期刊
BONE
卷 45, 期 6, 页码 1059-1064出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.bone.2009.08.004
关键词
BMD; Fracture risk; Long-term treatment; Safety; Strontium ranelate
资金
- Amgen
- Analis
- Bristol Myers Squibb
- Ebewee Pharma
- Genevrier
- GlaxoSmithKline
- IBSA
- Lilly
- Merckle
- Merck Sharp and Dohme
- Negma
- Novartis
- Novo-Nordisk
- NPS
- Nycomed
- Roche
- Rottapharm
- Servier
- Teijin
- Teva
- Theramex
- UCB
- Wyeth
- Zodiac
Objectives: Strontium ranelate 2 g/day has proven efficacy against vertebral and nonvertebral fracture over 5 years in postmenopausal osteoporosis, though many women require longer-term treatment. This article describes the efficacy, safety, and tolerability of this agent over 8 years. Methods: Postmenopausal osteoporotic women having participated in the 5-year efficacy trials SOTI and TROPOS were invited to enter a 3-year open-label extension study. The results presented here focus on patients who received strontium ranelate for 8 years. Results: At the extension baseline, the population treated for 8 years (n =879; 79.1 +/- 5.6 years) had femoral neck T-score of -2.61 +/- 0.71. The cumulative incidences of new vertebral and nonvertebral fractures (13.7% and 12.0%, respectively) over years 6 to 8 were non-statistically different from the cumulative incidences in the first 3 years of the original studies (11.5% and 9.6%). Lumbar spine, femoral neck, and total hip bone mineral density (BMD) increased throughout the 8-year period. Annual relative change in BMD was significant at every visit, except the 8-year visit for femoral neck and total hip BMD. Strontium ranelate was safe and well tolerated over 8 years. Conclusions: Long-term treatment with strontium ranelate 2 g/day in postmenopausal osteoporotic women leads to continued increases in BMD at all sites. The data also provide some evidence for a sustained antifracture efficacy. (C) 2009 Elsevier Inc. All rights reserved.
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