| CTRI Number |
CTRI/2025/12/099057 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
14/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
STUDY EFFECT OF ZOLENDRONIC ACID VS DENOSUMAB ON BACK PAIN IN PATIENTS WITH OSTEOPOROSIS IN TERTIARY CARE CENTRE -RANDOMIZED CONTROLLED STUDY |
|
Scientific Title of Study
|
STUDY EFFECT OF ZOLENDRONIC ACID VS DENOSUMAB ON BACK PAIN IN PATIENTS WITH OSTEOPOROSIS IN TERTIARY CARE CENTRE -RANDOMIZED CONTROLLED 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 |
anmol kakkar |
| Designation |
post graduate resident |
| Affiliation |
school of medical sciences and research sharda university |
| Address |
Department of Orthopedics School of Medical Sciences and research Sharda Hospital Sharda University knowledge park 3 greater Noida gautam buddh nagar Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
7876406400 |
| Fax |
|
| Email |
kakkar.anmol89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJNI RANJAN |
| Designation |
PROFESSOR |
| Affiliation |
school of medical sciences and research sharda university |
| Address |
Department of Orthopedics School of Medical Sciences and research Sharda Hospital Sharda University knowledge park 3 greater Noida gautam buddh nagar Gautam Buddha Nagar
Department of Orthopedics School of Medical Sciences and research Sharda Hospital Sharda University knowledge park 3 greater Noida gautam buddh nagar Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9711778515 |
| Fax |
|
| Email |
orthoranjan04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAJNI RANJAN |
| Designation |
PROFESSOR |
| Affiliation |
school of medical sciences and research sharda university |
| Address |
Department of Orthopedics School of Medical Sciences and research Sharda Hospital Sharda University knowledge park 3 greater Noida gautam buddh nagar Gautam Buddha Nagar
Department of Orthopedics School of Medical Sciences and research Sharda Hospital Sharda University knowledge park 3 greater Noida gautam buddh nagar Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9711778515 |
| Fax |
|
| Email |
orthoranjan04@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of orthopaedics , school of medical sciences and research , greater noida , pincode - 201310 |
|
|
Primary Sponsor
|
| Name |
school of medical sciences and research Sharda university |
| Address |
Knowledge park 3, Greater Noida Gautam Buddh Nagar, Uttar Pradesh |
| Type of Sponsor |
Private 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 RAJNI RANJAN |
department of orthopaedics |
school of medical sciences and research sharda university , greater noida , pincode - 201310
Gautam Buddha Nagar
UTTAR PRADESH |
09711778515
orthoranjan04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M818||Other osteoporosis without currentpathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
STUDY EFFECT OF DENOSUMAB ON BACK PAIN, IN PATIENTS WITH OSTEOPOROSIS |
INJ DENOSUMAB |
| Intervention |
STUDY EFFECT OF ZOLENDRONIC ACID ON BACK PAIN, IN PATIENTS WITH OSTEOPOROSIS |
INJ ZOLENDRONIC ACID |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age MORE THAN AND EQUAL TO 50 years
Patient of any gender diagnosed with osteoporosis (T-score LESS THAN -2.5 on DEXA)
Chronic low back pain (MORE THAN 3 months) VAS MORE THAN 4
Pain not relieved by NSAIDs AND opiods and physiotherapy
|
|
| ExclusionCriteria |
| Details |
Prior use of bisphosphonates or denosumab in the last 12 months
History of malignancy and metabolic bone disease (other than osteoporosis)
Patients with traumatic fractures of the spine
Patients on long term glucocorticoid therapy
Any other cause of lower back ache
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the reduction in low back pain intensity (measured using the Visual Analog Scale [VAS]) over a 6-month period between patients receiving zoledronic acid and those receiving denosumab. |
0 , 3 AND 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
01/01/2026 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This randomized controlled trial aims to compare the efficacy of Zoledronic Acid and Denosumab in reducing chronic low back pain among patients with osteoporosis at a tertiary care center. Osteoporosis leads to reduced bone mineral density and chronic pain, especially in postmenopausal women. Both Zoledronic Acid and Denosumab are established anti-resorptive agents but act through different mechanisms. This study will evaluate changes in pain intensity using the Visual Analog Scale (VAS) and bone mineral density (BMD) at the lumbar spine using DEXA scans over six months. Fifty-six patients aged 50 years and above with diagnosed osteoporosis will be randomized into two groups: one receiving Zoledronic Acid 5 mg IV yearly and the other Denosumab 60 mg subcutaneously every six months, along with calcium and vitamin D supplementation. The findings will help determine which agent provides better pain relief and improvement in bone health, aiding clinical decision-making in osteoporosis management. |