ファーマナビゲーター 抗スクレロスチン抗体編

出版社： メディカルレビュー社
著者：
発行日： 2020-08-05
分野： 臨床医学：一般  >  薬物療法
ISBN： 9784779225222
電子書籍版： 2020-08-05 （初版第1刷）
電子書籍
章別単位で購入
ブラウザ、アプリ閲覧

9,020 円(税込)

購入する

商品紹介

基礎・前臨床におけるスクレロスチンの骨作用、ならびに抗スクレロスチン抗体がもたらす骨粗鬆症への影響と最新情報を網羅した一冊。

目次

  • 表紙
  • 序文
  • Contents
  • 執筆者一覧
  • 略語一覧
  • Chapter 1 スクレロスチンの骨作用 : 基礎
  • 1 骨でのWntシグナルとスクレロスチン : Overview
  • 1 Wntシグナル
  • 2 骨におけるWntシグナルと骨疾患
  • 3 骨, 軟骨におけるWnt作用
  • 4 薬剤標的としてのスクレロスチン
  • 2 スクレロスチンと骨芽細胞
  • 1 スクレロスチンとロモソズマブの作用機序
  • 2 骨芽細胞と骨細胞に対するスクレロスチンの効果
  • 3 脂肪細胞分化に対するスクレロスチンの作用
  • 4 抗スクレロスチン抗体による骨形成促進効果の時間的変動
  • 5 抗スクレロスチン抗体の自己制御の分子メカニズム
  • 3 スクレロスチンによる骨吸収の制御
  • 1 古典的Wnt経路による骨吸収抑制作用
  • 2 骨吸収によるスクレロスチンの発現制御
  • 3 抗スクレロスチン抗体による骨吸収抑制作用
  • 4 非古典的Wnt経路による骨吸収制御
  • 4 スクレロスチンと力学的負荷
  • 1 骨に埋め込まれた特殊な細胞, 骨細胞
  • 2 骨細胞におけるスクレロスチン発現の分子メカニズム
  • 3 骨細胞が力学的な環境変化を感知するメカニズム
  • 5 スクレロスチンとホルモン
  • 1 スクレロスチン産生の調節機構
  • 2 骨以外の組織におけるスクレロスチンの作用
  • 3 FGF23とWntシグナリング
  • 6 Wntシグナル・スクレロスチンと骨系統疾患
  • 1 Wntシグナル経路
  • 2 骨系統疾患
  • 1. LRP 5
  • 2. LRP 6
  • 3. LRP 4
  • 4. MESD ( mesoderm development )
  • 5. スクレロスチン
  • 6. SFRP 4
  • 7. WNT 1 ( wingless - type MMTV integration site family 1 )
  • 3 GWAS
  • 1. Estrada K, et al. 2012
  • 2. Moayyeri A, et al. 2014
  • 3. Styrkarsdottir U, et al. 2016
  • 4. Zhou H, et al. 2016
  • 5. Kemp JP, et al. 2017
  • 6. Trajanoska K, et al. 2018
  • 7. Morris JA, et al. 2019
  • Chapter 2 スクレロスチンの骨作用 : 前臨床
  • 1 スクレロスチンの遺伝子改変マウス
  • 1 骨細胞の産生する分子, スクレロスチンの機能
  • 2 骨細胞研究の新たな目標
  • 2 多様な疾患モデル動物に対する抗スクレロスチン抗体の効果
  • 1 骨粗鬆症モデル
  • 2 骨折治癒モデル
  • 3 関節リウマチモデル
  • 4 糖尿病モデル
  • 5 CKD - MBD ( chronic kidney disease - mineral and bone disorder ) モデル
  • 3 骨折治癒過程に対する抗スクレロスチン抗体の作用
  • 1 骨折の治癒過程
  • 1. 一次骨癒合と二次骨癒合
  • 2. 全身の骨リモデリングが骨折修復に及ぼす影響
  • 2 WntシグナルとWnt抑制因子
  • 3 骨形成促進剤が骨折治癒に及ぼす影響
  • 1. PTH製剤
  • 2. 抗スクレロスチン抗体製剤
  • Chapter 3 抗スクレロスチン抗体ロモソズマブと骨粗鬆症
  • 1 ロモソズマブの薬物体内動態
  • 1 血清中濃度推移
  • 1. 健康な閉経後女性
  • 2. 閉経後骨粗鬆症患者
  • 3. 性差
  • 4. 吸収
  • 2 腎機能障害患者
  • 3 ビスホスホネート系薬剤の治療歴がある被験者
  • 4 薬物動態と骨代謝マーカー
  • 5 日本人と非日本人との間の用量 - 反応の類似性
  • 2 骨粗鬆症に対するロモソズマブ, デノスマブの逐次療法 ( FRAME試験 )
  • 1 FRAME試験の各時点における骨折と骨密度に対する影響
  • 1. 12ヵ月時評価 : ロモソズマブ / プラセボ投与12ヵ月
  • 2. 24ヵ月時評価 : ロモソズマブ / プラセボ投与12ヵ月後デノスマブ投与12ヵ月
  • 3. 36ヵ月時評価 : ロモソズマブ / プラセボ投与12ヵ月後デノスマブ投与24ヵ月
  • 2 日本人を対象としたサブ解析
  • 3 安全性
  • 3 骨粗鬆症に対する抗スクレロスチン抗体 - アレンドロネートの逐次療法 ( ARCH試験 )
  • 1 ARCH試験
  • 1. 試験デザイン
  • 2. エントリー基準と患者背景
  • 3. エンドポイント
  • 4. 結果
  • 5. 有害事象
  • 2 スクレロスチンと動脈硬化
  • 3 ビスホスホネートの心血管イベントに対する効果
  • 4 骨粗鬆症に対するロモソズマブとテリパラチドの効果の比較 ( STRUCTURE試験 )
  • 1 対象
  • 2 方法
  • 3 結果
  • 4 考察
  • 5 男性骨粗鬆症に対するロモソズマブの有効性・安全性 ( BRIDGE試験 )
  • 1 男性骨粗鬆症に対するロモソズマブの有効性・安全性
  • 1. 目的
  • 2. 対象
  • 3. 除外基準
  • 4. 主要評価項目
  • 5. 副次的評価項目
  • 6. 探索的評価項目
  • 7. 統計解析法
  • 8. 結果
  • 2 心血管系事象の発現について
  • 6 骨粗鬆症に対するgoal - directed therapyとロモソズマブ
  • 1 goal - directed therapy
  • 2 各種薬物療法による骨密度増加効果
  • 3 ロモソズマブの有用性
  • 7 ロモソズマブ, デノスマブ投与後の逐次治療
  • 1 ロモソズマブ第II相臨床試験の概要
  • 2 ロモソズマブ中止後の骨密度および骨代謝マーカーの変化
  • 3 ロモソズマブ投与後の逐次治療
  • 1. ロモソズマブ→デノスマブ逐次治療
  • 2. ロモソズマブ→アレンドロネート逐次治療
  • 3. ロモソズマブ→ゾレドロネート逐次治療
  • 4 他の骨粗鬆症治療薬投与後のロモソズマブ逐次治療
  • 1. アレンドロネート→ロモソズマブ逐次治療
  • 2. アレンドロネート→ロモソズマブ→デノスマブ逐次治療
  • 3. アレンドロネート→ロモソズマブ→プラセボ逐次治療
  • 5 ロモソズマブの再投与
  • 1. ロモソズマブ→プラセボ→ロモソズマブ逐次治療
  • 2. ロモソズマブ→デノスマブ→ロモソズマブ逐次治療
  • 8 ロモソズマブの安全性と心血管疾患
  • 1 ロモソズマブの大規模臨床試験と心血管系事象報告
  • 2 ビスホスホネートによる血管保護効果
  • 3 骨粗鬆症の重症度と動脈硬化
  • 4 スクレロスチン阻害による心血管系有害事象増加の可能性について
  • 5 市販後調査より推計した心血管系事象の発現率とロモソズマブによる心血管系事象の詳細
  • 和文索引
  • 欧文索引
  • 奥付

この書籍の参考文献

参考文献のリンクは、リンク先の都合等により正しく表示されない場合がありますので、あらかじめご了承下さい。

本参考文献は電子書籍掲載内容を元にしております。

Chapter 1 スクレロスチンの骨作用 : 基礎

P.24 掲載の参考文献
1) Sharma RP. Wingless a new mutant in drosophila melanogaster. Dros Inf Service. 1973 ; 50 : 134.
 
2) Nusse R, Varmus HE. Many tumors induced by the mouse mammary tumor virus contain a provirus integrated in the same region of the host genome. Cell. 1982 ; 31 : 99-109.
PubMed
3) Lerner UH, Ohisson C. The WNT system : background and its role in bone. J Intern Med. 2015 ; 277 : 630-49.
 
4) Kikuchi A, Yamamoto H, Sato A. Selective activation mechanisms of Wnt signaling pathways. Trends Cell Biol. 2009 ; 19 : 119-29.
 
5) Gong Y, Slee RB, Fukai N, et al. LDL receptor-related protein 5 (LRP 5) affects bone accrual and eye development. Cell. 2001 ; 107 : 513-23.
 
6) Little RD, Carulli JP, Del Mastro RG, et al. A mutation in the LDL receptor-related protein 5 gene results in the autosomal dominant high-bone-mass trait. Am H Hum Genet. 2002 ; 70 : 11-9.
 
7) Boyden LM, Mao J, Belsky J, et al. High bone density due to a mutation in LDL-receptor-related protein 5. N Engl J Med. 2002 ; 346 : 1513-21.
PubMed
8) Brunkow ME, Gardner JC, Van Ness J, et al. Bone dysplasia sclerosteosis results from loss of the SOST gene product, a novel cysteine knot-containing protein. Am J Hum Genet. 2001 ; 68 : 577-89.
PubMed
9) Balemans W, Patel N, Ebeling M, et al. Identification of a 52 kb deletion downstream of the SOST gene in patients with van Buchem disease. J Med Genet. 2002 ; 39 : 91-7.
PubMed
10) Li X, Zhang Y, Kang H, et al. Sclerostin binds to LRP 5/6 and antagonizes canonical Wnt signaling. J Bio Chem. 2005 ; 280 : 19883-7.
 
11) Bourhis E, Wang W, Tam C, et al. Wnt antagonists bind through a short peptide to the first β-propeller domain of LRP 5/6. Structue. 2011 ; 19 : 1433-42.
 
12) Baron R, Rawadi G. Targeting the Wnt/beta-catenin pathway to regulate bone formation in the adult skeleton. Endocrinology. 2007 ; 148 : 2635-43.
PubMed
13) Gaur T, Lengner CJ, Hovhannisyan H, et al. Canonical WNT signaling promotes osteogenesis by directly stimulating Runx 2 gene expression. J Biol Chem. 2005 ; 280 : 33132-40.
 
14) Regard JB, Zhong Z, Williams BO, et al. Wnt signaling in bone development and disease : making stronger bone with Wnts. Cold Spring Harb Perspect Biol. 2012 ; 4 : 1-18.
 
15) Day TF, Guo X, Garrett-Beal L, et al. Wnt/beta-catenin signaling in mesenchymal progenitors controls osteoblast and chondrocyte differentiation during vertebrate skeletogenesis. Dev Cell. 2005 ; 8 : 739-50.
PubMed
16) Bennett CN, Longo KA, Wright WS, et al. Regulation of osteoblastogenesis and bone mass by Wnt 10 b. Proc Natl Acad Sci U S A. 2005 ; 102 : 3324-9.
 
17) Glass DA 2 nd, Bialek P, Ahn JD, et al. Canonical Wnt signaling in differentiated osteoblasts controls osteoclast differentiation. Dev Cell. 2005 ; 8 : 751-64.
 
18) Afzal AR, Rajab A, Fenske CD, et al. Recessive Robinow syndrome, allelic to dominant bracydactyly type B, is caused by mutation of ROR 2. Nat Genet 2000 ; 25 : 419-22.
 
19) Maeda K, Kobayashi Y, Udagawa N, et al. Wnt 5 a-Ror 2 signaling between osteoblast-lineage cells and osteoclast precursors enhances osteoclastogenesis. Nat Med. 2012 ; 18 : 405-12.
 
20) Moverare-Skrtic S, Henning P, Liu X, et al. Osteoblast-derived WNT 16 represses osteoclastogenesis and prevents cortical bone fragility. Nat Med. 2014 ; 20 : 1279-88.
 
21) Kim SP, Frey JL, Li Z, et al. Sclerostin influences body composition by regulating catabolic and anabolic metabolism in adipocytes. Proc Natl Acad Sci U S A. 2017 ; 114 : E 11238-47.
 
22) Holdsworth G, Greenslade K, Jose J, et al. Dampening of the bone formation response following repeat dosing with sclerostin antibody in mice is associated with up-regulation of Wnt antagonists. Bone. 2018 ; 107 : 93-103.
PubMed
P.35 掲載の参考文献
1) Veverka V, Henry AJ, Slocombe PM, et al. Characterization of the structural features and interactions of sclerostin : molecular insight into a key regulator of Wnt-mediated bone formation. J Biol Chem. 2009 ; 284 : 10890-900.
PubMed
2) Brunkow ME, Gardner JC, Van Ness J, et al. Bone dysplasia sclerosteosis results from loss of the SOST gene product, a novel cystine knot-containing protein. Am J Hum Genet. 2001 ; 68 : 577-89.
PubMed
3) Holdsworth G, Roberts SJ, Ke HZ. Novel actions of sclerostin on bone. J Mol Endocrinol. 2019 ; 62 : R 167-85.
 
4) Sutherland MK, Geoghegan JC, Yu C, et al. Unique regulation of SOST, the sclerosteosis gene, by BMPs and steroid hormones in human osteoblasts. Bone. 2004 ; 35 : 448-54.
PubMed
5) Winkler DG, Yu C, Geoghegan JC, et al. Noggin and sclerostin bone morphogenetic protein antagonists form a mutually inhibitory complex. J Biol Chem. 2004 ; 279 : 36293-8.
 
6) Winkler DG, Sutherland MS, Ojala E, et al. Sclerostin inhibition of Wnt-3a-induced C 3 H 10 T 1/2 cell differentiation is indirect and mediated by bone morphogenetic proteins. J Biol Chem. 2005 ; 280 : 2498-502.
 
7) Poole KE, van Bezooijen RL, Loveridge N, et al. Sclerostin is a delayed secreted product of osteocytes that inhibits bone formation. Faseb j. 2005 ; 19 : 1842-4.
 
8) van Bezooijen RL, Roelen BA, Visser A, et al. Sclerostin is an osteocyteexpressed negative regulator of bone formation, but not a classical BMP antagonist. J Exp Med. 2004 ; 199 : 805-14.
 
9) Li X, Zhang Y, Kang H, et al. Sclerostin binds to LRP 5/6 and antagonizes canonical Wnt signaling. J Biol Chem. 2005 ; 280 : 19883-7.
 
10) Ellies DL, Viviano B, McCarthy J, et al. Bone density ligand, Sclerostin, directly interacts with LRP 5 but not LRP 5 G 171 V to modulate Wnt activity. J Bone Miner Res. 2006 ; 21 : 1738-49.
 
11) Leupin O, Piters E, Halleux C, et al. Bone overgrowth-associated mutations in the LRP 4 gene impair sclerostin facilitator function. J Biol Chem. 2011 ; 286 : 19489-500.
 
12) Xiong L, Jung JU, Wu H, et al. Lrp 4 in osteoblasts suppresses bone formation and promotes osteoclastogenesis and bone resorption. Proc Natl Acad Sci U S A. 2015 ; 112 : 3487-92.
 
13) Chang MK, Kramer I, Huber T, et al. Disruption of Lrp 4 function by genetic deletion or pharmacological blockade increases bone mass and serum sclerostin levels. Proc Natl Acad Sci U S A. 2014 ; 111 : E 5187-95.
 
14) Ettenberg SA, Charlat O, Daley MP, et al. Inhibition of tumorigenesis driven by different Wnt proteins requires blockade of distinct ligandbinding regions by LRP 6 antibodies. Proc Natl Acad Sci U S A. 2010 ; 107 : 15473-8.
 
15) Patel S, Barkell AM, Gupta D, et al. Structural and functional analysis of Dickkopf 4 (Dkk 4) : New insights into Dkk evolution and regulation of Wnt signaling by Dkk and Kremen proteins. J Biol Chem. 2018 ; 293 : 12149-66.
PubMed
16) Willert K, Brown JD, Danenberg E, et al. Wnt proteins are lipid-modified and can act as stem cell growth factors. Nature. 2003 ; 423 : 448-52.
PubMed
17) Clevers H, Nusse R. Wnt/beta-catenin signaling and disease. Cell. 2012 ; 149 : 1192-205.
PubMed
18) Rawadi G, Vayssiere B, Dunn F, et al. BMP-2 controls alkaline phosphatase expression and osteoblast mineralization by a Wnt autocrine loop. J Bone Miner Res. 2003 ; 18 : 1842-53.
 
19) Kida J, Hata K, Nakamura E, et al. Interaction of LEF 1 with TAZ is necessary for the osteoblastogenic activity of Wnt 3 a. Sci Rep. 2018 ; 8 : 10375.
 
20) Laine CM, Joeng KS, Campeau PM, et al. WNT 1 mutations in early-onset osteoporosis and osteogenesis imperfecta. N Engl J Med. 2013 ; 368 : 1809-16.
 
21) Bennett CN, Longo KA, Wright WS, et al. Regulation of osteoblastogenesis and bone mass by Wnt 10 b. Proc Natl Acad Sci U S A. 2005 ; 102 : 3324-9.
 
22) Zmuda JM, Yerges LM, Kammerer CM, et al. Association analysis of WNT 10 B with bone mass and structure among individuals of African ancestry. J Bone Miner Res. 2009 ; 24 : 437-47.
 
23) Krause C, Korchynskyi O, de Rooij K, et al. Distinct modes of inhibition by sclerostin on bone morphogenetic protein and Wnt signaling pathways. J Biol Chem. 2010 ; 285 : 41614-26.
 
24) Sutherland MK, Geoghegan JC, Yu C, et al. Sclerostin promotes the apoptosis of human osteoblastic cells : a novel regulation of bone formation. Bone. 2004 ; 35 : 828-35.
 
25) Atkins GJ, Rowe PS, Lim HP, et al. Sclerostin is a locally acting regulator of late-osteoblast/preosteocyte differentiation and regulates mineralization through a MEPE-ASARM-dependent mechanism. J Bone Miner Res. 2011 ; 26 : 1425-36.
PubMed
26) Yorgan TA, Peters S, Jeschke A, et al. The Anti-Osteoanabolic Function of Sclerostin Is Blunted in Mice Carrying a High Bone Mass Mutation of Lrp 5. J Bone Miner Res. 2015 ; 30 : 1175-83.
 
27) Li X, Ominsky MS, Niu QT, et al. Targeted deletion of the sclerostin gene in mice results in increased bone formation and bone strength. J Bone Miner Res. 2008 ; 23 : 860-9.
PubMed
28) Lin C, Jiang X, Dai Z, et al. Sclerostin mediates bone response to mechanical unloading through antagonizing Wnt/beta-catenin signaling. J Bone Miner Res. 2009 ; 24 : 1651-61.
PubMed
29) Shahnazari M, Wronski T, Chu V, et al. Early response of bone marrow osteoprogenitors to skeletal unloading and sclerostin antibody. Calcif Tissue Int. 2012 ; 91 : 50-8.
PubMed
30) Taylor S, Ominsky MS, Hu R, et al. Time-dependent cellular and transcriptional changes in the osteoblast lineage associated with sclerostin antibody treatment in ovariectomized rats. Bone. 2016 ; 84 : 148-59.
PubMed
31) Toscani D, Bolzoni M, Ferretti M, et al. Role of Osteocytes in Myeloma Bone Disease : Anti-sclerostin Antibody as New Therapeutic Strategy. Front Immunol. 2018 ; 9 : 2467.
PubMed
32) Ominsky MS, Brown DL, Van G, et al. Differential temporal effects of sclerostin antibody and parathyroid hormone on cancellous and cortical bone and quantitative differences in effects on the osteoblast lineage in young intact rats. Bone. 2015 ; 81 : 380-91.
PubMed
33) Ominsky MS, Niu QT, Li C, et al. Tissue-level mechanisms responsible for the increase in bone formation and bone volume by sclerostin antibody. J Bone Miner Res. 2014 ; 29 : 1424-30.
PubMed
34) Greenbaum A, Chan KY, Dobreva T, et al. Bone CLARITY : Clearing, imaging, and computational analysis of osteoprogenitors within intact bone marrow. Sci Transl Med. 2017 ; 9 : pii : eaah 6518.
 
35) Boyce RW, Brown D, Felx M, et al. Decreased osteoprogenitor proliferation precedes attenuation of cancellous bone formation in ovariectomized rats treated with sclerostin antibody. Bone Rep. 2018 ; 8 : 90-4.
PubMed
36) Fulzele K, Dedic C, Lai F, et al. Loss of Gsalpha in osteocytes leads to osteopenia due to sclerostin induced suppression of osteoblast activity. Bone. 2018 ; 117 : 138-48.
PubMed
37) Kogawa M, Khalid KA, Wijenayaka AR, et al. Recombinant sclerostin antagonizes effects of ex vivo mechanical loading in trabecular bone and increases osteocyte lacunar size. Am J Physiol Cell Physiol. 2018 ; 314 : C53-c61.
PubMed
38) Nishimura R, Hata K, Ikeda F, et al. Signal transduction and transcriptional regulation during mesenchymal cell differentiation. J Bone Miner Metab. 2008 ; 26 : 203-12.
PubMed
39) Nuttall ME, Gimble JM. Controlling the balance between osteoblastogenesis and adipogenesis and the consequent therapeutic implications. Curr Opin Pharmacol. 2004 ; 4 : 290-4.
PubMed
40) Hong JH, Hwang ES, McManus MT, et al. TAZ, a transcriptional modulator of mesenchymal stem cell differentiation. Science. 2005 ; 309 : 1074-8.
 
41) Ukita M, Yamaguchi T, Ohata N, et al. Sclerostin Enhances Adipocyte Differentiation in 3 T 3-L 1 Cells. J Cell Biochem. 2016 ; 117 : 1419-28.
 
42) Fulzele K, Lai F, Dedic C, et al. Osteocyte-Secreted Wnt Signaling Inhibitor Sclerostin Contributes to Beige Adipogenesis in Peripheral Fat Depots. J Bone Miner Res. 2017 ; 32 : 373-84.
PubMed
43) Kim SP, Frey JL, Li Z, et al. Sclerostin influences body composition by regulating catabolic and anabolic metabolism in adipocytes. Proc Natl Acad Sci U S A. 2017 ; 114 : E 11238-47.
 
44) Li S, Huang B, Jiang B, et al. Sclerostin Antibody Mitigates Estrogen Deficiency-Inducted Marrow Lipid Accumulation Assessed by Proton MR Spectroscopy. Front Endocrinol. 2019 ; 10 : 159.
PubMed
45) Costa S, Fairfield H, Reagan MR. Inverse correlation between trabecular bone volume and bone marrow adipose tissue in rats treated with osteoanabolic agents. Bone. 2019 ; 123 : 211-23.
PubMed
46) Nguyen HH, Milat F, Ebeling PR. A new contralateral atypical femoral fracture despite sequential therapy with teriparatide and strontium ranelate. Bone Rep. 2017 ; 6 : 34-7.
PubMed
47) Eastell R, O'Neill TW, Hofbauer LC, et al. Postmenopausal osteoporosis. Nat Rev Dis Primers. 2016 ; 2 : 16069.
 
48) Cummings SR, Eastell R. Risk and Prevention of Fracture in Patients With Major Medical Illnesses : A Mini-Review. J Bone Miner Res. 2016 ; 31 : 2069-72.
PubMed
49) Cheng C, Wentworth K, Shoback DM. New Frontiers in Osteoporosis Therapy. Annu Rev Med. 2019. doi : 10.1146/annurev-med- 052218-020620. [Epub ahead of print]
 
50) Subbiah V, Madsen VS, Raymond AK, et al. Of mice and men : divergent risks of teriparatide-induced osteosarcoma. Osteoporos Int. 2010 ; 21 : 1041-5.
PubMed
51) Ebina K, Hirao M, Hashimoto J, et al. Assessment of the effects of switching oral bisphosphonates to denosumab or daily teriparatide in patients with rheumatoid arthritis. J Bone Miner Metab. 2018 ; 36 : 478-87.
PubMed
52) Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, et al. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions : Results of the FRAME Extension Study. J Bone Miner Res. 2019 ; 34 : 419-28.
PubMed
53) Lim SY, Bolster MB. Profile of romosozumab and its potential in the management of osteoporosis. Drug Des Devel Ther. 2017 ; 11 : 1221-31.
PubMed
54) Ke HZ, Richards WG, Li X, et al. Sclerostin and Dickkopf-1 as therapeutic targets in bone diseases. Endocr Rev. 2012 ; 33 : 747-83.
PubMed
55) Li JY, Walker LD, Tyagi AM, et al. The sclerostin-independent bone anabolic activity of intermittent PTH treatment is mediated by T-cell-produced Wnt 10 b. J Bone Miner Res. 2014 ; 29 : 43-54.
 
56) Boyce RW, Paddock CL, Franks AF, et al. Effects of intermittent hPTH (1-34) alone and in combination with 1, 25 (OH) (2) D (3) or risedronate on endosteal bone remodeling in canine cancellous and cortical bone. J Bone Miner Res. 1996 ; 11 : 600-13.
PubMed
57) Hodsman AB, Kisiel M, Adachi JD, et al. Histomorphometric evidence for increased bone turnover without change in cortical thickness or porosity after 2 years of cyclical hPTH (1-34) therapy in women with severe osteoporosis. Bone. 2000 ; 27 : 311-8.
PubMed
58) McClung MR, Grauer A, Boonen S, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014 ; 370 : 412-20.
PubMed
59) Witte F, Bernatik O, Kirchner K, et al. Negative regulation of Wnt signaling mediated by CK 1-phosphorylated Dishevelled via Ror 2. Faseb j. 2010 ; 24 : 2417-26.
 
60) Nioi P, Taylor S, Hu R, et al. Transcriptional Profiling of Laser Capture Microdissected Subpopulations of the Osteoblast Lineage Provides Insight Into the Early Response to Sclerostin Antibody in Rats. J Bone Miner Res. 2015 ; 30 : 1457-67.
PubMed
61) Gutierrez GM, Kong E, Sabbagh Y, et al. Impaired bone development and increased mesenchymal progenitor cells in calvaria of RB 1 -/- mice. Proc Natl Acad Sci U S A. 2008 ; 105 : 18402-7.
 
62) Calo E, Quintero-Estades JA, Danielian PS, et al. Rb regulates fate choice and lineage commitment in vivo. Nature. 2010 ; 466 : 1110-4.
PubMed
63) Gesty-Palmer D, Yuan L, Martin B, et al. beta-arrestin-selective G protein-coupled receptor agonists engender unique biological efficacy in vivo. Mol Endocrinol. 2013 ; 27 : 296-314.
PubMed
64) Song JL, Nigam P, Tektas SS, et al. microRNA regulation of Wnt signaling pathways in development and disease. Cell Signal. 2015 ; 27 : 1380-91.
PubMed
65) Ishitani T, Kishida S, Hyodo-Miura J, et al. The TAK 1 -NLK mitogen-activated protein kinase cascade functions in the Wnt- 5a/Ca (2+) pathway to antagonize Wnt/beta-catenin signaling. Mol Cell Biol. 2003 ; 23 : 131-9.
 
66) Ishitani T, Ninomiya-Tsuji J, Matsumoto K. Regulation of lymphoid enhancer factor 1/T-cell factor by mitogen-activated protein kinase-related Nemo-like kinase-dependent phosphorylation in Wnt/beta-catenin signaling. Mol Cell Biol. 2003 ; 23 : 1379-89.
PubMed
67) Cain CJ, Rueda R, McLelland B, et al. Absence of sclerostin adversely affects B-cell survival. J Bone Miner Res. 2012 ; 27 : 1451-61.
PubMed
68) Bellido T, Ali AA, Gubrij I, et al. Chronic elevation of parathyroid hormone in mice reduces expression of sclerostin by osteocytes : a novel mechanism for hormonal control of osteoblastogenesis. Endocrinology. 2005 ; 146 : 4577-83.
PubMed
P.48 掲載の参考文献
1) Yamane T, Kunisada T, Tsukamoto H, et al. Wnt signaling regulates hemopoiesis through stromal cells. J Immunol. 2001 ; 167 : 765-72.
PubMed
2) Glass DA 2 nd, Bialek P, Ahn JD, et al. Canonical Wnt signaling in differentiated osteoblasts controls osteoclast differentiation. Dev Cell. 2005 ; 8 : 751-64.
 
3) Holmen SL, Zystra CR, Mukherjee A, et al. Essential role of β-catenin in postnatal bone acquisition. J Biol Chem. 2005 ; 280 : 21162-8.
 
4) Kubota T, Michigami T, Sakaguchi N, et al. LRP 6 hypomorphic mutation affects bone mass through bone resorption in mice and impairs interaction with Mesd. J Bone Miner Res. 2008 ; 23 : 1661-71.
 
5) Nakamura M, Udagawa N, Matsuura S, et al. Osteoprotegerin regulates bone formation through a coupling mechanism with bone resorption. Endocrinology. 2003 ; 144 : 5441-9.
PubMed
6) Koide M, Kobayashi Y, Yamashita T, et al. Bone Formation is coupled to resorption via suppression of sclerostin expression by osteoclasts. J Bone Miner Res. 2017 ; 32 : 2074-86.
PubMed
7) Walker EC, McGregor NE, Poulton IJ, et al. Oncostatin M promotes bone formation independently of resorption when signaling through leukemia inhibitory factor receptor in mice. J Clin Invest. 2010 ; 120 : 582-92.
PubMed
8) Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in postmenopausal women with osteoporosis. N Engl J Med. 2016 ; 375 : 1532-43.
PubMed
9) Li X, Ominsky MS, Niu QT, et al. Targeted deletion of the sclerostin gene in mice results in increased bone formation and bone strength. J Bone Miner Res. 2008 ; 23 : 860-9.
PubMed
10) Kramer I, Loots GG, Studer A, et al. Parathyroid hormone (PTH) -induced bone gain is blunted in SOST overexpressing and deficient mice. J Bone Miner Res. 2010 ; 25 : 178-89.
PubMed
11) Li X, Ominsky MS, Warmington KS, et al. Sclerostin antibody treatment increases bone formation, bone mass, and bone strength in a rat model of postmenopausal osteoporosis. J Bone Miner Res. 2009 ; 24 : 578-88.
 
12) Chavassieux P, Chapurlat R, Portero-Muzy N, et al. Bone-Forming and Antiresorptive Effects of Romosozumab in Postmenopausal Women With Osteoporosis : Bone Histomorphometry and Microcomputed Tomography Analysis After 2 and 12 Months of Treatment. J Bone Miner Res. 2019 ; 34 : 1597-608.
PubMed
13) Maeda K, Kobayashi Y, Udagawa N, et al. Wnt 5 a-Ror 2 signaling between osteoblast-lineage cells and osteoclast precursors enhances osteoclastogenesis. Nat Med. 2012 ; 18 : 405-12.
 
14) Uehara S, Udagawa N, Mukai H, et al. Protein kinase N 3 promotes bone resorption by osteoclasts in response to Wnt 5 a-Ror 2 signaling. Sci Signal. 2017 ; 10 : eaan 0023.
 
15) Kiper POS, Saito H, Gori F, et al. Cortical-Bone Fragility--Insights from sFRP 4 Deficiency in Pyle's Disease. N Engl J Med. 2016 ; 374 : 2553-62.
 
16) Chen K, Ng PY, Chen R, et al. Sfrp 4 repression of the Ror 2/Jnk cascade in osteoclasts protects cortical bone from excessive endosteal resorption. Proc Natl Acad Sci U S A. 2019 ; 116 : 14138-43.
 
P.59 掲載の参考文献
1) Nakashima T, Hayashi M, Takayanagi H. New insights into osteoclastogenic signaling mechanisms.Trends Endocrinol Metab. 2012 ; 23 : 582-90.
PubMed
2) Plotkin LI, Bellido T.Osteocytic signalling pathways as therapeutic targets for bone fragility.Nat Rev Endocrinol. 2016 ; 12 : 593-605.
PubMed
3) Dallas SL, Prideaux M, Bonewald LF.The osteocyte : an endocrine cell ... and more.Endocr Rev. 2013 ; 34 : 658-90.
PubMed
4) Zeng HC, Bae Y, Dawson BC, et al. MicroRNA miR- 23 a cluster promotes osteocyte differentiation by regulating TGF-beta signalling in osteoblasts. Nat Commun. 2017 ; 8 : 15000.
 
5) Baron R, Kneissel M.WNT signaling in bone homeostasis and disease : from human mutations to treatments.Nat Med. 2013 ; 19 : 179-92.
 
6) Ke HZ, Richards WG, Li X, et al. Sclerostin and Dickkopf- 1 as therapeutic targets in bone diseases.Endocr Rev. 2012 ; 33 : 747-83.
PubMed
7) Li X, Ominsky MS, Niu QT, et al. Targeted deletion of the sclerostin gene in mice results in increased bone formation and bone strength. J Bone Miner Res. 2008 ; 23 : 860-9.
PubMed
8) Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 ; 375 : 1532-43.
PubMed
9) Robling AG, Niziolek PJ, Baldridge LA, et al. Mechanical stimulation of bone in vivo reduces osteocyte expression of Sost/sclerostin. J Biol Chem. 2008 ; 283 : 5866-75.
PubMed
10) Amrein K, Amrein S, Drexler C, et al. Sclerostin and its association with physical activity, age, gender, body composition, and bone mineral content in healthy adults. J Clin Endocrinol Metab. 2012 ; 97 : 148-54.
PubMed
11) Armamento-Villareal R, Sadler C, Napoli N, et al. Weight loss in obese older adults increases serum sclerostin and impairs hip geometry but both are prevented by exercise training. J Bone Miner Res. 2012 ; 27 : 1215-21.
PubMed
12) Gaudio A, Pennisi P, Bratengeier C, et al. Increased sclerostin serum levels associated with bone formation and resorption markers in patients with immobilization-induced bone loss. J Clin Endocrinol Metab. 2010 ; 95 : 2248-53.
PubMed
13) Mirza FS, Padhi ID, Raisz LG, et al. Serum sclerostin levels negatively correlate with parathyroid hormone levels and free estrogen index in postmenopausal women. J Clin Endocrinol Metab. 2010 ; 95 : 1991-7.
PubMed
14) Fujita K, Roforth MM, Demaray S, et al. Effects of estrogen on bone mRNA levels of sclerostin and other genes relevant to bone metabolism in postmenopausal women. J Clin Endocrinol Metab. 2014 ; 99 : E 81-8.
 
15) Drake MT, Srinivasan B, Modder UI, et al. Effects of parathyroid hormone treatment on circulating sclerostin levels in postmenopausal women. J Clin Endocrinol Metab. 2010 ; 95 : 5056-62.
PubMed
16) Wein MN, Liang Y, Goransson O, et al. SIKs control osteocyte responses to parathyroid hormone.Nat Commun. 2016 ; 7 : 13176.
PubMed
17) Ardawi MS, Al-Kadi HA, Rouzi AA, et al. Determinants of serum sclerostin in healthy pre- and postmenopausal women. J Bone Miner Res. 2011 ; 26 : 2812-22.
PubMed
18) Szulc P, Boutroy S, Vilayphiou N, et al. Correlates of bone microarchitectural parameters and serum sclerostin levels in men : the STRAMBO study. J Bone Miner Res. 2013 ; 28 : 1760-70.
PubMed
19) Price C, Zhou X, Li W, et al. Real-time measurement of solute transport within the lacunar-canalicular system of mechanically loaded bone : direct evidence for load-induced fluid flow. J Bone Miner Res. 2011 ; 26 : 277-85.
 
20) Uda Y, Azab E, Sun N, et al. Osteocyte Mechanobiology.Curr Osteoporos Rep. 2017 ; 15 : 318-25.
PubMed
21) Wang Y, McNamara LM, Schaffler MB, et al. A model for the role of integrins in flow induced mechanotransduction in osteocytes. Proc Natl Acad Sci U S A. 2007 ; 104 : 15941-6.
 
22) Thi MM, Suadicani SO, Schaffler MB, et al. Mechanosensory responses of osteocytes to physiological forces occur along processes and not cell body and require alpha V beta 3 integrin. Proc Natl Acad Sci U S A. 2013 ; 110 : 21012-7.
PubMed
23) Plotkin LI, Bellido T. Beyond gap junctions : Connexin 43 and bone cell signaling. Bone. 2013 ; 52 : 157-66.
PubMed
24) Yuan X, Serra RA, Yang S.Function and regulation of primary cilia and intraflagellar transport proteins in the skeleton. Ann N Y Acad Sci. 2015 ; 1335 : 78-99.
PubMed
25) Moran MM, McAlexander MA, Biro T, et al. Transient receptor potential channels as therapeutic targets. Nat Rev Drug Discov. 2011 ; 10 : 601-20.
PubMed
26) Rock MJ, Prenen J, Funari VA, et al. Gain-of-function mutations in TRPV 4 cause autosomal dominant brachyolmia. Nat Genet. 2008 ; 40 : 999-1003.
 
27) Lyons JS, Joca HC, Law RA, et al. Microtubules tune mechanotransduction through NOX 2 and TRPV 4 to decrease sclerostin abundance in osteocytes. Sci Signal. 2017 ; 10 : pii : eaan 5748. doi : 10.1126/scisignal.aan5748.
 
28) Mizoguchi F, Mizuno A, Hayata T, et al. Transient receptor potential vanilloid 4 deficiency suppresses unloading-induced bone loss. J Cell Physiol. 2008 ; 216 : 47-53.
PubMed
29) Masuyama R, Vriens J, Voets T, et al. TRPV 4-mediated calcium influx regulates terminal differentiation of osteoclasts. Cell Metab. 2008 ; 8 : 257-65.
 
30) Sasaki F, Hayashi M, Mouri Y, et al. Mechanotransduction via the Piezo 1-Akt pathway underlies Sost suppression in osteocytes. Biochem Biophys Res Commun. 2020 ; 521 : 806-13.
 
31) Murthy SE, Dubin AE, Patapoutian A. Piezos thrive under pressure : mechanically activated ion channels in health and disease. Nat Rev Mol Cell Biol. 2017 ; 18 : 771-83.
PubMed
32) Sun W, Chi S, Li Y, et al. The mechanosensitive Piezo 1 channel is required for bone formation. Elife. 2019 ; 8 : pii : e 47454. doi : 10.7554/eLife.47454.
 
33) Li X, Han L, Nookaew I, et al. Stimulation of Piezo 1 by mechanical signals promotes bone anabolism. 2019 ; 8 : e 49631.
 
34) Florio M, Gunasekaran K, Stolina M, et al. A bispecific antibody targeting sclerostin and DKK- 1 promotes bone mass accrual and fracture repair. Nat Commun. 2016 ; 7 : 11505.
PubMed
P.68 掲載の参考文献
1) Galea GL, Lanyon LE, Price JS. Sclerostin's role in bone's adaptive response to mechanical loading. Bone. 2017 ; 96 : 38-44.
 
2) Gaudio A, Pennisi P, Bratengeier C, et al. Increased sclerostin serum levels associated with bone formation and resorption markers in patients with immolibization-induced bone loss. J Clin Endocrinol Metab. 2010 ; 95 : 2248-53.
PubMed
3) Sebastian A, Loots GG. Transcriptional control of Sost in bone. Bone. 2017 ; 96 : 76-84.
PubMed
4) Collette NM, Genetos DC, Economides AN, et al. Targeted deletion of Sost distal enhancer increases bone formation and bone mass. Proc Natl Acad Sci U S A. 2012 ; 109 : 14092-7.
PubMed
5) Wein MN. Parathyroid hormone signaling in osteocytes. JBMR Plus. 2017 ; 2 : 22-30.
PubMed
6) Drake MT, Srinivasan B, Modder UI, et al. Effects of parathyroid hormone treatment on circulating sclerostin levels in postmenopausal women. J Clin Endocrinol Metab. 2010 ; 95 : 5056-62.
PubMed
7) Mirza FS, Padhi ID, Raisz LG, et al. Serum sclerostin levels negatively correlate with parathyroid hormone levels and free estrogen index in postmenopausal women. J Clin Endocrinol Metab. 2010 ; 95 : 1991-7.
PubMed
8) Drake MT, Khosla S. Hormonal and systemic regulation of sclerostin. Bone. 2017 ; 96 : 8-17.
PubMed
9) Modder UI, Clowes JA, Hoey K, et al. Regulation of circulating sclerostin levels by sex steroids in women and men. J Bone Miner Res. 2011 ; 26 : 27-34.
 
10) Kanbay M, Solak Y, Siriopol D, et al. Sclerostin, cardiovascular disease and mortality : a systematic review and meta-analysis. Int Urol Nephrol. 2016 ; 48 : 2029-42.
PubMed
11) Holdsworth G, Roberts SJ, Ke HZ. Novel actions of sclerostin on bone. J Mol Endocrinol. 2019 ; 62 : R 167-85.
 
12) Evenepoel P, D'Haese P, Brandenburg V. Sclerostin and DKK 1 : new players in renal bone and vascular disease. Kidney Int. 2015 ; 88 : 235-40.
 
13) Ryan ZC, Ketha H, McNulty MS, et al. Sclerostin alters serum vitamin D metabolite and fibroblast growth factor 23 concentrations and the urinary excretion of calcium. Proc Natl Acad Sci U S A. 2013 ; 110 : 6199-204.
PubMed
14) Shimada T, Hasegawa H, Yamazaki Y, et al. FGF-23 is a potent regula- tor of vitamin D metabolism and phosphate homeostasis. J Bone Miner Res. 2004 ; 19 : 429-35.
 
15) Urakawa I, Yamazaki Y, Shimada T, et al. Klotho converts canonical FGF receptor into a specific receptor for FGF 23. Nature. 2006 ; 444 : 770-4.
PubMed
16) Goetz R, Mohammadi M. Exploring mechanisms of FGF signaling through the lens of structural biology. Nat Rev Mol Cell Biol. 2013 ; 14 : 166-80.
PubMed
17) Carrillo-Lopez N, Panizo S, Alonso-Montes C, et al. Direct inhibition of osteoblastic Wnt pathway by fibroblast growth factor 23 contributes to bone loss in chronic kidney disease. Kidney Int. 2016 ; 90 : 77-89.
PubMed
18) Burt PM, Xiao L, Hurley MM. FGF 23 regulates Wnt/β-catenin signaling-mediated osteoarthritis in mice overexpressing high-molecularweight FGF 2. Endocrinology 2018 ; 159 : 2386-96.
 
P.79 掲載の参考文献
1) Wiese KE, Nusse R, van Amerongen R. Wnt signalling : Conquering complexity. Development. 2018 ; 145. pii : dev 165902. doi : 10.1242/dev.165902.
 
2) Baron R, Kneissel M. WNT signaling in bone homeostasis and disease : from human mutations to treatments. Nat Med. 2013 ; 19 : 179-92.
 
3) Kubota T, Michigami T, Ozono K. Wnt signaling in bone metabolism. J Bone Min Metab. 2009 ; 27 : 265-71.
 
4) Mortier GR, Cohn DH, Cormier-Daire V, et al. Nosology and classification of genetic skeletal disorders : 2019 revision. Am J Med Genet Part A. 2019 ; 179 : 2393-419.
PubMed
5) Gong Y, Slee RB, Fukai N, et al. LDL receptor-related protein 5 (LRP 5) affects bone accrual and eye development. Cell. 2001 ; 107 : 513-23.
 
6) Boyden LM, Mao J, Belsky J, et al. High bone density due to a mutation in LDL-receptor-related protein 5. N Engl J Med. 2002 ; 346 : 1513-21.
PubMed
7) Little RD, Carulli JP, Del Mastro RG, et al. A mutation in the LDL receptor-related protein 5 gene results in the autosomal dominant high-bone-mass trait. Am J Hum Genet. 2002 ; 70 : 11-9.
PubMed
8) Mani A, Radhakrishnan J, Wang H, et al. LRP 6 mutation in a family with early coronary disease and metabolic risk factors. Science. 2007 ; 315 : 1278-82.
 
9) Whyte MP, McAlister WH, Zhang F, et al. New explanation for autosomal dominant high bone mass : Mutation of low-density lipoprotein receptor-related protein 6. Bone. 2019 ; 127 : 228-43.
PubMed
10) Leupin O, Piters E, Halleux C, et al. Bone overgrowth-associated mutations in the LRP 4 gene impair sclerostin facilitator function. J Biol Chem. 2011 ; 286 : 19489-500.
 
11) Moosa S, Yamamoto GL, Garbes L, et al. Autosomal-Recessive Mutations in MESD Cause Osteogenesis Imperfecta. Am J Hum Genet. 2019 ; 105 : 836-43.
PubMed
12) Balemans W. Increased bone density in sclerosteosis is due to the deficiency of a novel secreted protein (SOST). Hum Mol Genet. 2001 ; 10 : 537-43.
 
13) Brunkow ME, Gardner JC, Van Ness J, et al. Bone dysplasia sclerosteosis results from loss of the SOST gene product, a novel cystine knotcontaining protein. Am J Hum Genet. 2001 ; 68 : 577-89.
PubMed
14) Balemans W, Patel N, Ebeling M, et al. Identification of a 52 kb deletion downstream of the SOST gene in patients with van Buchem disease. J Med Genet. 2002 ; 39 : 91-7.
PubMed
15) Kim SJ, Bieganski T, Sohn YB, et al. Identification of signal peptide domain SOST mutations in autosomal dominant craniodiaphyseal dysplasia. Hum Genet. 2011 ; 129 : 497-502.
PubMed
16) Simsek Kiper PO, Saito H, Gori F, et al. Cortical-Bone Fragility--Insights from sFRP 4 Deficiency in Pyle's Disease. N Engl J Med. 2016 ; 374 : 2553-62.
 
17) Fahiminiya S, Majewski J, Mort J, et al. Mutations in WNT 1 are a cause of osteogenesis imperfecta. J Med Genet. 2013 ; 50 : 345-8.
 
18) Keupp K, Beleggia F, Kayserili H, et al. Mutations in WNT 1 Cause Different Forms of Bone Fragility. Am J Hum Genet. 2013 ; 92 : 565-74.
 
19) Pyott SM, Tran TT, Leistritz DF, et al. WNT 1 Mutations in Families Affected by Moderately Severe and Progressive Recessive Osteogenesis Imperfecta. Am J Hum Genet. 2013 ; 92 : 590-7.
 
20) Laine CM, Joeng KS, Campeau PM, et al. WNT 1 mutations in early-onset osteoporosis and osteogenesis imperfecta. N Engl J Med. 2013 ; 368 : 1809-16.
 
21) Karasik D, Rivadeneira F, Johnson ML. The genetics of bone mass and susceptibility to bone diseases. Nat Rev Rheumatol. 2016 ; 12 : 323-34.
PubMed
22) Estrada K, Styrkarsdottir U, Evangelou E, et al. Genome-wide metaanalysis identifies 56 bone mineral density loci and reveals 14 loci associated with risk of fracture. Nat Genet. 2012 ; 44 : 491-501.
 
23) Moayyeri A, Hsu YH, Karasik D, et al. Genetic determinants of heel bone properties : Genome-wide association meta-analysis and replication in the GEFOS/GENOMOS consortium. Hum Mol Genet. 2014 ; 23 : 3054-68.
PubMed
24) Styrkarsdottir U, Thorleifsson G, Gudjonsson SA, et al. Sequence variants in the PTCH 1 gene associate with spine bone mineral density and osteoporotic fractures. Nat Commun. 2016 ; 7. doi : 10.1038/ncomms10129.
 
25) Zhou H, Mori S, Ishizaki T, et al. Genetic risk score based on the prevalence of vertebral fracture in Japanese women with osteoporosis. Bone Reports. 2016 ; 5 : 168-72.
PubMed
26) Kemp JP, Morris JA, Medina-Gomez C, et al. Identification of 153 new loci associated with heel bone mineral density and functional involvement of GPC 6 in osteoporosis. Nat Genet. 2017 ; 49 : 1468-75.
 
27) Trajanoska K, Morris JA, Oei L, et al. Assessment of the genetic and clinical determinants of fracture risk : Genome wide association and mendelian randomisation study. BMJ. 2018 ; 362. doi : 10.1136/bmj.k3225.
 
28) Morris JA, Kemp JP, Youlten SE, et al. An atlas of genetic influences on osteoporosis in humans and mice. Nat Genet. 2019 ; 51 : 258-66.
PubMed

Chapter 2 スクレロスチンの骨作用 : 前臨床

P.87 掲載の参考文献
1) Nakashima T, Hayashi M, Takayanagi H. New insights into osteoclastogenic signaling mechanisms. Trends Endocrinol Metab. 2012 ; 23 : 582-90.
PubMed
2) Plotkin LI, Bellido T. Osteocytic signalling pathways as therapeutic targets for bone fragility. Nat Rev Endocrinol. 2016 ; 12 : 593-605.
PubMed
3) Dallas SL, Prideaux M, Bonewald LF. The osteocyte : an endocrine cell … and more. Endocr Rev. 2013 ; 34 : 658-90.
 
4) Baron R, Kneissel M. WNT signaling in bone homeostasis and disease : from human mutations to treatments. Nat Med. 2013 ; 19 : 179-92.
 
5) Ke HZ, Richards WG, Li X, et al. Sclerostin and Dickkopf-1 as therapeutic targets in bone diseases. Endocr Rev. 2012 ; 33 : 747-83.
PubMed
6) Li X, Ominsky MS, Niu QT, et al. Targeted deletion of the sclerostin gene in mice results in increased bone formation and bone strength. J Bone Miner Res. 2008 ; 23 : 860-9.
PubMed
7) Kramer I, Loots GG, Studer A, et al. Parathyroid hormone (PTH) -induced bone gain is blunted in SOST overexpressing and deficient mice. J Bone Miner Res. 2010 ; 25 : 178-89.
PubMed
8) Ryan ZC, Ketha H, McNulty MS, et al. Sclerostin alters serum vitamin D metabolite and fibroblast growth factor 23 concentrations and the urinary excretion of calcium. Proc Natl Acad Sci U S A. 2013 ; 110 : 6199-204.
PubMed
9) Li C, Ominsky MS, Tan HL, et al. Increased callus mass and enhanced strength during fracture healing in mice lacking the sclerostin gene. Bone. 2011 ; 49 : 1178-85.
PubMed
10) McGee-Lawrence ME, Ryan ZC, Carpio LR, et al. Sclerostin deficient mice rapidly heal bone defects by activating beta-catenin and increasing intramembranous ossification. Biochem Biophys Res Commun. 2013 ; 441 : 886-90
 
11) Lim J, Burclaff J, He G, et al. Unintended targeting of Dmp 1-Cre reveals a critical role for Bmpr 1 a signaling in the gastrointestinal mesenchyme of adult mice. Bone Res. 2017 ; 5 : 16049.
 
12) Dallas SL, Xie Y, Shiflett LA, et al. Mouse Cre Models for the Study of Bone Diseases. Curr Osteoporos Rep. 2018 ; 16 : 446-77.
 
13) Weivoda MM, Youssef SJ, Oursler MJ. Sclerostin expression and functions beyond the osteocyte. Bone. 2017 ; 96 : 45-50.
PubMed
14) Maurel DB, Matsumoto T, Vallejo JA, et al. Characterization of a novel murine Sost ER (T 2) Cre model targeting osteocytes. Bone Res. 2019 ; 7 : 6.
 
P.97 掲載の参考文献
1) Winkler DG, Sutherland MK, Geoghegan JC, et al. Osteocyte control of bone formation via sclerostin, a novel BMP antagonist. EMBO J. 2003 ; 22 : 6267-76.
PubMed
2) Li X, Ominsky MS, Niu QT, et al. Targeted deletion of the sclerostin gene in mice results in increased bone formation and bone strength. J Bone Miner Res. 2008 ; 23 : 860-9.
PubMed
3) Li X, Ominsky MS, Warmington KS, et al. Increased bone formation and bone mass induced by sclerostin antibody is not affected by pretreatment or cotreatment with alendronate in osteopenic, ovariectomized rats. Endocrinology. 2011 ; 152 : 3312-22.
 
4) Ominsky MS, Boyd SK, Varela A, et al. Romosozumab Improves Bone Mass and Strength While Maintaining Bone Quality in Ovariectomized Cynomolgus Monkeys. J Bone Miner Res. 2017 ; 32 : 788-801.
PubMed
5) Li X, Warmington KS, Niu QT, et al. Inhibition of sclerostin by monoclonal antibody increases bone formation, bone mass, and bone strength in aged male rats. J Bone Miner Res. 2010 ; 25 : 2647-56.
PubMed
6) Marenzana M, Greenslade K, Eddleston A, et al. Sclerostin antibody treatment enhances bone strength but does not prevent growth retardation in young mice treated with dexamethasone. Arthritis Rheum. 2011 ; 63 : 2385-95.
 
7) Suen PK, He YX, Chow DH, et al. Sclerostin monoclonal antibody enhanced bone fracture healing in an open osteotomy model in rats. J Orthop Res. 2014 ; 32 : 997-1005.
 
8) Cui L, Cheng H, Song C, et al. Time-dependent effects of sclerostin antibody on a mouse fracture healing model. J Musculoskelet Neuronal Interact. 2013 ; 13 : 178-84.
 
9) Morse A, McDonald MM, Schindeler A, et al. Sclerostin Antibody Increases Callus Size and Strength but does not Improve Fracture Union in a Challenged Open Rat Fracture Model. Calcif Tissue Int. 2017 ; 101 : 217-28.
PubMed
10) Kruck B, Zimmermann EA, Damerow S, et al. Sclerostin Neutralizing Antibody Treatment Enhances Bone Formation but Does Not Rescue Mechanically Induced Delayed Healing. J Bone Miner Res. 2018 ; 33 : 1686-97.
 
11) Baron R, Kneissel M. WNT signaling in bone homeostasis and disease : from human mutations to treatments. Nat Med. 2013 ; 19 : 179-92.
 
12) Boyce RW, Brown D, Felx M, et al. Decreased osteoprogenitor proliferation precedes attenuation of cancellous bone formation in ovariectomized rats treated with sclerostin antibody. Bone Rep. 2018 ; 8 : 90-4.
PubMed
13) McInnes IB, Schett G. The pathogenesis of rheumatoid arthritis. N Engl J Med. 2011 ; 365 : 2205-19.
PubMed
14) Chen XX, Baum W, Dwyer D, et al. Sclerostin inhibition reverses systemic, periarticular and local bone loss in arthritis. Ann Rheum Dis. 2013 ; 72 : 1732-6.
PubMed
15) Marenzana M, Vugler A, Moore A, et al. Effect of sclerostin-neutralising antibody on periarticular and systemic bone in a murine model of rheumatoid arthritis : a microCT study. Arthritis Res Ther. 2013 ; 15 : R 125.
 
16) Wehmeyer C, Frank S, Beckmann D, et al. Sclerostin inhibition promotes TNF-dependent inflammatory joint destruction. Sci Transl Med. 2016 ; 8 : 330 ra 335.
 
17) Petit MA, Paudel ML, Taylor BC, et al. Bone mass and strength in older men with type 2 diabetes : the Osteoporotic Fractures in Men Study. J Bone Miner Res. 2010 ; 25 : 285-91.
PubMed
18) Hamann C, Rauner M, Hohna Y, et al. Sclerostin antibody treatment improves bone mass, bone strength, and bone defect regeneration in rats with type 2 diabetes mellitus. J Bone Miner Res. 2013 ; 28 : 627-38.
PubMed
19) Hofbauer LC, Brueck CC, Singh SK, et al. Osteoporosis in patients with diabetes mellitus. J Bone Miner Res. 2007 ; 22 : 1317-28.
PubMed
20) Yee CS, Xie L, Hatsell S, et al. Sclerostin antibody treatment improves fracture outcomes in a Type I diabetic mouse model. Bone. 2016 ; 82 : 122-34.
 
21) Newman CL, Chen NX, Smith E, et al. Compromised vertebral structural and mechanical properties associated with progressive kidney disease and the effects of traditional pharmacological interventions. Bone. 2015 ; 77 : 50-6.
PubMed
22) Costa AG, Bilezikian JP, Lewiecki EM. The potential use of antisclerostin therapy in chronic kidney disease-mineral and bone disorder. Curr Opin Nephrol Hypertens. 2015 ; 24 : 324-9.
PubMed
23) Moe SM, Chen NX, Newman CL, et al. Anti-sclerostin antibody treatment in a rat model of progressive renal osteodystrophy. J Bone Miner Res. 2015 ; 30 : 499-509.
 
P.107 掲載の参考文献
1) SM Perren. Fractures with absolute stability of surgical fixation. In AO Principles of Fracture Management, TP Ruedi ; WM Murphy, Eds. AO Publishing : Davos ; Switzerland : 2001. pp 17-25.
 
2) Einhorn TA. Gerstenfeld LC. Fracture healing : mechanisms and interventions. Nat Rev Rheumatol. 2015 ; 11 : 45-54.
PubMed
3) L Claes. Fractures with flexible surgical fixation. In AO Principles of Fracture Management, TP Ruedi ; WM Murphy, Eds. AO Publishing : Davos : Switzerland ; 2001. pp 11-17.
 
4) Ono T. Takayanagi H. Osteoimmunology in Bone Fracture Healing. Curr Osteoporos Rep. 2017 ; 15 : 367-75.
PubMed
5) Ono T, Okamoto K, Nakashima T, et al. IL- 17 -producing gammadelta T cells enhance bone regeneration. Nat Commun. 2016 ; 7 : 10928.
PubMed
6) Vi L, Baht GS, Whetstone H, et al. Macrophages promote osteoblastic differentiation in-vivo : implications in fracture repair and bone homeostasis. J Bone Miner Res. 2015 ; 30 : 1090-102.
PubMed
7) Vi L, Baht GS, Soderblom EJ, et al. Macrophage cells secrete factors including LRP 1 that orchestrate the rejuvenation of bone repair in mice. Nat Commun. 2018 ; 9 : 5191.
 
8) Weinstein RS. True strength. J Bone Miner Res. 2000 ; 15 : 621-25.
PubMed
9) Maeda K, Takahashi N, Kobayashi Y. Roles of Wnt signals in bone resorption during physiological and pathological states. J Mol Med (Berl). 2013 ; 91 : 15-23.
 
10) Cao Y, Mori S, Mashiba T, et al. Raloxifene, estrogen, and alendronate affect the processes of fracture repair differently in ovariectomized rats. J Bone Miner Res. 2002 ; 17 : 2237-46.
PubMed
11) Li C, Mori S, Li J, et al. Long-term effect of incadronate disodium (YM-175) on fracture healing of femoral shaft in growing rats. J Bone Miner Res. 2001 ; 16 : 429-36.
PubMed
12) Saito M, Shiraishi A, Ito M, et al. Comparison of effects of alfacalcidol and alendronate on mechanical properties and bone collagen cross-links of callus in the fracture repair rat model. Bone. 2010 ; 46 : 1170-9.
PubMed
13) Maeda K, Kobayashi Y, Koide M, et al. The Regulation of Bone Metabolism and Disorders by Wnt Signaling. Int J Mol Sci. 2019 ; 20 : pii : E 5525. doi : 10.3390/ijms20225525.
 
14) Baron R, Kneissel M. WNT signaling in bone homeostasis and disease : from human mutations to treatments. Nat Med 19, 179-192, 2013.
 
15) Colditz J, Thiele S, Baschant U, et al. Postnatal Skeletal Deletion of Dickkopf-1 Increases Bone Formation and Bone Volume in Male and Female Mice, Despite Increased Sclerostin Expression. J Bone Miner Res. 2018 ; 33 : 1698-707.
PubMed
16) Tu X, Delgado-Calle J, Condon KW, et al. Osteocytes mediate the anabolic actions of canonical Wnt/beta-catenin signaling in bone. Proc Natl Acad Sci U S A. 2015 ; 112 : E 478-86.
 
17) Stolina M, Dwyer D, Niu QT, et al. Temporal changes in systemic and local expression of bone turnover markers during six months of sclerostin antibody administration to ovariectomized rats. Bone. 2014 ; 67 : 305-13.
PubMed
18) Taylor S, Hu R, Pacheco E, et al. Differential time-dependent transcriptional changes in the osteoblast lineage in cortical bone associated with sclerostin antibody treatment in ovariectomized rats. Bone Rep. 2018 ; 8 : 95-103.
PubMed
19) van Lierop AH, Moester MJ, Hamdy NA, et al. Serum Dickkopf 1 levels in sclerostin deficiency. J Clin Endocrinol Metab. 2014 ; 99 : E 252-6.
 
20) Witcher PC, Miner SE, Horan DJ, et al. Sclerostin neutralization unleashes the osteoanabolic effects of Dkk 1 inhibition. JCI Insight. 2018 ; 3 : pii : 98673. doi : 10.1172/jci.insight.98673.
 
21) Komatsubara S, Mori S, Mashiba T, et al. Human parathyroid hormone (1-34) accelerates the fracture healing process of woven to lamellar bone replacement and new cortical shell formation in rat femora. Bone. 2005 ; 36 : 678-87.
PubMed
22) Manabe T, Mori S, Mashiba T, et al. Human parathyroid hormone (1-34) accelerates natural fracture healing process in the femoral osteotomy model of cynomolgus monkeys. Bone. 2007 ; 40 : 1475-82.
PubMed
23) Ominsky MS, Brown DL, Van G, et al. Differential temporal effects of sclerostin antibody and parathyroid hormone on cancellous and cortical bone and quantitative differences in effects on the osteoblast lineage in young intact rats. Bone. 2015 ; 81 : 380-91.
PubMed
24) Ominsky MS, Li C, Li X, et al. Inhibition of sclerostin by monoclonal antibody enhances bone healing and improves bone density and strength of nonfractured bones. J Bone Miner Res. 2011 ; 26 : 1012-21.
 
25) Suen PK, He YX, Chow DH, et al. Sclerostin monoclonal antibody enhanced bone fracture healing in an open osteotomy model in rats. J Orthop Res. 2014 ; 32 : 997-1005
 
26) Feng G, Chang-Qing Z, Yi-Min C, et al. Systemic administration of sclerostin monoclonal antibody accelerates fracture healing in the femoral osteotomy model of young rats. Int Immunopharmacol. 2015 ; 24 : 7-13.
PubMed
27) Liu Y, Rui Y, Cheng TY, et al. Effects of Sclerostin Antibody on the Healing of Femoral Fractures in Ovariectomised Rats. Calcif Tissue Int. 2016 ; 98 : 263-74.
PubMed
28) Morse A, McDonald MM, Schindeler A, et al. Sclerostin Antibody Increases Callus Size and Strength but does not Improve Fracture Union in a Challenged Open Rat Fracture Model. Calcif Tissue Int. 2017 ; 101 : 217-28.
PubMed
29) Boyce RW, Brown D, Felx M, et al. Decreased osteoprogenitor proliferation precedes attenuation of cancellous bone formation in ovariectomized rats treated with sclerostin antibody. Bone Rep. 2018 ; 8 : 90-94.
PubMed
30) Florio M, Gunasekaran K, Stolina M, et al. A bispecific antibody targeting sclerostin and DKK-1 promotes bone mass accrual and fracture repair. Nat Commun. 2016 ; 7 : 11505.
PubMed

Chapter 3 抗スクレロスチン抗体ロモソズマブと骨粗鬆症

P.123 掲載の参考文献
1) イベニティ皮下注 105 mg シリンジ申請資料概要
 
P.133 掲載の参考文献
1) McClung MR, Grauer A, Boonen S, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014 ; 370 : 412-20.
PubMed
2) Ishibashi H, Crittenden DB, Miyauchi A, et al. Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis : A phase 2 study. Bone. 2017 ; 103 : 209-15.
PubMed
3) Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 ; 375 : 1532-43.
PubMed
4) Cosman F, Crittenden DB, Ferrari S, et al. FRAME Study : The Foundation Effect of Building Bone With 1 Year of romosozumab leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018 ; 33 : 1219-26.
 
5) Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, et al. One Year of romosozumab followed by Two Years of Denosumab Maintains Fracture Risk Reductions : Results of the FRAME Extension Study. J Bone Miner Res. 2019 ; 34 : 419-28.
PubMed
6) Miyauchi A, Dinavahi RV, Crittenden DB, et al. Increased bone mineral density for 1 year of rosomozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension. Arch Osteoporos. 2019 ; 14 : 59.
PubMed
7) Cosman F, Crittenden DB, Ferrari S, et al. Romosozumab FRAME Study : A post hoc analysis of the role of regional background fracture risk on nonvertebral fracture outcome. J Bone Miner Res. 2018 ; 33 : 1407-16. 7)
 
P.143 掲載の参考文献
1) McClung MR, Grauer A, Boonen S, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014 ; 370 : 412-20.
PubMed
2) Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 ; 375 : 1532-43.
PubMed
3) McClung MR, Brown JP, Diez-Perez A, et al. Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density : A Randomized, Double-Blind, Phase 2, Parallel Group Study. J Bone Miner Res. 2018 ; 33 : 1397-406.
PubMed
4) Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, et al. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions : Results of the FRAME Extension Study. J Bone Miner Res. 2018.
 
5) Cosman F, Crittenden DB, Ferrari S, et al. FRAME Study : The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018 ; 33 : 1219-26.
 
6) Saag KG, Petersen J, Brandi ML, et al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 ; 377 : 1417-27.
PubMed
7) Lewiecki EM, Blicharski T, Goemaere S, et al. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 ; 103 : 3183-93.
 
8) Brunkow ME, Gardner JC, Van Ness J, et al. Bone Dysplasia Sclerosteosis Results from Loss of the SOST Gene Product, a Novel Cystine Knot-Containing Protein. The American Journal of Human Genetics. 2001 ; 68 : 577-89.
PubMed
9) Wang XR, Yuan L, Zhang JJ, et al. Serum sclerostin values are associated with abdominal aortic calcification and predict cardiovascular events in patients with chronic kidney disease stages 3-5 D. Nephrology (Carlton). 2017 ; 22 : 286-92.
 
10) Hampson G, Edwards S, Conroy S, et al. The relationship between inhibitors of the Wnt signalling pathway (Dickkopf- 1 (DKK 1) and sclerostin), bone mineral density, vascular calcification and arterial stiffness in postmenopausal women. Bone. 2013 ; 56 : 42-7.
 
11) Claes KJ, Viaene L, Heye S, et al. Sclerostin : Another vascular calcification inhibitor? J Clin Endocrinol Metab. 2013 ; 98 : 3221-8.
PubMed
12) Zhu D, Mackenzie NC, Millan JL, et al. The appearance and modulation of osteocyte marker expression during calcification of vascular smooth muscle cells. PLoS One. 2011 ; 6 : e 19595.
 
13) Kanbay M, Solak Y, Siriopol D, et al. Sclerostin, cardiovascular disease and mortality : a systematic review and meta-analysis. Int Urol Nephrol. 2016 ; 48 : 2029-42.
PubMed
14) Okamoto M, Yamanaka S, Yoshimoto W, et al. Alendronate as an Effective Treatment for Bone Loss and Vascular Calcification in Kidney Transplant Recipients. Journal of Transplantation. 2014 ; 2014 : 1-6.
PubMed
15) Kang JH, Keller JJ, Lin HC. Bisphosphonates reduced the risk of acute myocardial infarction : a 2 -year follow-up study. Osteoporos Int. 2013 ; 24 : 271-7.
PubMed
16) Elmariah S, Delaney JAC, O'Brien KD, et al. Bisphosphonate Use and Prevalence of Valvular and Vascular Calcification in Women. Journal of the American College of Cardiology. 2010 ; 56 : 1752-9.
 
17) Zhou S, Fang X, Xin H, et al. Effects of alendronate on the Notch 1 RBPJkappa signaling pathway in the osteogenic differentiation and mineralization of vascular smooth muscle cells. Mol Med Rep. 2013 ; 8 : 89-94.
 
18) Caffarelli C, Montagnani A, Nuti R, et al. Bisphosphonates, atherosclerosis and vascular calcification : update and systematic review of clinical studies. Clin Interv Aging. 2017 ; 12 : 1819-28.
PubMed
19) Kranenburg G, Bartstra JW, Weijmans M, et al. Bisphosphonates for cardiovascular risk reduction : A systematic review and meta-analysis. Atherosclerosis. 2016 ; 252 : 106-15.
PubMed
20) Kim DH, Rogers JR, Fulchino LA, et al. Bisphosphonates and risk of cardiovascular events : a meta-analysis. PLoS One. 2015 ; 10 : e 0122646.
 
21) Sing CW, Wong AY, Kiel DP, et al. Association of Alendronate and Risk of Cardiovascular Events in Patients With Hip Fracture. J Bone Miner Res. 2018 ; 33 : 1422-34.
PubMed
P.155 掲載の参考文献
1) Langdahl BL, Libanati C, Crittenden DB, et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy : a randomised, open-label, phase 3 trial. Lancet. 2017 ; 390 : 1585-94.
PubMed
2) Keaveny TM, Crittenden DB, Bolognese MA, et al. Greater Gains in Spine and Hip Strength for Romosozumab Compared With Teriparatide in Postmenopausal Women With Low Bone Mass. J Bone Miner Res. 2017 ; 3 : 1956-62.
PubMed
3) Silverman S, Langdahl BL, Fujiwara S, et al. Reduction of Hip and Other Fractures in Patients Receiving Teriparatide in Real-World Clinical Practice : Integrated Analysis of Four Prospective Observational Studies. Calcif Tissue Int. 2019 ; 104 : 193-200.
PubMed
P.166 掲載の参考文献
1) Orimo H, Yaegashi Y, Hosoi T, et al. Hip fracture incidence in Japan : Estimates of new patients in 2012 and 25-year trends. Osteoporos Int. 2016 ; 27 : 1777-84.
PubMed
2) Watts NB, Adler RA, Bilezikian JP, et al. Osteoporosis in men : an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2012 ; 97 : 1802-22.
PubMed
3) 森聖二郎. 男性骨粗鬆症. 基礎老化研究. 2010 ; 34 : 13-7.
Medical*Online
4) Khosla S, Melton LJ 3 rd, Atkinson EJ, et al. Relationship of serum steroid levels to lomgitudinal changes in bone density in young versus elderly men. J Clin Endocrinol Metab. 2001 ; 86 : 3555-61.
 
5) 山内美香, 杉本利嗣. 男性骨粗鬆症の臨床的特性. Clin Calcium. 2016 ; 26 : 973-9.
 
6) Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 ; 375 : 1532-43.
PubMed
7) Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, et al. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture RiskReductions : Results of the FRAME Extension Study. J Bone Miner Res. 2019 ; 34 : 419-28.
PubMed
8) Miyauchi A, Dinavahi RV, Crittenden DB, et al. Increased bone mineral density for 1 year of romosozumab, vs placebo, followed by 2 years of denosumab in the Japanese subgroup of the pivotal FRAME trial and extension. Arch Osteoporos. 2019 ; 14 : 59.
PubMed
9) Lewiecki EM, Blicharski T, Goemaere S, et al. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 ; 103 : 3183-93.
 
10) Saag KG, Petersen J, Brandi ML, et al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 ; 377 : 1417-27.
PubMed
11) 宮内章光. 薬物療法 新規薬剤 抗スクレロスチン抗体. 稲葉雅章 (編). 骨粗鬆症診療. 東京 : 医薬ジャーナル社 ; 2018. p. 200-5.
 
12) 宮内章光. 新しい骨粗鬆症治療薬抗スクレロスチン抗体Romosozumabの有効性と安全性. 内分泌糖尿代謝内科. 2019 ; 49 : 138-45.
 
13) Miyauchi A, Matsumoto T, Sugimoto T, et al. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study : 12-Months, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 ; 47 : 493-502.
 
14) 宮内章光. 薬物治療 テリパラチド. 日臨. 2013 ; : 308-26.
Medical*Online
15) Niimi R, Kono T, Nishihara A, et al. Analysis of daily teriparatide treatment for osteoporosis in men. Osteoporos Int. 2015 ; 26 : 1303-9.
PubMed
P.175 掲載の参考文献
1) 宗圓聰. 骨粗鬆症の薬物治療-治療率と治療継続率についての検証-. Ther Res. 2013 ; 34 : 391-7.
Medical*Online
2) Cummings SR, Cosman F, Lewiecki EM, et al. Goal-Directed Treatment for Osteoporosis : A Progress Report From the ASBMR-NOF Working Group on Goal-Directed Treatment for Osteoporosis. J Bone Miner Res. 2017 ; 32 : 3-10.
 
3) Bouxsein ML, Eastell R, Lui Y, et al. Change in Bone Density and Reduction in Fracture Risk : A Meta-Regression of Published Trials. J Bone Miner Res. 2019 ; 34 : 632-42.
 
4) Mandema JW, Zheng J, Libanati C, et al. Time course of bone mineral density changes with denosumab compared with other drugs in postmenopausal osteoporosis : a dose-response-based meta-analysis. J Clin Endocrinol Metab. 2014 ; 99 : 3746-55.
PubMed
5) Tsai JN, Uihlein AV, Lee H, et al. Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis : the DATA study randomised trial. Lancet. 2013 ; 382 : 50-6.
 
6) McClung MR, Grauer A, Boonen S, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014 ; 370 : 412-20.
PubMed
7) McClung MR. Romosozumab for the treatment of osteoporosis. Osteoporos Sarcopenia. 2018 ; 4 : 11-5.
PubMed
8) Cosman F, Crittenden DB, Ferrari S, et al. FRAME Study : The Foundation Effect of Building Bone With 1 Year of Romosozumab Leads to Continued Lower Fracture Risk After Transition to Denosumab. J Bone Miner Res. 2018 ; 33 : 1219-26.
 
9) Ferrari S, Libanati C, Lin CJF, et al. Relationship Between Bone Mineral Density T-Score and Nonvertebral Fracture Risk Over 10 Years of Denosumab Treatment. J Bone Miner Res. 2019 ; 34 : 1033-40.
PubMed
10) Cummings SR, San Martin J, McClung MR, et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med. 2009 ; 361 : 756-65.
PubMed
P.187 掲載の参考文献
1) McClung MR, Brown JP, Diez-Perez A, et al. Effects of 24 Months of Treatment With Romosozumab Followed by 12 Months of Denosumab or Placebo in Postmenopausal Women With Low Bone Mineral Density : A Randomized, Double-Blind, Phase 2, Parallel Group Study. J Bone Miner Res. 2018 ; 33 : 1397-406.
PubMed
2) McClung MR, Grauer A, Boonen S, et al. Romosozumab in postmenopausal women with low bone mineral density. N Engl J Med. 2014 ; 370 : 412-20.
PubMed
3) Kendler DL, Bone HG, Massari F, et al. Bone mineral density gains with a second 12 -month course of romosozumab therapy following placebo or denosumab. Osteoporos Int. 2019. Osteoporos Int. 2019 ; 30 : 2437-48
PubMed
4) Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab Treatment in Postmenopausal Women with Osteoporosis. N Engl J Med. 2016 ; 375 : 1532-43.
PubMed
5) Lewiecki EM, Dinavahi RV, Lazaretti-Castro M, et al. One Year of Romosozumab Followed by Two Years of Denosumab Maintains Fracture Risk Reductions : Results of the FRAME Extension Study. J Bone Miner Res. 2019 ; 34 : 419-28.
PubMed
6) Saag KG, Petersen J, Brandi ML, et al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 ; 377 : 1417-27.
PubMed
7) McClung MR, Bolognese MA, Brown JP, et al. Transition to zoledronic acid after romosozumab treatment maintains bone mineral density gains. ENDO Annual Meeting. 2017 : OR 08-2.
 
8) Langdahl BL, Libanati C, Crittenden DB, et al. Romosozumab (sclerostin monoclonal antibody) versus teriparatide in postmenopausal women with osteoporosis transitioning from oral bisphosphonate therapy : a randomised, open-label, phase 3 trial. Lancet. 2017 ; 390 : 1585-94.
PubMed
9) Bone HG, Bolognese MA, Yuen CK, et al. Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass. J Clin Endocrinol Metab. 2011 ; 96 : 972-80.
 
10) Chapurlat R. Effects and management of denosumab discontinuation. Joint Bone Spine. 2018 ; 85 : 515-7.
PubMed
11) Freemantle N, Satram-Hoang S, Tang ET, et al. Final results of the DAPS (Denosumab Adherence Preference Satisfaction) study : a 24 -month, randomized, crossover comparison with alendronate in postmenopausal women. Osteoporos Int. 2012 ; 23 : 317-26.
PubMed
12) Horne AM, Mihov B, Reid IR. Bone Loss After Romosozumab/Denosumab : Effects of Bisphosphonates. Calcif Tissue Int. 2018 ; 103 : 55-61.
PubMed
13) Reid IR, Horne AM, Mihov B, et al. Bone Loss After Denosumab : Only Partial Protection with Zoledronate. Calcif Tissue Int. 2017 ; 101 : 371-4.
PubMed
14) Leder BZ, Tsai JN, Uihlein AV, et al. Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study) : extension of a randomised controlled trial. Lancet. 2015 ; 386 : 1147-55.
PubMed
P.201 掲載の参考文献
1) Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab Treatment in Postmenopausal Women with Osteoporosis.N Engl J Med. 2016 ; 375 : 1532-43.
PubMed
2) Saag KG, Petersen J, Brandi ML, et al. Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis. N Engl J Med. 2017 ; 377 : 1417-27.
PubMed
3) Lewiecki EM, Blicharski T, Goemaere S, et al. A Phase III Randomized Placebo-Controlled Trial to Evaluate Efficacy and Safety of Romosozumab in Men With Osteoporosis. J Clin Endocrinol Metab. 2018 ; 103 : 3183-93.
 
4) FDA, January 16, 2019 Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. Available at : https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM629776.pdf.
 
5) FDA, January 16, 2019 Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. Available at : https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM629458.pdf.
 
6) Kang JH, Keller JJ, Lin HC. Bisphosphonates reduced the risk of acute myocardial infarction : a 2-year follow-up study. Osteoporos Int. 2013 ; 24 : 271-7.
PubMed
7) Kang JH, Keller JJ, Lin HC. A population-based 2-year follow-up study on the relationship between bisphosphonates and the risk of stroke. Osteoporos Int. 2012 ; 23 : 2551-7.
PubMed
8) Sing CW, Wong AY, Kiel DP et al. Association of Alendronate and Risk of Cardiovascular Events in Patients With Hip Fracture. J Bone Miner Res. 2018 ; 33 : 1422-34.
PubMed
9) Kranenburg G, Bartstra JW, Weijmans M, et al. Bisphosphonates for cardiovascular risk reduction : A systematic review and meta-analysis. Atherosclerosis. 2016 ; 252 : 106-15.
PubMed
10) Nitta K, Akiba T, Suzuki K, et al. Effects of cyclic intermittent etidronate therapy on coronary artery calcification in patients receiving longterm hemodialysis. Am J Kidney Dis. 2004 ; 44 : 680-8.
 
11) Caffarelli C, Montagnani A, Nuti R, et al. Bisphosphonates, atherosclerosis and vascular calcification : update and systematic review of clinical studies. Clin Interv Aging. 2017 ; 12 : 1819-28.
PubMed
12) Ylitalo R, Monkkonen J, Urtti A, et al. Accumulation of bisphosphonates in the aorta and some other tissues of healthy and atherosclerotic rabbits. J Lab Clin Med. 1996 ; 127 : 200-6.
PubMed
13) Ylitalo R, Syvala H, Tuohimaa P, et al. Suppression of immunoreactive macrophages in atheromatous lesions of rabbits by clodronate. Pharmacol Toxicol. 2002 ; 90 : 139-43.
PubMed
14) Lyles KW, Colon-Emeric CS, Magaziner JS, et al. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med. 2007 ; 357 : 1799-809.
PubMed
15) Bliuc D, Tran T, van Geel T, et al. Mortality risk reduction differs according to bisphosphonate class : a 15 -year observational study. Osteoporos Int. 2019 ; 30 : 817-28.
 
16) Ye C, Xu M, Wang S, et al. Decreased Bone Mineral Density Is an Independent Predictor for the Development of Atherosclerosis : A Systematic Review and Meta-Analysis. PLoS One. 2016 ; 11 : e 0154740.
 
17) Danilevicius CF, Lopes JB, Pereira RM. et al. Bone metabolism and vascular calcification. Braz J Med Biol Res. 2007 ; 40 : 435-42.
PubMed
18) 審議結果報告書 : イベニティ皮下注 105 mg シリンジ
 
19) Magoori K, Kang MJ, Ito MR, et al. Severe hypercholesterolemia, impaired fat tolerance, and advanced atherosclerosis in mice lacking both low density lipoprotein receptor-related protein 5 and apolipoprotein E. J Biol Chem. 2003 ; 278 : 11331-6.
PubMed
20) Ramsey SA, Vengrenyuk Y, Menon P, et al. Epigenome-guided analysis of the transcriptome of plaque macrophages during atherosclerosis regression reveals activa-tion of the Wnt signaling pathway. PLoS Genet. 2014 ; 10 : e 1004828.
 
21) Borrell-Pages M, Romero JC, Badimon L. LRP 5 deficiency down-regulates Wnt signalling and promotes aortic lipid infiltration in hypercholesterolaemic mice. J Cell Mol Med. 2015 ; 19 : 770-7.
 
22) Wang F, Liu Z, Park SH, et al. Myeloid β-catenin deficiency exacerbates atherosclerosis in low-density lipoprotein receptor-deficient mice. Arterioscler Thromb Vasc Biol. 2018 ; 38 : 1468-78.
 
23) Srivastava R, Zhang J, Go GW, et al. Impaired LRP 6 -TCF 7 L 2 activity enhances smooth muscle cell plasticity and causes coronary artery disease. Cell Rep. 2015 ; 13 : 746-59.
 
24) Lee DK, Nathan Grantham R, Trachte AL, et al. Activation of the canonical Wnt/beta-catenin pathway enhances mon-ocyte adhesion to endothelial cells. Biochem Biophys Res Commun. 2006 ; 347 : 109-16.
 
25) Ezan J, Leroux L, Barandon L, et al. FrzA/sFRP- 1, a secreted antagonist of the Wnt-Frizzled pathway, controls vascular cell prolif-eration in vitro and in vivo. Cardiovasc Res. 2004 ; 63 : 731-8.
 
26) Marchand A, Atassi F, Gaaya A, et al. The Wnt/beta-catenin pathway is activated dur-ing advanced arterial aging in humans. Aging Cell. 2011 ; 10 : 220-32.
 
27) Jorgensen HS, Winther S, Dupont L, et al. Sclerostin is not associated with cardiovascular event or fracture in kidney transplantation candidates. Clin Nephrol. 2018 ; 90 : 18-26.
PubMed
28) Claes KJ, Viaene L, Heye S, et al. Sclerostin : another vascular calcification inhibitor? J Clin Endocrinol Metab. 2013 ; 98 : 3221-8.
PubMed
29) Kuipers AL, Miljkovic I, Carr JJ, et al. Association of circulating sclerostin with vascular calcification in Afro-Caribbean men. Atherosclerosis. 2015 ; 239 : 218-23.
PubMed
30) Evenepoel P, Goffin E, Meijers B, et al. Sclerostin Serum levels and vascular calcification pro-gression in prevalent renal transplant recipients. J Clin Endocrinol Metab. 2015 ; 100 : 4669-76.
 
31) イベニティ市販後調査結果 (調査実施期間 : 2019/3/4-2019/9/3)
 
32) Hata J, Tanizaki Y, Kiyohara Y, et al. Ten year recurrence after first ever stroke in a Japanese community : the Hisayama study. J Neurol Neurosurg Psychiatry. 2005 ; 76 : 368-72.
 

書評

最近チェックした商品履歴

Loading...