| CTRI Number |
CTRI/2023/10/058456 [Registered on: 09/10/2023] Trial Registered Prospectively |
| Last Modified On: |
17/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison between Percutaneous Vertebroplasty procedure and Teriparatide injection in management of vertebral compression fracture, resulting from bone mineral loss. |
|
Scientific Title of Study
|
A comparative study between fluoroscopy guided percutaneous vertebroplasty and teriparatide injection in treatment of acute and subacute osteoporotic vertebral compression fracture. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishnendu Dey |
| Designation |
MD Postgraduate Trainee |
| Affiliation |
Institue of Postgraduate Medical Education and Research, SSKM Hospital |
| Address |
School of Physical Medicine, Institue of Postgraduate Medical Education and Research, SSKM Hospital, AJC Bose Road, Bhowanipore, Kolkata, West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
8016486657 |
| Fax |
|
| Email |
krishnendu1612@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Pramanik |
| Designation |
Professor and Head of the Department |
| Affiliation |
Institue of Postgraduate Medical Education and Research, SSKM Hospital |
| Address |
School of Physical Medicine, Institue of Postgraduate Medical Education and Research, SSKM Hospital, AJC Bose Road, Bhowanipore, Kolkata, West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9432594882 |
| Fax |
|
| Email |
rpramanik2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Pramanik |
| Designation |
Professor and Head of the Department |
| Affiliation |
Institue of Postgraduate Medical Education and Research, SSKM Hospital |
| Address |
School of Physical Medicine, Institue of Postgraduate Medical Education and Research, SSKM Hospital, AJC Bose Road, Bhowanipore, Kolkata, West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
09432594882 |
| Fax |
|
| Email |
rpramanik2000@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institue of Postgraduate Medical Education and Research, SSKM Hospital |
|
|
Primary Sponsor
|
| Name |
Institue of Postgraduate Medical Education and Research SSKM Hospital |
| Address |
AJC Bose Road, Bhowanipore, Kolkata, West Bengal, PIN 700020 |
| Type of Sponsor |
Government 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 |
| DrKrishnendu Dey |
Institue of Postgraduate Medical Education and Research, SSKM Hospital |
School of Physical Medicine, Institue of Postgraduate Medical Education and Research, SSKM Hospital, AJC Bose Road, Bhowanipore, Kolkata, West Bengal
Kolkata
WEST BENGAL |
8016486657
krishnendu1612@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fluoroscopy Guided Percutaneous Vertebroplasty |
Vertebroplasty is done for osteoporotic vertebral compression fracture, under C-arm Fluoroscopy guidance, in transpedicular approach. Total 2-8 ml volume of PMMA cement is injected. |
| Comparator Agent |
Teriparatide injection |
Teriparatide injection is given at 20mcg per day dose in subcutaneous route, over total 6 months period as a bone forming agent, for pain relief in osteoporotic vertebral compression fracture. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient diagnosed as Osteoporosis as per WHO criteria [T score of
2. Vertebral compression fracture on spine radiograph (minimum height loss 15%).
3. Low back pain for last 6 months or less.
4. Visual analogue scale (VAS) score > 3.
5. Bone edema of vertebral fracture on MRI. |
|
| ExclusionCriteria |
| Details |
1. Spinal instability
2. Radicular pain or Radiculopathy
3. Abnormal coagulation profile
4. Systemic or local infection
5. Severe cardio-pulmonary comorbidities, uncontrolled liver and kidney diseases
6. Uncontrolled Diabetes mellitus
7. Underlying malignant disease
8. Loss of vertebral height ≥80% or vertebra plana, pedicle fracture, burst fracture and Scoliosis
9. Greater than 3 compression fractures
10. Patient’s refusal
11. Allergy to local anesthetic or PMMA, or Teriparatide. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain measured by Visual Analogue Scale |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life measured by using QUALEFFO 41 questionnaire. |
6 month |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" |
Phase of Trial
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
14/10/2023 |
| Date of Study Completion (India) |
30/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Proposed topic of research: A COMPARATIVE STUDY BETWEEN FLUOROSCOPY GUIDED PERCUTANEOUS VERTEBROPLASTY AND TERIPARATIDE INJECTION IN TREATMENT OF ACUTE AND SUBACUTE OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE. Objective of proposed research: To compare the efficacy of vertebroplasty and teriparatide injection in pain relief and improving quality of life in patients with osteoporotic vertebral compression fracture. Research hypothesis: Significant Pain relief in osteoporotic vertebral compression fracture patients following vertebroplasty over teriparatide injection, and immediate relief following procedure. Background of present study: Osteoporotic vertebral compression fractures(OVCFs) are very common in elderly population with osteoporosis all over the world. In India, high prevalence of vertebral fractures can be observed. Lower socio-economic status, inadequate dietary intake, sedentary lifestyles, younger age at puberty, multiparity and early age of menopause in case of females in comparison to other countries and lack of any lifestyle modifications in older persons aggravates osteoporosis and also Osteoporotic Vertebral Compression Fractures (OVCF) among Indian population. At present OVCF is primarily managed conservatively, among which Injection Teriparatide is one the anabolic agents which is used for its bone forming and bone remodeling property. But with conservative treatment many times, responses are inadequate and immediate pain relief is not achieved, as per various literature evidences. Recent advanced procedure for these cases is hereby mentioned in different studies. Percutaneous vertebroplasty is one such procedure used for treatment of pain in these patients, but there is lack of evidences regarding head-to-head comparative study between efficacy of percutaneous vertebroplasty and conservative management for pain relief in OVCF. So, this is our humble approach to compare vertebroplasty and teriparatide injection in treatment of painful osteoporotic vertebral compression fractures. Methodology: • Study design / Experiment design: Parallel group, open label randomized controlled trial • Study duration: 18 months • Place of study: Department of Physical Medicine & Rehabilitation (PM&R), IPGME&R and SSKM Hospital, Kolkata • Study population: Patients attending OPDs of Department of PM&R, IPGME&R, fulfilling inclusion and exclusion criteria. • Sample size: total 38 (19 in each group) |