A Randomized Controlled Trial (RCT) to assess the efficacy of multitarget therapy in prevention of avascular necrosis (AVN) in patients taking high dose steroid in two groups (case and control)
A Randomized Controlled Trial (RCT) to assess the efficacy of multitarget therapy in prevention of avascular necrosis (AVN) in patients taking high dose steroid in two groups (case and control)
Design
A randomized clinical trial with parallel groups in the third phase in 70 patients with autoimmune connective tissue diseases and vasculitis requiring high-dose corticosteroid therapy (prednisolone or equivalent with doses higher than 30 mg).
Settings and conduct
A total of 70 patients with autoimmune connective tissue diseases and vasculitis who require high doses of steroids are enrolled in Shariati Hospital. After drug intervention, patients are followed for 1 year. Then, in the third and twelfth months, they undergo a triphasic bone scan to determine if there is evidence of concomitant osteonecrosis
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with autoimmune connective tissue diseases and vasculitis; Requires treatment with high doses of corticosteroids
Exclusion criteria:
Co-occurrence of antiphospholipid syndrome; Taking drugs that increase the risk of coagulation, such as oral contraceptives; Occurrence of events leading to increased coagulation such as long-term hospitalization, trauma leading to surgery; Taking anticoagulants; Occurrence of adverse drug reactions in the course of patient assessment.
Intervention groups
The intervention group includes patients in the case group who, in addition to receiving bisphosphate (70 mg weekly), are treated with atorvastatin 40 mg daily, vitamin E (400 mg) daily, and aspirin 80 mg daily.
Main outcome variables
Evidence of osteonecrosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210808052105N1
Registration date:2022-01-02, 1400/10/12
Registration timing:prospective
Last update:2022-01-02, 1400/10/12
Update count:1
Registration date
2022-01-02, 1400/10/12
Registrant information
Name
Seyedeh Tahereh Faezi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0065
Email address
tfaezi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-18, 1400/11/29
Expected recruitment end date
2024-02-18, 1402/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Randomized Controlled Trial (RCT) to assess the efficacy of multitarget therapy in prevention of avascular necrosis (AVN) in patients taking high dose steroid in two groups (case and control)
Public title
Assess the efficacy of multitarget therapy in prevention of Avascular necrosis (AVN)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with autoimmune connective tissue diseases and vasculitis
Requires treatment with high doses of corticosteroids
Exclusion criteria:
Co-occurrence of antiphospholipid syndrome
Taking drugs that increase the risk of coagulation, such as oral contraceptives
Occurrence of events leading to increased coagulation such as long-term hospitalization, trauma leading to surgery
Taking anticoagulants
Occurrence of adverse drug reactions in the course of patient examination
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Balance Blocked Randomization method was used for randomization using Stata software. Random allocation is done using size 4 blocks. The total sample size of 70 patients is estimated, including lost to follow up, about 15% of 10 samples were added to the samples to observe the minimum study capacity based on which the sample size was determined in case of sample loss. Thus, using the ralloc module (Random allocation of treatments in controlled trials) in Stata software, random samples were determined for study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of research and technology, Tehran university of medical sciences
Street address
Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.1204
Health conditions studied
1
Description of health condition studied
Osteonecrosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Evidence of Osteonecrosis following high-dose Corticosteroids
Timepoint
In the first three months after starting Corticosteroid and also one year after starting it
Method of measurement
Three-phasic bone scan
Secondary outcomes
1
Description
Incidence of side effects of drugs
Timepoint
Monthly
Method of measurement
History and Laboratory findings
Intervention groups
1
Description
Intervention group: Includes patients whose multi-target therapies such as atorvastatin 40 mg daily, vitamin E (400 mg) daily, and aspirin 80 mg daily are added to their bisphosphonate (alendronate 70 mg weekly) to prevent osteonecrosis.
Category
Prevention
2
Description
Control group: This includes patients who have added 70 mg alendronate weekly to the patient's treatments.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shariati Hospital
Full name of responsible person
Dr. Seyedeh Tahereh Faezi
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1313514117
Phone
+98 21 8822 0065
Email
tfaezi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Loghman
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Rheumatology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1313514117
Phone
+98 21 8822 0065
Email
loghmanmaryam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyedeh Tahereh Faezi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1313514117
Phone
+98 21 8822 0065
Email
tfaezi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Loghman
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Rheumatology
Street address
Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy
City
Tehran
Province
Tehran
Postal code
1313514117
Phone
+98 21 8822 0065
Email
loghmanmaryam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available