| CTRI Number |
CTRI/2024/05/067474 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To Evaluate Disease and Treatment Awareness, Self Medication Practices and
Drugs Prescribed in Patients of Osteoporosis |
|
Scientific Title of Study
|
Evaluation of Disease and Treatment Awareness, Self Medication Practices and
Prescription Patterns in Patients of Osteoporosis Attending a Tertiary Care Hospital: A
Cross-sectional, Questionnaire-based 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 |
Dr Raakhi K Tripathi |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pharmacology & Therapeutics, College building, First Floor, Seth GS
Medical College and KEM Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821724700 |
| Fax |
|
| Email |
lookon@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Urjita Kapadia |
| Designation |
Junior Resident |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pharmacology & Therapeutics, College building, First Floor, Seth GS
Medical College and KEM Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769745159 |
| Fax |
|
| Email |
urjita28@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raakhi K Tripathi |
| Designation |
Associate Professor |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pharmacology & Therapeutics, College building, First Floor, Seth GS
Medical College and KEM Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9821724700 |
| Fax |
|
| Email |
lookon@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Gordhandas Sunderdas Medical College & King Edward Memorial Hospital,
Acharya Donde Marg, Parel, Mumbai, 400012, India. |
|
|
Primary Sponsor
|
| Name |
Dr Raakhi Tripathi |
| Address |
Department of Pharmacology & Therapeutics, College building, First Floor, Seth GS
Medical College & KEM Hospital, Parel, Mumbai 400012. |
| Type of Sponsor |
Other [Associate Professor, PG Guide & Principal investigator] |
|
|
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 Raakhi Tripathi |
Seth GSMC and KEM Hospital Mumbai |
First floor Endocrinology OPD Department of Endocrinology, Orthopaedics OPD Seth GSMC and KEM Hospital Parel Mumbai 400012
Mumbai
MAHARASHTRA |
9821724700
lookon@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) -III Relating to Biomedical and Health Research (BHR), Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
attending Endocrinology OPD and Orthopaedic OPD and have already been receiving treatment for at least 1 month with confirmed diagnosis of Osteoporosis with or without comorbidities by treating physician. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give informed consent
2. Patients admitted in IPD and emergency department
3. Newly diagnosed and treatment naive patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The primary variable is percentage of patients stating yes for each item of the Disease
and Treatment awareness questionnaire.
2. Mean awareness score will be calculated
3. Mean Awareness Score will be correlated with demographic factors (Age, gender,
occupation, education, and socio-economic status as per Kuppuswamy scale). |
As this is a cross-sectional survey, outcomes will be assessed at end of study,i.e, 18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage of patients of Osteoporosis with or without
comorbidities stating yes for each item of the self medication practice questionnaire using descriptive statistics |
As this is a cross-sectional survey, outcomes will be assessed at end of study,i.e, 18 months. |
| To study the pattern of drugs used in the treatment of Osteoporosis . |
As this is a cross-sectional survey, outcomes will be assessed at end of study,i.e, 18 months. |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
27/05/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response (Others) - Data will be shared without revealing identity of participant for publication and presentations.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response (Others) - Questionnaire, Case Record Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [urjita28@hotmail.com].
- For how long will this data be available start date provided 08-05-2024 and end date provided 31-12-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Osteoporosis is a condition characterized by low bone mass and micro-architectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Since the disease is chronic and the course of treatment spans from over 6 months to lifelong, adherence to drug therapy is an important factor to prevent deterioration of the disease. . Adherence to osteoporosis medications is relatively poor. The clinical benefit from osteoporosis therapies has a clear association with medication adherence. Treatment Awareness of the patient will help to improve the adherence of patients to Osteoporosis Medication. There have been no studies in India on Treatment Awareness of Osteoporosis. The study will focus on Assessing Treatment Awareness of Osteoporosis Patients. There have been only a few studies in the Western part of India to evaluate the awareness of Osteoporosis in patients hence, the study also aims to evaluate the Awareness of Osteoporosis in patients of Osteoporosis. Osteoporosis, being a chronic condition, apart from the issue of adherence and poor drug treatment awareness, being a chronic disorder, patient’s resort to self medications. Studies to date suggest that people with chronic conditions are more likely to use CAM (complementary and alternative medicine). Thus, this study will also focus on Self Medication practices in Osteoporosis. The treatment for osteoporosis consists of Non-Pharmacological interventions such as prescribing exercise, weight-bearing physical activity and exercises that improve balance and posture, a diet rich in vitamin D and calcium, quitting smoking, and limiting alcohol use. Specific medication prescriptions are necessary. The Pharmacotherapy of Osteoporosis consists of prescribing drugs which are classified into two groups: those that decrease bone resorption (antiresorptive agents) and those that increase skeletal formation (anabolic agents). Antiresorptive drugs (bisphosphonates [BPs], denosumab, estrogen replacement therapy [ERT], and selective estrogen receptor modulator [SERM]) reduce the rate of bone resorption. Anabolic drugs (teriparatide, romosozumab) stimulate bone formation and partially bone resorption. Since a wide range of treatment options are available for Management of Osteoporosis, hence variability within the prescription pattern is seen. There are very few studies to evaluate prescription pattern. This study aims to evaluate prescription patterns in patients of Osteoporosis. Primary Objective: 1. To evaluate the Disease and Treatment Awareness in patients of Osteoporosis with or without comorbidities coming to Endocrinology OPD and Orthopaedic OPD using a Pre-validated Disease and Treatment Awareness Questionnaire. Secondary Objectives: 1. To assess the Self Medication Practices in Patients of Osteoporosis with or without comorbidities using Pre-validated Self Medication Questionnaire. 2. To evaluate the Prescription Pattern of drugs used in the treatment of patients with Osteoporosis with or without comorbidities. Sample Size: Total of 600 patients attending Endocrinology OPD and Orthopaedic OPD, meeting the inclusion/ exclusion criteria during the study period shall be enrolled. Sample size is in accordance as per WHO guidelines for Good Prescribing Patterns in Health studies. Primary and Secondary Variables shall be measured. Statistical Analysis will be done.
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