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, Masataka Kuwana

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

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 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.

Original languageEnglish
Pages (from-to)142-146
Number of pages5
JournalJournal of Rheumatology
Volume35
Issue number1
Publication statusPublished - 2008 Jan

Fingerprint

Etidronic Acid
Connective Tissue Diseases
Osteoporosis
Adrenal Cortex Hormones
Bone Density
Spine
Risk Reduction Behavior
Therapeutics
Prednisolone
Odds Ratio
Prospective Studies
Confidence Intervals
Safety

Keywords

  • Bisphosphonate
  • Bone mineral density
  • Connective tissue diseases
  • Corticosteroid-induced osteoporosis

ASJC Scopus subject areas

  • Rheumatology
  • Immunology

Cite this

Longterm effect of intermittent cyclical etidronate therapy on corticosteroid-induced osteoporosis in Japanese patients with connective tissue disease : 7-Year followup. / Sato, Shinji; Takada, Tetsuya; Katsuki, Yumiko; Kimura, Noriko; Kaneko, Yuko; Suwa, Akira; Hirakata, Michito; Kuwana, Masataka.

In: Journal of Rheumatology, Vol. 35, No. 1, 01.2008, p. 142-146.

Research output: Contribution to journalArticle

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title = "Longterm effect of intermittent cyclical etidronate therapy on corticosteroid-induced osteoporosis in Japanese patients with connective tissue disease: 7-Year followup",
abstract = "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 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.",
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AU - Katsuki, Yumiko

AU - Kimura, Noriko

AU - Kaneko, Yuko

AU - Suwa, Akira

AU - Hirakata, Michito

AU - Kuwana, Masataka

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N2 - 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 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.

AB - 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 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.

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KW - Bone mineral density

KW - Connective tissue diseases

KW - Corticosteroid-induced osteoporosis

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