| CTRI Number |
CTRI/2025/08/093537 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing How Atorvastatin and Rosuvastatin Affect Bone Health in People with Type 2 Diabetes |
|
Scientific Title of Study
|
Comparative evaluation of the effect of Atorvastatin and Rosuvastatin on Bone Health Parameters in Patients with Type 2 Diabetes Mellitus on statin therapy: A Cross-Sectional Analytical 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 Shilpa P |
| Designation |
Junior Resident (Academic) |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room No. 905, PG Female hostel,
AIIMS Mangalagiri campus,
AIIMS Mangalagiri,
Guntur District,
Andhra Pradesh - 522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7092511765 |
| Fax |
|
| Email |
shilpaprakashpai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Sharma |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no 323
Department of Pharmacology
AIIMS Mangalagiri,
Guntur District,
Andhra Pradesh - 522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
8551896960 |
| Fax |
|
| Email |
drsushil.pharma@aiimsmangalagiri.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa P |
| Designation |
Junior Resident (Academic) |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of Pharmacology
AIIMS Mangalagiri,
Guntur District,
Andhra Pradesh - 522503
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7092511765 |
| Fax |
|
| Email |
shilpaprakashpai@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Mangalagiri
Guntur District, Andhra Pradesh, India 522503 |
|
|
Primary Sponsor
|
| Name |
AIIMS Mangalagiri |
| Address |
AIIMS, Mangalagiri campus,
Guntur District,
Andhra Pradesh - 522503 |
| 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 Shilpa P |
AIIMS Mangalagiri |
401, Hospital building,
AIIMS Mangalagiri campus,
AIIMS Mangalagiri,
Guntur District,
Andhra Pradesh - 522503
Guntur
ANDHRA PRADESH |
07092511765
shilpaprakashpai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
atorvastatin |
patients who are already on 10-20 mg atorvastatin given per oral OD in the night for 18 months or more as prescribed by the treating physician |
| Comparator Agent |
rosuvastatin |
patients who are already on 5-10 mg rosuvastatin given per oral OD in the night for 18 months or more as prescribed by the treating physician |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participant age must be above 40 years
Previously diagnosed case of type 2 diabetes mellitus
Participants must currently be either on atorvastatin or rosuvastatin for atleast 1.5 yrs (18 months or more)
Participants who have given written informed consent for the study |
|
| ExclusionCriteria |
| Details |
Patients with a known case of any bone-related diseases (e.g., osteoporosis, osteopenia) Patients who are already on any bone-modifying medications (e.g., SGLT-2 Inhibitors, thiazolidinediones, insulin, bisphosphonates, calcium and vitamin D supplementation)
Patient who are having a history of any uncontrolled chronic disorder – renal, liver disease
Post menopausal women
Pregnant and breastfeeding women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help to identify the effects and potential differences between atorvastatin and rosuvastatin on bone health parameters like bone mineral density and bone forming marker - P1NP in patients with type 2 diabetes mellitus. The research will also give an insight on how the duration and doses of the medications create an impact on overall health of the bone. |
Being a cross-sectional study, the outcomes namely BMD and P1NP will be measured once at the time of enrolment in patients who have been taking Atorvastatin or Rosuvastatin for 18 months or more. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
09/09/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Type 2 diabetes mellitus(T2DM) is a chronic metabolic disorder characterized by elevated blood glucose levels due to insulin resistance and insulin deficiency. T2DM significantly increases the risk of cardiovascular disease (CVD), making it a leading cause of morbidity and mortality among individuals with diabetes. Statins, which have been commonly prescribed as a prophylaxis to prevent CVD in diabetic patients, have proven to have pleiotropic effects on bone health. Some studies report increased bone mineral density (BMD) and bone forming markers (P1NP) with statin use, while other studies show no significant effects or even a negative association at higher doses. A study comparing the effects of atorvastatin and rosuvastatin in post menopausal women found significant decrease in P1NP levels after 12 months of rosuvastatin use, whereas the patients on atorvastatin did not exhibit decline in P1NP. This suggests a potential advantage of atorvastatin over rosuvastatin in preserving bone formation activity. While statins are effective in reducing cardiovascular risk, their impact on glycemic control is significant. Higher doses of atorvastatin may cause insulin resistance, while other statins like pravastatin have shown a more favourable glycemic profile. This study will enhance current understanding by providing insights into the effects of atorvastatin and rosuvastatin on bone health in patients with type 2 diabetes mellitus on statin therapy. This research can enhance clinical guidelines and optimize statin selection for patients with T2Dm aiming for comprehensive management of their cardio metabolic and skeletal health. |