| CTRI Number |
CTRI/2024/01/061240 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating Adherence to Pharmacologic Treatment in Real-world Clinical Practice: A Comprehensive Analysis |
|
Scientific Title of Study
|
Anti osteoporotic treatment :Assessing the adherence to pharmacologic treatment in clinical practice |
| 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 Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
Room No-9 2nd floor Annexe Department Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India
Ahmadabad
GUJARAT
380006
India |
| Phone |
9825019913 |
| Fax |
07926408174 |
| Email |
brd_172@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
Room No-9 2nd floor Annexe Department Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India
GUJARAT
380006
India |
| Phone |
9825019913 |
| Fax |
07926408174 |
| Email |
brd_172@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
Room No-9 2nd floor Annexe Department Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India
GUJARAT
380006
India |
| Phone |
9825019913 |
| Fax |
07926408174 |
| Email |
brd_172@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room no. 9, second floor Annexe Department Research department Stavya Spine Hospital and
Research Institute Ellisbridge,Mithakhali. |
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmedabad 380006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bharat R Dave |
Stavya Spine Hospital & Research Institute |
Room no. 9, second floor Annexe,Department -Research department.Stavya spine hospital and Research Institute,Ellisbridge,Mithakhali Ahmadabad GUJARAT
Ahmadabad
GUJARAT |
9825019913
07926408174
brd_172@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Stavya Spine hospital & Research Institute IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M800||Age-related osteoporosis with current pathological fracture, (2) ICD-10 Condition: M800||Age-related osteoporosis with current pathological fracture, (3) ICD-10 Condition: E88||Other and unspecified metabolic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
DEXA proven osteoporotic patients (T score less than-2.5)
Patients with history of fragility fractures
Patients consenting for participation in the study
|
|
| ExclusionCriteria |
| Details |
Patients not fulfilling inclusion criteria.
Patients not consenting for participation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Adherence rates to the drug regimens prescribed
2.In case of defaulters, reasons for discontinuation of the drug
|
patients will be followed up for a period of 2 years from the point of enrollment in the study.The patients will be scheduled for follow up at 3,6,12,18 and 24 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
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)
|
13/01/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
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 causes over 8.9 million fractures
annually.“Silent Diseases†like osteoporosis pose a challenge in terms of
patient adherence to treatment regimen because the patients do not experience
the benefit of symptom reduction. Personal assessment of the disease status
drives the patient’s motivation for adherence to the medication regimen. Thus
the adherence rates for asymptomatic disease treatments are typically low,
being around 50% at end of 1 year.
Previous studies have claimed that adherence
to prescribed treatment regimens in osteoporosis declined sharply after
diagnosis with persistent falls over subsequent years.Good adherence has
been defined as greater than 80% use of the prescribed medications.The
beneficial effects of medication compliance can be observed with as little as
50% adherence and are even greater with at least 75-80% adherence
We wish to assess the rates of adherence of patients to the prescribed treatment regimens for
anti-osteoporotic drugs and to identify and evaluate the reasons for the
non-adherence to any treatment regimens. |