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CTRI Number  CTRI/2025/12/099176 [Registered on: 16/12/2025] Trial Registered Prospectively
Last Modified On: 15/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Fast vs. Slow Vitamin D Treatment in Osteoporosis Patients 
Scientific Title of Study   The Effectiveness of Rapid correction versus Gradual correction in cases of vitamin D deficient Osteoporotic patients- A Randomized Control Trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S Kavin Balaji 
Designation  Junior Resident 
Affiliation  AIIMS 
Address  room no 31, orthopaedics, OPD block, AIIMS bibinagar, bibinagar mandal, yadadri bhuvanagiri district, Telangana
room no 33, orthopaedics, OPD block, AIIMS bibinagar, bibinagar mandal, yadadri bhuvanagiri district, Telangana
Nalgonda
TELANGANA
508126
India 
Phone  6383270250  
Fax    
Email  balajikavin1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Maheshwar lakkireddy 
Designation  professor and HOD 
Affiliation  AIIMS 
Address  room no 31, orthopaedics, OPD block, AIIMS bibinagar, bibinagar mandal, yadadri bhuvanagiri district, Telangana
room no 33, orthopaedics, OPD block, AIIMS bibinagar, bibinagar mandal, yadadri bhuvanagiri district, Telangana
Nalgonda
TELANGANA
508126
India 
Phone  9440634372  
Fax    
Email  maheshwar.ortho@gmail.com  
 
Details of Contact Person
Public Query  
Name  S Kavin Balaji 
Designation  Junior Resident 
Affiliation  AIIMS 
Address  room no 31, orthopaedics, OPD block, AIIMS bibinagar, bibinagar mandal, yadadri bhuvanagiri district, Telangana
room no 33, orthopaedics, OPD block, AIIMS bibinagar, bibinagar mandal, yadadri bhuvanagiri district, Telangana
Nalgonda
TELANGANA
508126
India 
Phone  6383270250  
Fax    
Email  balajikavin1@gmail.com  
 
Source of Monetary or Material Support  
room no 31, orthopaedics, OPD block, AIIMS bibinagar 
 
Primary Sponsor  
Name  AIIMS 
Address  room no 31, orthopaedics, OPD block, AIIMS bibinagar, bibinagar mandal, yadadri bhuvanagiri district, Telangana, pincode : 508126 
Type of Sponsor  Research institution and hospital 
 
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 S Kavin Balaji  All India Institute Of Medical Science  room no 31, orthopaedics, OPD block, AIIMS bibinagar, bibinagar mandal, yadadri bhuvanagiri
Nalgonda
TELANGANA 		 06383270250

balajikavin1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (AIIMS BBN-IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M80-M85||Disorders of bone density and structure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Daily maintenance dose of vitamin D  Participants in the control group will receive bisphosphonates (Ibandronic acid 150mg once/month), vitamin D routine dose of 2,000IU/day, and elemental calcium (1000mg) for a duration of six months.  
Intervention  High dose vitamin D  The treatment group will receive the same regimen as the control group, along with daily high-dose vitamin D of 60,000IU supplementation for initial 5 days as a corrective measure of hypovitaminosis D and anabolic effect of Vitamin D on bone. 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.All patients who had given consent for the study.
2.Patients of age between more than 50 years with osteoporosis (T score less than -2.5 SD) as determined by DEXA scan.
3.Patients with normal Sr Creatinine, Sr Calcium, Sr Phosphate, Sr Alkaline Phosphatase.
 
 
ExclusionCriteria 
Details  1. Secondary osteoporosis due to utilization of drugs like phenytoin, warfarin, corticosteroids etc and disuse osteoporosis due to deformity or stiffness or patients with endocrinological disorders causing osteoporosis.
2. Patients with abnormally high Sr Parathyroid levels with hypercalcemia ( primary hyperparathyroidism causes - secondary osteoporosis)
3. Subjects with vitamin D level more than 30ng/dL.
4. HIV patients using ART.
5. Patients with active tuberculosis or patients on anti-tubercular treatment.
6. Renal Failure patients on dialysis or post transplantation or patients with high serum creatinine.
7. Subjects with history of nephrolithiasis, urolithiasis.
8. Elderly women using hormone replacement therapy.
9. Elderly men using testosterone inhibitors for BPH.
10. Patients with sarcoidosis or malignancies or chemotherapy.
11. Alcoholic liver disease or any other significant liver disease with elevated enzymes.
12. Malabsorption syndromes.
13. Rheumatological disorders on DMARDs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in T-score on DEXA scan of right hip from baseline to 6 months.
Change in serum 25-hydroxy Vitamin D levels from baseline to 6 months.

Proportion of patients achieving Vitamin D sufficiency at 6 months. 		 Baseline and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   26/12/2025 
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="11"
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
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 25-08-2027 and end date provided 25-06-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   this study evaluates the effectiveness of rapid versus gradual vitamin D correction in osteoporotic patients above 50 years of age with hypovitaminosis D. Osteoporosis is a condition of reduced bone mass and increased fracture risk, commonly diagnosed by DEXA scan. Standard therapy includes bisphosphonates, calcium, and vitamin D supplementation. However, the optimal method of vitamin D correction remains unclear. This randomized controlled trial will include 76 participants divided into two groups. The control group will receive bisphosphonates, 2000 IU/day vitamin D, and calcium, while the treatment group will receive the same regimen plus 60000 IU vitamin D daily for 5 days to achieve rapid correction. Serum vitamin D will be measured at baseline, day 6, and 6 months, while DEXA scans will be repeated at 6 months. Exclusion criteria include secondary osteoporosis, renal failure, endocrine disorders, and malignancy. Data will be analyzed using SPSS with t tests and chi square tests, with significance set at p less than 0.05. The primary outcome is change in DEXA scores between the two groups, while secondary outcomes include correlation between DEXA and vitamin D levels. The study aims to provide evidence on whether rapid correction offers superior bone health benefits compared to gradual correction. 
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