title: Effects of raloxifene on bone metabolism in postmenopausal women on chronic hemodialysis.
abstract: BACKGROUND
  Postmenopausal women with end-stage renal failure are at an increased risk of fracture because of the effects of secondary hyperparathyroidism and postmenopausal osteoporosis. In the present study, we investigated the feasibility of using raloxifene to prevent fractures in postmenopausal women with end-stage renal failure on hemodialysis.
  
  
  METHODS
  This study was conducted using a multicenter, single-arm, prospective design. Raloxifene was administered to postmenopausal women aged ≥50 years who were on maintenance hemodialysis and met any of the following criteria after a 24-week run-in period: an alkaline phosphatase level (bone formation marker) of ≥6.18 µkat/L (≥370 U/L), a bone-specific alkaline phosphatase (BAP; bone formation marker) level of ≥0.59 µkat/L (≥35.4 U/L), or a bone-derived tartrate-resistant acid phosphatase (TRACP-5b; bone resorption marker) level of ≥4.2 U/L.
  
  
  RESULTS
  A total of 48 individuals were eligible for study inclusion. Of them, 30 individuals participated in this study. The BAP levels were significantly decreased at week 4, but returned to the baseline levels at week 24. Similarly, the TRACP-5b levels were significantly decreased at week 4, but returned to the baseline levels at week 24. The serum calcium value decreased consistently after the start of raloxifene therapy. The intact parathyroid hormone (iPTH) levels were likely increased at week 4. The ratio of BAP to iPTH levels and the ratio of TRACP-5b to iPTH levels both showed significant decreases over time. During the raloxifene therapy, no thrombosis or other drug-related adverse events developed.
  
  
  CONCLUSIONS
  The study results indicated that raloxifene can transiently reduce the levels of bone metabolism markers and might be useful for preventing fractures in postmenopausal women with end-stage renal failure, although raloxifene use over the long term may not have adequate efficacy in the absence of appropriate concomitant active vitamin D therapy.
authors.affiliation: Blood Purification Center, Osaka Medical College Hospital, Takatsuki, Japan. katsuyuki@orh.go.jp.|Department of Laboratory Medicine, Osaka Rosai Hospital, 1179-3 Nagasone-cho, Sakai, Osaka, 591-8025, Japan. katsuyuki@orh.go.jp.
authors.forename: Katsuyuki
authors.initials: K
authors.lastname: Nagatoya
authors.affiliation: Nishimoto Clinic, Hirakata, Japan.
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Nishimoto
authors.affiliation: Arisawa General Hospital, Hirakata, Japan.
authors.forename: Nobuhisa
authors.initials: N
authors.lastname: Shibahara
authors.affiliation: Department of Nephrology, Takatsuki General Hospital, Takatsuki, Japan.
authors.forename: Toshikazu
authors.initials: T
authors.lastname: Takahashi
authors.affiliation: Kanehara Clinic, Takatsuki, Japan.
authors.forename: Hironori
authors.initials: H
authors.lastname: Kanehara
authors.affiliation: Sanko Clinic, Ibaraki, Japan.
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Ueno
authors.affiliation: Sanko Fuzoku Clinic, Takatsuki, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Yasuda
authors.affiliation: Okada Clinic, Osaka, Japan.
authors.forename: Shigeki
authors.initials: S
authors.lastname: Okada
authors.affiliation: Kamo Hospital, Kyoto, Japan.
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Ueda
authors.affiliation: Sanko Clinic, Takatsuki, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Hirai
authors.affiliation: Department of Internal Medicine, General Hospital Higashikouri, Hirakata, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Inoue
mesh_terms: D000135:Acid Phosphatase; D000368:Aged; D000469:Alkaline Phosphatase / Q000378:metabolism; D015415:Biomarkers; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001862:Bone Resorption / Q000517:prevention & control*; D001842:Bone and Bones / Q000187:drug effects / Q000378:metabolism*; D005260:Female; D006801:Humans; D007527:Isoenzymes; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control*; D058866:Osteoporotic Fractures / Q000517:prevention & control; D010281:Parathyroid Hormone / Q000097:blood; D017698:Postmenopause / Q000378:metabolism*; D011446:Prospective Studies; D020849:Raloxifene Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D006435:Renal Dialysis; D000071681:Tartrate-Resistant Acid Phosphatase
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D007527:Isoenzymes; D010281:Parathyroid Hormone; D020849:Raloxifene Hydrochloride; D000469:Alkaline Phosphatase; C000605510:ACP5 protein, human; D000135:Acid Phosphatase; D000071681:Tartrate-Resistant Acid Phosphatase
keywords: Bone metabolism; End-stage renal failure; Postmenopausal woman; Raloxifene; Vitamin D