Protocol summary
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Study aim
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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)
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Design
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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).
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Evidence of osteonecrosis
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210808052105N1
Registration date:
2022-01-02, 1400/10/12
Registration timing:
prospective
Last update:
2022-01-09, 1400/10/19
Update count:
1
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Registration date
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2022-01-02, 1400/10/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-02-18, 1400/11/29
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Expected recruitment end date
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2024-02-18, 1402/11/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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)
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Public title
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Assess the efficacy of multitarget therapy in prevention of Avascular necrosis (AVN)
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-10-17, 1400/07/25
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Ethics committee reference number
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IR.TUMS.DDRI.REC.1400.036
2
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Ethics committee
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Approval date
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2021-02-27, 1399/12/09
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1399.1204
Health conditions studied
1
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Description of health condition studied
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Osteonecrosis
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Evidence of Osteonecrosis following high-dose Corticosteroids
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Timepoint
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In the first three months after starting Corticosteroid and also one year after starting it
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Method of measurement
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Three-phasic bone scan
Secondary outcomes
1
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Description
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Incidence of side effects of drugs
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Timepoint
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Monthly
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Method of measurement
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History and Laboratory findings
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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Control group: This includes patients who have added 70 mg alendronate weekly to the patient's treatments.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available