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- Title
Effects of long-term strontium ranelate treatment on vertebral fracture risk in postmenopausal women with osteoporosis.
- Authors
Meunier, P. J.; Roux, C.; Ortolani, S.; Diaz-Curiel, M.; Compston, J.; Marquis, P.; Cormier, C.; Isaia, G.; Badurski, J.; Wark, J. D.; Collette, J.; Reginster, J. Y.
- Abstract
Vertebral fractures are a major adverse consequence of osteoporosis. In a large placebo-controlled trial in postmenopausal women with osteoporosis, strontium ranelate reduced vertebral fracture risk by 33% over 4 years, confirming the role of strontium ranelate as an effective long-term treatment in osteoporosis. Osteoporotic vertebral fractures are associated with increased mortality, morbidity, and loss of quality-of-life (QoL). Strontium ranelate (2 g/day) was shown to prevent bone loss, increase bone strength, and reduce vertebral and peripheral fractures. The preplanned aim of this study was to evaluate long-term efficacy and safety of strontium ranelate. A total of 1,649 postmenopausal osteoporotic women were randomized to strontium ranelate or placebo for 4 years, followed by a 1-year treatment-switch period for half of the patients. Primary efficacy criterion was incidence of patients with new vertebral fractures over 4 years. Lumbar bone mineral density (BMD) and QoL were also evaluated. Over 4 years, risk of vertebral fracture was reduced by 33% with strontium ranelate (risk reduction = 0.67, p < 0.001). Among patients with two or more prevalent vertebral fractures, risk reduction was 36% ( p < 0.001). QoL, assessed by the QUALIOST®, was significantly better ( p = 0.025), and patients without back pain were greater ( p = 0.005) with strontium ranelate than placebo over 4 years. Lumbar BMD increased over 5 years in patients who continued with strontium ranelate, while it decreased in patients who switched to placebo. Emergent adverse events were similar between groups. In this 4- and 5-year study, strontium ranelate is an effective and safe treatment for long-term treatment of osteoporosis in postmenopausal women.
- Subjects
STRONTIUM ranelate; BONE fractures; OSTEOPOROSIS in women; MORTALITY; BONE density; PATIENTS
- Publication
Osteoporosis International, 2009, Vol 20, Issue 10, p1663
- ISSN
0937-941X
- Publication type
Article
- DOI
10.1007/s00198-008-0825-6