Effects of long-term strontium ranelate treatment on vertebral fracture risk in postmenopausal women with osteoporosis
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.
- Effects of long-term strontium ranelate treatment on vertebral fracture risk in postmenopausal women with osteoporosis
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Volume 20, Issue 10 , pp 1663-1673
- Cover Date
- Print ISSN
- Online ISSN
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- Bone densitometry
- Osteoporotic fracture
- Osteoporosis treatment
- Strontium ranelate
- Industry Sectors
- Author Affiliations
- 1. Faculty Laennec, Claude Bernard University, Rue G Paradin, 69437, Lyon Cedex 03, France
- 2. 4 rue des Pierres Plantées, 69001, Lyon, France
- 3. Service de Rhumatologie B, Université Paris Descartes, Hôpital Cochin, 27 rue du Faubourg St Jacques, 75014, Paris, France
- 4. Divisione di Endocrinologia, Istituto Auxologico Italiano, Via Ariosto, 13, 20145, Milan, Italy
- 5. Servicio de Medicina Interna, Fundación Jiménez Diaz, Avenida de los Reyes Catolicos, 28040, Madrid, Spain
- 6. Department of Medicine, University of Cambridge, Addenbrooke’s Hospital, Cambridge, CB1 2QQ, England
- 7. MAPI Values, 15 Court Square, Suite 620, Boston, MA, 02108, USA
- 8. Service de Rhumatologie A, Hôpital Cochin, AP-HP Universite Paris Descartes, Faculte De Medecine, Service de densitométrie Osseuse, 27 rue du Faubourg St Jacques, 75014, Paris, France
- 9. Dipartimento Medicina Interna, Consultant, Università degli Studi Torino, Corso Dogliotti, 14, 10126, Turin, Italy
- 10. Department of Medicine & Rheumatology, Center of Osteoporosis and Osteo-articular Diseases, Bialystok, PL15-461, Poland
- 11. Department of Medicine, Royal Melbourne Hospital, Clinical Science Building, 3050, Parkville, VIC, Australia
- 12. Service de Chimie Médicale, Centre Hospitalier Universitaire de Liège, Hôpital du Sart Tilman, 4000 Liège 1, Belgium
- 13. Unité Exploration du Métabolisme Osseux, CHU Brull, 45 quai Godefroid Kurth, 4020, Liège, Belgium