| 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
|
|
|
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
|
|
|
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. |