An interventional study of Raloxifene hydrochloride and Placebo Oral Tablet in Rheumatoid Arthritis, sponsored by Sara Saeidi Shahri. Completed. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-12-16.
Sponsored by Sara Saeidi Shahri · Not applicable, Interventional, and Treatment
The investigators select 40 postmenopausal women suffering from RA with 2.5\<DAS28\<5.5 referring to rheumatology clinics of Mashhad university of medical sciences and randomly divide them into intervention group and placebo group. Evista tab 60mg/day and placebo are administered double blind. In the beginning, total 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 and NSAID should be discontinued 48 hours before every visit. At the end of month 3, disease activity and probable complications 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.
In 4th month, DMARD regimen is administered and then patients are visited every 2 months. Clinical findings are collected in month 0, 1, 2, 3, 6, 8, 10, 12. After 12 months, another total BMD test is carried out and then data are analyzed including changes in BMD, DAS28, EULAR response criteria and HAQ-DI score.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 34 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →This is the only study on the registry with Sara Saeidi Shahri as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
20 postmenopausal women suffering from rheumatoid arthritis that take raloxifene hydrochloride 60 mg oral tablets every day for one year.
Drug: Raloxifene hydrochloride
20 postmenopausal women suffering from rheumatoid arthritis that take placebo pills every day for one year.
Drug: Placebo Oral Tablet
20 patients consume raloxifene hydrochloride oral tablet daily for one year.
Also known as: Evista
20 patients consume placebo oral tablets daily for one year.
Evaluation of DAS-28 criteria
Time frame: 3 months
Assessing of complications
Time frame: 3 months
DAS-28 criteria
Time frame: 12 months
Complications
Time frame: 12 months
EULAR criteria
Time frame: 12 months
HAQ-DI criteria
Time frame: 12 months
Assessing of Bone Marrow Density score
Time frame: 12 months
No study locations are listed for this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.