| 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 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. 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. |
| Authors | Shinji Sato, Tetsuya Takada, Yumiko Katsuki, Noriko Kimura, Yuko Kaneko, Akira Suwa, Michito Hirakata, Masataka Kuwana
(Affiliation: Department of Internal Medicine, Keio University, School of Medicine, Tokyo, Japan. shins at sc.itc.keio.ac.jp)
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| Journal | The Journal of rheumatology
(J Rheumatol)
Vol. 35
Issue 1
Pg. 142-6
(Jan 2008)
ISSN: 0315-162X Canada |
| PMID | 18050368
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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| Chemical References |
- Adrenal Cortex Hormones
- Bone Density Conservation Agents
- Etidronic Acid
|
| Topics |
- Adrenal Cortex Hormones
(adverse effects)
- Adult
- Bone Density
(drug effects)
- Bone Density Conservation Agents
(administration & dosage, adverse effects)
- Connective Tissue Diseases
(drug therapy)
- Drug Administration Schedule
- Etidronic Acid
(administration & dosage, adverse effects)
- Female
- Follow-Up Studies
- Humans
- Japan
- Lumbar Vertebrae
(drug effects)
- Male
- Middle Aged
- Osteoporosis
(chemically induced, prevention & control)
- Time
|