Longterm effect of intermittent cyclical etidronate therapy on corticosteroid-induced osteoporosis in Japanese patients with connective tissue disease: 7-year followup.
OBJECTIVE
To determine the efficacy and safety of intermittent cyclical etidronate therapy of up to 7 years for corticosteroid-induced osteoporosis.


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 microg 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.


CONCLUSIONS
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.
Sato
Shinji
S
Department of Internal Medicine, Keio University, School of Medicine, Tokyo, Japan. shins@sc.itc.keio.ac.jp
Takada
Tetsuya
T
Katsuki
Yumiko
Y
Kimura
Noriko
N
Kaneko
Yuko
Y
Suwa
Akira
A
Hirakata
Michito
M
Kuwana
Masataka
M
D000305:Adrenal Cortex Hormones / Q000009:adverse effects*; D000328:Adult; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003240:Connective Tissue Diseases / Q000188:drug therapy*; D004334:Drug Administration Schedule; D012968:Etidronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007564:Japan; D008159:Lumbar Vertebrae / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000139:chemically induced / Q000517:prevention & control*; D013995:Time
D000305:Adrenal Cortex Hormones; D050071:Bone Density Conservation Agents; D012968:Etidronic Acid