| CTRI Number |
CTRI/2019/04/018576 [Registered on: 12/04/2019] Trial Registered Retrospectively |
| Last Modified On: |
10/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How effective is bisphosphonates treatment in the patients with giant cell tumor of bone |
|
Scientific Title of Study
|
Role of Bisphosphonates in the management of Giant cell tumor of bone: A randomized, Comparitive,Clinical, Histopathological and Radiological study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 12-54/13-DC |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddharth Dubey |
| Designation |
junior resident |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Orthopaedics.
All India Institute Of Medical Sciences Ansari Nagar New Delhi.
South
DELHI
110049
India |
| Phone |
|
| Fax |
|
| Email |
siddharthdubey8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shishir Rastogi |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Orthopaedics.
All India Institute Of Medical Sciences Ansari Nagar New Delhi.
South
DELHI
110049
India |
| Phone |
9868397102 |
| Fax |
|
| Email |
drrastogi6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddharth Dubey |
| Designation |
junior resident |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Orthopaedics.
All India Institute Of Medical Sciences Ansari Nagar New Delhi.
DELHI
110049
India |
| Phone |
|
| Fax |
|
| Email |
siddharthdubey8@gmail.com |
|
|
Source of Monetary or Material Support
|
| social servise officer, Department of Orthopaedics All India Institute Of Medical Science New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Orthopaedics All India Institute Of Medical Science New Delhi |
| Address |
Department of Orthopaedics All India Institute Of Medical Science Ansari Nagar New Delhi. |
| 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 Siddharth Dubey |
Department Of Orthopaedics AIIMS New Delhi |
Department Of Orthopaedics AIIMS Ansari Nagar New Delhi
South
DELHI |
9013074787
siddharthdubey8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Comitee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
GIANT CELL TUMOR OF BONE, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
surgery alone |
will be directly subjected to surgery ie curretage and bone grafting |
| Intervention |
Surgery plus bisphosphonate |
15 patients. will recieve 5 mg iv zoledronic acid 3 doses at a interval of 1 month each before definative surgery |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All Patients of both genders and more than 12 years of age with primary and recurrent non-malignant Giant Cell Tumors of bones of extremities
Patients with normal renal functions as measured by standard renal function test
Patients giving informed consent for the study |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1.Patients with malignant and metastatic Giant Cell Tumors of bone
2.Patients not ready to give the consent for study
3.Patients with GCT of the axial skeleton
4.Patients with altered renal functions
5.Patients suffering from thyroid and parathyroid disorders
6.Patients with known allergies to bisphosphonates
7.Children less than 12 years of age
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Apoptosis index using electron microscope at the time of suegery |
3 months i.e. at the time of surgery after completion of bisphosphonate therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
size of swelling
pain by VAS score
sclerosis on X ray
Change in tumor volume on MRI |
3 months i.e. after completion of bisphosphonate therapy |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/04/2014 |
| Date of Study Completion (India) |
15/12/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The trials aiims at evaluating the possible role of bosphonates especially intravenous, in management of giant cell tumor of bone. bisphosphonates is alr eady being used as anti tumor drug in conditions like multiple mueloma, breast cancer. |