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논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2018.1
- 수록면
- 22 - 28 (7page)
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Objectives: This postmarketing, observational study evaluated the safety and effectiveness of monthly intravenous (IV) ibandronate in Japanese patients with osteoporosis. Methods: Eligible patients received monthly IV ibandronate 1mg for 12 months. Adverse drug reactions (ADRs) were evaluated. Changes in bone mineral density (BMD) and bone turnover markers (BTMs) were assessed using matched t-test analysis. Cumulative fracture rates were analyzed by Kaplan-Meier methodology. Results: In total, 1062 patients were enrolled, of whom 1025 (n= 887 women, n= 138 men) were treated. Mean patient age was 77 years. Seventy-five ADRs were reported in 54 patients (5.26%). Four patients (0.39%) experienced serious ADRs, including one case of osteonecrosis of the jaw. Acute-phase reactions occurred in 21 patients (2.04%), and half of them arose after the first ibandronate injection. No new safety concerns were identified. Significant increases in BMD at 12 months relative to baseline were observed at the lumbar spine (4.84%, n= 187; 95% confidence interval [CI], 3.47%-6.21%), femoral neck (2.73%, n= 166; 95% CI, 1.46%-4.01%), and total hip (1.93%, n= 133; 95% CI, 0.80%-3.07%). Significant reductions were observed in all BTMs at 12 months (n = 174 in tartrate-resistant acid phosphatase-5b, n = 101 in procollagen type 1 N-terminal propeptide at baseline). The cumulative incidence of nontraumatic,new vertebral and nonvertebral fractures was 3.16% (95% CI, 2.12%-4.70%). Analyses in women only showed similar results to the overall population. Conclusions: These findings confirm the favorable safety and consistent effectiveness of ibandronate, and indicate that monthly IV ibandronate would be beneficial in daily practice for the treatment of Japanese patients with osteoporosis.
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참고문헌 (21)
참고문헌 신청
Reginster JY / 2006 / Efficacy and tolerability of once-monthly oral ibandronate in postmenopausal osteoporosis: 2 year results from the MOBILE study / Ann Rheum Dis 65:654~661
Eisman JA / 2008 / Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-year results from the DIVA study / J Rheumatol 35:488~497
Miller PD / 2012 / Efficacy of monthly oral ibandronate is sustained over 5 years: the MOBILE long-term extension study / Osteoporos Int 23:1747~1756
Bianchi G / 2012 / Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension / Osteoporos Int 23:1769~1778
Harris ST / 2008 / Ibandronate and the risk of nonvertebral and clinical fractures in women with postmenopausal osteoporosis:results of a meta-analysis of phase III studies / Curr Med Res Opin 24:237~245
Eisman JA / 2008 / Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-year results from the DIVA study / J Rheumatol 35:488~497
Miller PD / 2012 / Efficacy of monthly oral ibandronate is sustained over 5 years: the MOBILE long-term extension study / Osteoporos Int 23:1747~1756
Bianchi G / 2012 / Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension / Osteoporos Int 23:1769~1778
Harris ST / 2008 / Ibandronate and the risk of nonvertebral and clinical fractures in women with postmenopausal osteoporosis:results of a meta-analysis of phase III studies / Curr Med Res Opin 24:237~245
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