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J Bone Miner Metab. 2016 Nov;34(6):646-654. Epub 2015 Aug 26.

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.

Author information

1
First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
2
Department of Radiology, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
3
Department of Internal Medicine, Hokkaido University, Sapporo, Japan.
4
Inflammation and Immunology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
5
Department of Rheumatology, Sagamihara National Hospital, National Hospital Organization, Sagamihara, Kanagawa, Japan.
6
Department of Rheumatology, Hiroshima Rheumatology Clinic, Hiroshima, Japan.
7
Department of Bioregulatory Medicine, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.
8
Hokkaido Medical Center for Rheumatic Diseases, Sapporo, Japan.
9
Clinical Immunology and Rheumatology, Osaka City University, Osaka, Japan.
10
Department of Internal Medicine, Sasebo Central Hospital, Nagasaki, Japan.
11
Unit of Translational Medicine, Department of Immunology and Rheumatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
12
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.

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.

KEYWORDS:

Alendronate; Autoimmune disease; Glucocorticoid; Osteoporosis

PMID:
26308708
DOI:
10.1007/s00774-015-0709-8
[Indexed for MEDLINE]

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