 |
|
|
 |
Longterm Effect of Intermittent Cyclical Etidronate Therapy on Corticosteroid-Induced Osteoporosis in Japanese Patients with Connective Tissue Disease:
7-Year Followup
SHINJI SATO, TETSUYA TAKADA, YUMIKO KATSUKI, NORIKO KIMURA, YUKO KANEKO, AKIRA SUWA, MICHITO HIRAKATA, and MASATAKA KUWANA
ABSTRACT. Methods. One hundred two Japanese patients who originally participated in a 3-year prospective randomized study were enrolled into an open-label followup study. All patients had received > 7.5 mg of prednisolone daily for at least 90 days before entry into the original study and were randomly assigned to 2 treatment arms: E, those receiving etidronate disodium (200 mg per day) for 2 weeks together with 3.0 g of calcium lactate and 0.75 µg of alphacalcidol daily; and C, controls receiving only the latter. Endpoints included changes from baseline in bone mineral density (BMD) of the lumbar spine and the rate of new vertebral fractures. Results. The mean (± SD) lumbar spine BMD had increased by 5.9% ± 8.8% (p = 0.00007) and 2.2% ± 5.8% (p = 0.013) from baseline after 7 years in groups E and C, respectively. This improvement in BMD in group E was significantly better than in group C (p = 0.02). The frequency of new vertebral fractures was lower in group E, resulting in reduction of the risk of such new fractures by 67% at year 7 (odds ratio 3.000; 95% confidence interval, 0.604–14.90; p = 0.18). There were no severe adverse events in group E during our study. Conclusion. Our results indicate that longterm (up to 7 years) intermittent cyclical etidronate therapy is safe and effective for prevention and treatment of corticosteroid-induced osteoporosis in patients with connective tissue diseases. (First Release Nov 15 2007; J Rheumatol 2008;35:142-6) Key Indexing Terms:
CORTICOSTEROID-INDUCED OSTEOPOROSIS
From the Department of Internal Medicine, Keio University, School of Medicine, Tokyo; and the Division of Rheumatology, Department of Internal Medicine, Tokai University School of Medicine, Kanagawa, Japan. S. Sato, MD; T. Takada, MD; Y. Katsuki, MD; N. Kimura, MD; Y. Kaneko, MD; M. Hirakata, MD; M. Kuwana, MD, Department of Internal Medicine, Keio University; A. Suwa, MD, Division of Rheumatology, Department of Internal Medicine, Tokai University School of Medicine. Address reprint requests to Dr. S. Sato, Department of Internal Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan. E-mail: shins@sc.itc.keio.ac.jp Accepted for publication September 7, 2007. |