NIPH Clinical Trials Search

Beneficial effect of Raloxifene on high turn-over bone in chronic hemodialysis patients

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	chronic kidney disease postmenopausal osteoporosis
Date of first enrollment	2009/05/01
Target sample size	50
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	medication of Raloxifene

Outcome(s)

Primary Outcome	serum bone alkaline phosphatase (BAP) level serum bone-specific tartrate-resistant acid phosphatase (TRAP5b) level
Secondary Outcome	serum levels od iPTH, calcium, phosphate, total cholesterol, and triacylglyceride

Key inclusion & exclusion criteria

Age minimum	50years-old
Age maximum	Not applicable
Gender	Female
Include criteria	Postmenopausal hemodialysis patients of 50 years old or over with high serum alkaline phosphatase levels (>= 370 U/L), BAP levels (>= 35.4 U/L), or TRAP-5b levels (>= 4.2 U/L).
Exclude criteria	1. Patients prescribed with bisphosphonate, aluminium, lanthanum, cinacalcet. 2. Patients with venous thrombosis or its history. 3. Immobilised patients in long term. 4. Patients with anti-phospholipid antibody syndrome. 5. Patients in pregnancy (including its possibility) and lactation. 6. Patinets with history of allergy to Raloxifene. 7. Patients with liver dysfunction.