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IRCT201108167343N1 IRCT 2012-08-04 Arak University of Medical Science Effect of raloxifen on serum level of parathyroid hormone on osteoporotic menopausal women with stage 3 to 5 of chronic kidney disease. Effect of raloxifen on serum level of parathyroid hormone on osteoporotic menopausal women with stage 3 to 5 of chronic kidney disease. 2012-06-21 anticipated 60 Complete https://irct.ir/trial/7791 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A osteoporosis. Intervention 1: At the first line in this study we do the bone densitometry in all patients in drug group to determine the severity of osteoporosis and also these laboratory tests as serum creatinine, serum Nitrogen-Urea, calcium, phosphorous and parathyroid hormone and alkaline-phosphates will be done, then reevaluated all these tests and bone densitometry after six months. We will initiate the study after first bone densitometry and laboratory tests. The drug group will take Raloxifen in dosage of 60mg daily. In all patients we prescribe calcium and vitamin D as KDOQI guideline, and monthly all patients will be visited by the researcher and asking them about probable adverse effect of drug, new fracture, and probable leaving the drug. Intervention 2: At the first line in this study we do the bone densitometry in all patients in placebo group to determine the severity of osteoporosis and also these laboratory tests as serum creatinine, serum Nitrogen-Urea, calcium, phosphorous and parathyroid hormone and alkaline-phosphates will be done, then reevaluated all these tests and bone densitometry after six months. We will initiate the study after first bone densitometry and laboratory tests. The placebo group will take a tablet daily, which is the same as Raloxifen. In all patients we prescribe calcium and vitamin D as KDOQI guideline, and monthly all all patients will be visited by the researcher and asking them about probable adverse effect of drug, new fracture, and probable leaving the placebo.

public Tahmineh Farbod Ara

Internal Medicine Department, Amiralmomenin Medical Center, Arak University of Medical Sciences, Basij Square

Arak Iran (Islamic Republic of) 3848176594 +98 86 1417 3630 tfarbodara@gmail.com, Dr.ffarbod@arakmu.ac.ir Arak University of Medical Science scientific Farshid Haghverdi

Internal Medicine Department, Amiralmomenin Medical Center, Arak University of Medical Sciences, Basij Square

Arak Iran (Islamic Republic of) 3848176594 +98 86 1417 3630 Farshid_430@yahoo.com Arak University of Medical Science Iran (Islamic Republic of) Inclusion criteria: longer than 1 year that passed patient`s menopause; patients under treatment in the hemodialysis units or CKD patients with GFR<=60; age older than 35 years. The following exclusion criteria were applied: history of previous HRT; venous occlusive disease; previous history of arteriovenous ﬁstula thrombosis; cardiovascular disease; hepatic disease; cancer; patients had previous evidence of disease, other than chronic renal failure, that could affect bone metabolism; patients who had been recently treated with estrogen, progesterone, tibolone, corticosteroids, anticonvulsants, ﬂuoride, bisphosphonates, or calcitonin; withdrawal of raloxifen for more than 4weeks were excluded from the study. 35 years no limit Female m80.0 Postmenopausal osteoporosis with pathological fracture Treatment - Drugs Placebo At the first line in this study we do the bone densitometry in all patients in drug group to determine the severity of osteoporosis and also these laboratory tests as serum creatinine, serum Nitrogen-Urea, calcium, phosphorous and parathyroid hormone and alkaline-phosphates will be done, then reevaluated all these tests and bone densitometry after six months. We will initiate the study after first bone densitometry and laboratory tests. The drug group will take Raloxifen in dosage of 60mg daily. In all patients we prescribe calcium and vitamin D as KDOQI guideline, and monthly all patients will be visited by the researcher and asking them about probable adverse effect of drug, new fracture, and probable leaving the drug. At the first line in this study we do the bone densitometry in all patients in placebo group to determine the severity of osteoporosis and also these laboratory tests as serum creatinine, serum Nitrogen-Urea, calcium, phosphorous and parathyroid hormone and alkaline-phosphates will be done, then reevaluated all these tests and bone densitometry after six months. We will initiate the study after first bone densitometry and laboratory tests. The placebo group will take a tablet daily, which is the same as Raloxifen. In all patients we prescribe calcium and vitamin D as KDOQI guideline, and monthly all all patients will be visited by the researcher and asking them about probable adverse effect of drug, new fracture, and probable leaving the placebo. Serum level of parathyroid hormone. Timepoint: baseline and 6 months after first sampling. Method of measurement: picogram/mililiter and by ELISA method. Serum calcium. Timepoint: baseline and 6 months after first sampling. Method of measurement: millgram/desiliter and photometery method. Serum phosphorous. Timepoint: baseline nad 6 months after first sampling. Method of measurement: millgram/desiliter and photometery method. Bone densitometery. Timepoint: baseline and 6 months after first sampling. Method of measurement: standard deviation(z-score and t-score) and DEXA method. Fracture incidense. Timepoint: monthly after first sampling. Method of measurement: questionair and observational method. Serum alkaline phosphatase. Timepoint: baseline and 6 months after first sampling. Method of measurement: unit/liter and photometery method. Arak University of Medical Science Approved 2012-02-26 Arak University of Medical Science Arak University of Medical Science, Basij Square Arak Iran (Islamic Republic of)