Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis.

in Osteoporosis International (2012), 23

In an open-label extension study, BMD increased continuously with strontium ranelate over 10 years in osteoporotic women (P < 0.01). Vertebral and nonvertebral fracture incidence was lower between 5 and ... [more ▼]

In an open-label extension study, BMD increased continuously with strontium ranelate over 10 years in osteoporotic women (P < 0.01). Vertebral and nonvertebral fracture incidence was lower between 5 and 10 years than in a matched placebo group over 5 years (P < 0.05). Strontium ranelate's antifracture efficacy appears to be maintained long term. INTRODUCTION: Strontium ranelate has proven efficacy against vertebral and nonvertebral fractures, including hip, over 5 years in postmenopausal osteoporosis. We explored long-term efficacy and safety of strontium ranelate over 10 years. METHODS: Postmenopausal osteoporotic women participating in the double-blind, placebo-controlled phase 3 studies SOTI and TROPOS to 5 years were invited to enter a 5-year open-label extension, during which they received strontium ranelate 2 g/day (n = 237, 10-year population). Bone mineral density (BMD) and fracture incidence were recorded, and FRAX(R) scores were calculated. The effect of strontium ranelate on fracture incidence was evaluated by comparison with a FRAX(R)-matched placebo group identified in the TROPOS placebo arm. RESULTS: The patients in the 10-year population had baseline characteristics comparable to those of the total SOTI/TROPOS population. Over 10 years, lumbar BMD increased continuously and significantly (P < 0.01 versus previous year) with 34.5 +/- 20.2% relative change from baseline to 10 years. The incidence of vertebral and nonvertebral fracture with strontium ranelate in the 10-year population in years 6 to 10 was comparable to the incidence between years 0 and 5, but was significantly lower than the incidence observed in the FRAX(R)-matched placebo group over 5 years (P < 0.05); relative risk reductions for vertebral and nonvertebral fractures were 35% and 38%, respectively. Strontium ranelate was safe and well tolerated over 10 years. CONCLUSIONS: Long-term treatment with strontium ranelate is associated with sustained increases in BMD over 10 years, with a good safety profile. Our results also support the maintenance of antifracture efficacy over 10 years with strontium ranelate. [less ▲]

Evolution récente de l'incidence des fractures de hanche et de la consommation de médicaments anti-ostéoporotiques en Belgique

in Revue du Rhumatisme (2011, December), 78(Suppl. 5), 43-44

Étude de cas : allégations de santé dans le domaine de la santé osseuse

Conference (2011, November 16)

Words, words, words

in Archives of Public Health (2011), 69(1),

Recommendations for the design of clinical trials to be conducted by food and food supplements, in order to be granted the right to use health claims in osteoporosis (in collaboration with GREES)

Conference (2011, March 25)

Hospitalisation costs of hip fractures in Belgium

in Osteoporosis International (2011, March), 22(Suppl.1), 332

Strontium ranelate increases cell viability in IL-1 beta stimulated human chondrocytes

in Osteoporosis International (2011, March), 22(Suppl.1), 53-54384

Reimbursement of drugs against osteoporosis based on FRAX® instead of the current criteria would reduce by 30% the cost (in a societal perspective) of anti-osteoporosis treatment in Belgium

in Osteoporosis International (2011, March), 22(Suppl.1), 333-334

Incidence of hip fracture in Belgium between 2000 and 2007 and future projections

in Osteoporosis International (2011, March), 22(Suppl.1), 145

Stable precision over time when assessing the cartilage loss on knee osteoarthritis radiograph

in Osteoporosis International (2011, March), 22(Suppl.1), 42-43246