Effect of raloxifen on serum level of parathyroid hormone on osteoporotic menopausal women with stage 3 to 5 of chronic kidney disease.
Not Applicable
- Conditions
- osteoporosis.Postmenopausal osteoporosis with pathological fracture
- Registration Number
- IRCT201108167343N1
- Lead Sponsor
- Arak University of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 60
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 ?stula 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, ?uoride, bisphosphonates, or calcitonin; withdrawal of raloxifen for more than 4weeks were excluded from the study.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum level of parathyroid hormone. Timepoint: baseline and 6 months after first sampling. Method of measurement: picogram/mililiter and by ELISA method.
- Secondary Outcome Measures
Name Time 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.