaire includes two scales including Osteoporosis Awareness Knowledge Test and One-Minute Osteoporosis Risk Test. Osteoporosis Awareness Knowledge Test Questionnaire will be utilizing a structured questionnaire to assess participants awareness and knowledge regarding osteoporosis. This may include questions related to risk factors, prevention, and general understanding of the condition. The responses will be compared with a list of the correct answers. A score of 1 will be given for every correct response and 0 will be given for every wrong and unanswered response. The total score will be range from 0 to 20. Results will be compared based on gender and different age groups. One-Minute Osteoporosis Risk Test will include a total of 19 questions out of which 18 risk factors are concerning females and 16 for males. Yes response will be given a score of 1 and No will be scored as 0.

The collected data will be entered in Microsoft Excel and then will be analyzed and statistically evaluated using SPSS-PC-25 version. Quantitative data will be expressed by mean, standard deviation and difference between comparable groups will be tested by student’s t-test (unpaired) or Mann Whitney ‘U’ test, while qualitative data will be expressed in percentage. Difference between the proportions will be tested by chi square test or Fisher’s exact test. ‘P’ value less than 0.05 would be considered statistically significant.

 

 
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