Effects of long-term strontium ranelate treatment on vertebral fracture risk in postmenopausal women with osteoporosis.
Osteoporos Int
; 20(10): 1663-73, 2009 Oct.
Article
en En
| MEDLINE
| ID: mdl-19153678
ABSTRACT
SUMMARY:
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.INTRODUCTION:
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.METHODS:
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.RESULTS:
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(R), 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.CONCLUSION:
In this 4- and 5-year study, strontium ranelate is an effective and safe treatment for long-term treatment of osteoporosis in postmenopausal women.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Compuestos Organometálicos
/
Tiofenos
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Osteoporosis Posmenopáusica
/
Fracturas de la Columna Vertebral
/
Conservadores de la Densidad Ósea
/
Fracturas Osteoporóticas
Tipo de estudio:
Clinical_trials
/
Etiology_studies
/
Risk_factors_studies
Aspecto:
Patient_preference
Límite:
Aged
/
Female
/
Humans
/
Middle aged
Idioma:
En
Revista:
Osteoporos Int
Asunto de la revista:
METABOLISMO
/
ORTOPEDIA
Año:
2009
Tipo del documento:
Article
País de afiliación:
Francia