A clinical trial on the efficacy of Raloxifene on disease activity and glucocorticoid-induced osteoporosis in postmenopausal women with Rheumatoid Arthritis
We select 40 postmenopausal women suffering from rheumatoid arthritis in order to study efficacy of Raloxifene in disease activity of rheumatoid arthritis in post menopause and randomly divide them into intervention group and placebo group. Patients who fulfill at least 4 criteria of ACR-1987 criteria for rheumatoid arthritis and have DAS28-ESR in range of 2.5-5.5 are included in study, and Patients with thromboembolic events or other rheumatologic disorders are excluded.
Evista tab 60mg/day and placebo are administered double blind. In the beginning, bone mineral density (BMD) assessment is carried out from all patients and then Alendronate is discontinued in 2 groups. In first 3 months, in addition to Evista and placebo, MTX tab 2.5mg is given to patients and they are allowed to consume NSAID with accurate record of its dosage. Patients visit rheumatologist monthly in these 3 months. At the end of month 3, disease activity and probable complications as the main outcome measures are evaluated and compared in 2 groups. Classic regimen should be started for every patient who doesn’t enter remission phase in first 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052022334N1
Registration date:2016-12-27, 1395/10/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-12-27, 1395/10/07
Registrant information
Name
Sara Saeidi Shahri
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3879 5031
Email address
saeidis891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Chancellor of Mashhad University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on the efficacy of Raloxifene on disease activity and glucocorticoid-induced osteoporosis in postmenopausal women with Rheumatoid Arthritis
Public title
clinical trial on the efficacy of Raloxifene on disease activity in Rheumatoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients should be selected from postmenopausal women;Patients should fulfill at least 4 criteria of ACR-1987 for Rheumatoid Arthritis;Patients should have DAS28-ESR in range of 2.5-5.5.
Exclusion criteria: Patients with thromboembolic events;Patients with other rheumatologic disorders;Patients with severe postmenopausal symptoms;Patients with known psychological disorders
Age
From 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
clinicaltrial.gov
Secondary trial Id
NCT02982083
Registration date
2016-12-02, 1395/09/12
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Administration Center(Qoreishi Building), Daneshgah St.
City
Mashhad
Postal code
13944-91388
Approval date
2016-02-02, 1394/11/13
Ethics committee reference number
471905
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Disease activity of rheumatoid arthritis
Timepoint
monthly in first 3 month, every 2 months since 5th month
Method of measurement
based on DAS28-ESR formula
2
Description
Complications of Raloxifene
Timepoint
monthly in first 3 month, every 2 months since 5th month