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

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...

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Published in:Journal of bone and mineral metabolism 2016-11, Vol.34 (6), p.646-654
Main Authors: Tanaka, Yoshiya, Mori, Hiroko, Aoki, Takatoshi, Atsumi, Tatsuya, Kawahito, Yutaka, Nakayama, Hisanori, Tohma, Shigeto, Yamanishi, Yuji, Hasegawa, Hitoshi, Tanimura, Kazuhide, Negoro, Nobuo, Ueki, Yukitaka, Kawakami, Atsushi, Eguchi, Katsumi, Saito, Kazuyoshi, Okada, Yosuke
Format: Article
Language:English
Subjects:
Adolescent
Adult
Aged
Aged, 80 and over
Alendronate - administration & dosage
Bone Density - drug effects
Female
Fractures, Bone - metabolism
Fractures, Bone - prevention & control
Glucocorticoids - administration & dosage
Glucocorticoids - adverse effects
Humans
Hydroxycholecalciferols - administration & dosage
Medicine
Medicine & Public Health
Metabolic Diseases
Middle Aged
Original Article
Orthopedics
Osteoporosis - chemically induced
Osteoporosis - drug therapy
Osteoporosis - metabolism
Rheumatic Diseases - drug therapy
Rheumatic Diseases - metabolism
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Summary: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.
ISSN:0914-8779
1435-5604
DOI:10.1007/s00774-015-0709-8