دورية أكاديمية
A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: effects on bone density and fracture
| العنوان: | A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: effects on bone density and fracture |
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| المؤلفون: | Palacios, Santiago, Silverman, Stuart L, de Villiers, Tobie J, Levine, Amy B, Goemaere, Stefan, Brown, Jacques P, De Cicco Nardone, Fiorenzo, Williams, Robert, Hines, Teresa L, Mirkin, Sebastian, Chines, Arkadi A |
| المصدر: | MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY ; ISSN: 1072-3714 |
| سنة النشر: | 2015 |
| المجموعة: | Ghent University Academic Bibliography |
| مصطلحات موضوعية: | Medicine and Health Sciences, Fracture, Osteoporosis, Bazedoxifene, Selective estrogen receptor modulator, Bone mineral density, CONTINUING OUTCOMES RELEVANT, ESTROGEN-RECEPTOR MODULATOR, VERTEBRAL FRACTURE, CLINICAL-TRIAL, CONTROLLED PHASE-3, BREAST-CANCER, DOUBLE-BLIND, RISK, RALOXIFENE, RISEDRONATE |
| الوصف: | Objective: In a 3-year randomized, double-blind, osteoporosis treatment study (N = 7,492), bazedoxifene 20 mg and bazedoxifene 40 mg significantly (P < 0.05) reduced the risk of new vertebral fractures by 42% and 37%, respectively, compared with placebo in postmenopausal women with osteoporosis. This study evaluated the long-term (7-y) efficacy and safety of bazedoxifene in generally healthy postmenopausal women with osteoporosis. Methods: This was a second 2-year extension of the 3-year multicenter outpatient core study. During extension I (years 4-5), women receiving bazedoxifene 40 mg transitioned to bazedoxifene 20 mg. In extension II (years 6-7; N = 1,530), all bazedoxifene-treated women continued bazedoxifene 20 mg. Main outcome measures included year 7 endpoints: incidences of new vertebral and nonvertebral fractures, bone mineral density changes, and safety assessments. Results: At 7 years, the cumulative incidences of new vertebral fractures were significantly lower in the bazedoxifene (6.4%) and bazedoxifene 20 mg (7.6%) groups than in the placebo group (9.9%); the relative risk reductions were 36.5% and 30.4%, respectively (both P < 0.001). Bazedoxifene had no effect on the overall incidence of nonvertebral fractures (bazedoxifene, 11.2%; bazedoxifene 20 mg, 12.0%; placebo, 10.8%). The mean changes from baseline in lumbar spine bone mineral density were 2.95%, 2.73%, and 2.19%, respectively. Seven-year decreases in total hip bone mineral density were significantly smaller in the bazedoxifene (-1.15%) and bazedoxifene 20 mg (-1.19%) groups than in the placebo group (-2.53%; P 0.002). Bazedoxifene showed a favorable safety/tolerability profile across 7 years, with similar adverse events, serious adverse events, and study discontinuations in all groups. Conclusions: Efficacy and safety of bazedoxifene are sustained across 7 years in postmenopausal women with osteoporosis. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | https://biblio.ugent.be/publication/7104804Test; http://hdl.handle.net/1854/LU-7104804Test; http://dx.doi.org/10.1097/gme.0000000000000419Test; https://biblio.ugent.be/publication/7104804/file/7105943Test |
| DOI: | 10.1097/gme.0000000000000419 |
| الإتاحة: | https://doi.org/10.1097/gme.0000000000000419Test https://biblio.ugent.be/publication/7104804Test http://hdl.handle.net/1854/LU-7104804Test https://biblio.ugent.be/publication/7104804/file/7105943Test |
| حقوق: | No license (in copyright) ; info:eu-repo/semantics/restrictedAccess |
| رقم الانضمام: | edsbas.D881BFFD |
| قاعدة البيانات: | BASE |
| DOI: | 10.1097/gme.0000000000000419 |
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