title: Analysis of bone metabolism during early stage and clinical benefits of early intervention with alendronate in patients with systemic rheumatic diseases treated with high-dose glucocorticoid: Early DIagnosis and Treatment of OsteopoRosis in Japan (EDITOR-J) study.
abstract: We conducted a prospective multicenter study to assess early changes in the dynamics of bone metabolism in patients with systemic connective tissue diseases following commencement of high-dose glucocorticoid therapy and the benefits of early treatment with bisphosphonate and vitamin D analogue. The subjects of this randomized controlled trial were 106 female patients with systemic connective tissue diseases treated for the first time with glucocorticoids at doses equivalent to prednisolone ≥20 mg/day (age ≥ 18 years). One week after initiation of glucocorticoid therapy, patients were randomly assigned to treatment with alfacalcidol at 1 μg/day (n = 33), alendronate 35 mg/week (n = 37), and alfacalcidol plus alendronate (n = 36). The primary endpoints were changes in lumbar spine bone density at 6 months of treatment and the frequency of bone fracture at 12 months. Commencement of glucocorticoid therapy was associated with a rapid and marked bone resorption within 1 week. The combination of alfacalcidol and alendronate administered after the first week of glucocorticoid therapy halted the pathological processes affecting bone metabolism, increased bone density, and reduced the incidence of bone fracture over a period of 12 months. Taken together, the use of the combination of alfacalcidol and alendronate improved bone metabolism, increased bone density, and significantly reduced the incidence of bone fracture during 1-year high-dose glucocorticoid therapy.
authors: First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
authors: Yoshiya
authors: Y
authors: Tanaka
authors: First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
authors: Hiroko
authors: H
authors: Mori
authors: Department of Radiology, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
authors: Takatoshi
authors: T
authors: Aoki
authors: Department of Internal Medicine, Hokkaido University, Sapporo, Japan.
authors: Tatsuya
authors: T
authors: Atsumi
authors: Inflammation and Immunology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors: Yutaka
authors: Y
authors: Kawahito
authors: Department of Rheumatology, Sagamihara National Hospital, National Hospital Organization, Sagamihara, Kanagawa, Japan.
authors: Hisanori
authors: H
authors: Nakayama
authors: Department of Rheumatology, Sagamihara National Hospital, National Hospital Organization, Sagamihara, Kanagawa, Japan.
authors: Shigeto
authors: S
authors: Tohma
authors: Department of Rheumatology, Hiroshima Rheumatology Clinic, Hiroshima, Japan.
authors: Yuji
authors: Y
authors: Yamanishi
authors: Department of Bioregulatory Medicine, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.
authors: Hitoshi
authors: H
authors: Hasegawa
authors: Hokkaido Medical Center for Rheumatic Diseases, Sapporo, Japan.
authors: Kazuhide
authors: K
authors: Tanimura
authors: Clinical Immunology and Rheumatology, Osaka City University, Osaka, Japan.
authors: Nobuo
authors: N
authors: Negoro
authors: Department of Internal Medicine, Sasebo Central Hospital, Nagasaki, Japan.
authors: Yukitaka
authors: Y
authors: Ueki
authors: Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
authors: Atsushi
authors: A
authors: Kawakami
authors: Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
authors: Katsumi
authors: K
authors: Eguchi
authors: First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
authors: Kazuyoshi
authors: K
authors: Saito
authors: First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan. y-okada@med.uoeh-u.ac.jp.
authors: Yosuke
authors: Y
authors: Okada
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019386:Alendronate / Q000008:administration & dosage*; D015519:Bone Density / Q000187:drug effects*; D005260:Female; D050723:Fractures, Bone / Q000378:metabolism / Q000517:prevention & control; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D006887:Hydroxycholecalciferols / Q000008:administration & dosage*; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced / Q000188:drug therapy / Q000378:metabolism; D012216:Rheumatic Diseases / Q000188:drug therapy / Q000378:metabolism
chemical_list: D005938:Glucocorticoids; D006887:Hydroxycholecalciferols; C008088:alfacalcidol; D019386:Alendronate
keywords: Alendronate; Autoimmune disease; Glucocorticoid; Osteoporosis