Determining the effect of monthly pamidronate intravenous injection in addition to routine treatment in the treatment of children's LCP
Design
This research is a double-blind clinical trial with parallel groups using the random block method and sampling will be done by the available method among LCP patients in two intervention and control groups, and the sample size will be 30 people in each group. Was. The case group will receive pamidronate in addition to routine treatment. The Control group patients will receive routine treatment.
Settings and conduct
This study will be conducted on 60 patients with LCP referred to Mofid Hospital in 1402 and 1403. Patients will be randomly divided into two groups of 30 people. In the case group, pamidronate will be injected monthly and intravenously at 1 mg/kg/dose, and the control group will only receive routine treatment. Both groups will be the same in terms of the type of routine treatment received, the number of visits and other follow-up parameters. Before starting the study, imaging will be done for all patients to assess the condition of the femur bone. Also, this imaging will be repeated six months and one year later. Then, imaging findings, disease grade based on expert opinion and response to treatment will be compared between two groups.
Participants/Inclusion and exclusion criteria
The criteria for entering the study will be patients with LCPD and having consent to participate in the study. Exclusion criteria will be receiving previous treatment and receiving other similar drugs.
Intervention groups
Patients in the control group will receive routine treatment of the underlying disease . In addition to routine treatment, patients in the case group, will also receive pamidronate injections.
Main outcome variables
Disease grade, Response to treatment, Clinical signs, Imaging findings.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230526058299N1
Registration date:2023-07-01, 1402/04/10
Registration timing:registered_while_recruiting
Last update:2023-07-01, 1402/04/10
Update count:0
Registration date
2023-07-01, 1402/04/10
Registrant information
Name
Niloufar Shashaani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7021
Email address
shashaaniniloofar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Monthly Intravenous Pamidronate in the Treatment of Legg Calve Perthes in Children
Public title
The effect of Pamidronate Injection in the Treatment of LCP Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with LCPD
Consent to participate in the study
Exclusion criteria:
Received previous treatments
receiving other similar drugs
Age
To 18 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Among the 60 samples that meet the conditions for entering the study, people will be randomly divided into two groups, case and control, using the random block method. Using a calculator, random numbers from 1 to 60 will be generated, 30 numbers and the first number generated by the calculator will be assigned to the case group and the next 30 numbers will be assigned to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the statistical analyzer, a code will be assigned to the patients of each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Student Blvd., Valenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2023-05-06, 1402/02/16
Ethics committee reference number
IR.SBMU.MSP.REC.1402.042
Health conditions studied
1
Description of health condition studied
Legg-Calve'-Perthes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Disease Grade
Timepoint
Referral time, six months and one year after the intervention
Method of measurement
Imaging findings and physical examination
2
Description
Response to treatment
Timepoint
Referral time, six months and one year after the intervention
Method of measurement
Imaging findings and physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine treatment, the group will receive pamidronate for 6 months. A 90 gram ampoule with a dose of 1 mg/kg will be injected every month. The drug will be prepared from Aburihan company and contains disodium pamidronate.
Category
Treatment - Drugs
2
Description
Control group: A group that will only receive routine treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Children's Hospital Rheumatology Clinic
Full name of responsible person
Reza Shiari
Street address
Mofid Children's Hospital, Shariati Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1551415468
Phone
+98 21 2222 7021
Email
shiareza@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Volenjek Ave., Shahid Beheshti University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloofar Shashaani
Position
Rheumatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Rhematology
Street address
Shariati Ave, Mofid Children's Hospital
City
Tehran
Province
Tehran
Postal code
1551415468
Phone
+98 21 2222 7021
Email
shashaaniniloofar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloofar Shashaani
Position
Rheumatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Rheumatology
Street address
Shariati Ave, Mofid Children's Hospital
City
Tehran
Province
Tehran
Postal code
1551415468
Phone
+98 21 2222 7021
Email
shashaaniniloofar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloofar Shashaani
Position
Rheumatology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Rhematology
Street address
Shariati Ave, Mofid Children's Hospital
City
Tehran
Province
Tehran
Postal code
1551415468
Phone
+98 21 2222 7021
Email
shashaaniniloofar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic information and clinical trial results
When the data will become available and for how long
Access starts one year after results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Research on a related issue
From where data/document is obtainable
Niloofar Shashaani
What processes are involved for a request to access data/document
Communicating with the responsible person by email