Journal Article

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

Diaz-Curiel, M., Balogh, A., Brandi, M-L., Goemaere, S., Reginster, J-Y., Benhamou, C. L., Bruyère, O., Felsenberg, D., Kaufman, J-M., Roux, C., Badurski, J., Wark, J., Devogelaer, J. P.

2012

Overview

Summary 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® scores were calculated. The effect of strontium ranelate on fracture incidence was evaluated by comparison with a FRAX®-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®-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.

• Publisher: Springer-Verlag,Springer Nature B.V,Springer Science & Business Media B.V
• Subject: Aged / Aged, 80 and over / Bone density / Bone Density - drug effects / Bone Density Conservation Agents - administration & dosage / Bone Density Conservation Agents - adverse effects / Bone Density Conservation Agents - therapeutic use / Bone mineral density / Double-Blind Method / Drug Administration Schedule / Drug therapy / Endocrinology / Female / Femur Neck - physiopathology / Follow-Up Studies / Fractures / General & internal medicine / Hip / Hip Joint - physiopathology / Human health sciences / Humans / Long term / Lumbar Vertebrae - physiopathology / Medicine / Medicine & Public Health / Menopause / Médecine générale & interne / Organometallic Compounds - administration & dosage / Organometallic Compounds - adverse effects / Organometallic Compounds - therapeutic use / Original / Original Article / Orthopedics / Osteoporosis / Osteoporosis, Postmenopausal - complications / Osteoporosis, Postmenopausal - drug therapy / Osteoporosis, Postmenopausal - physiopathology / Osteoporotic Fractures - etiology / Osteoporotic Fractures - physiopathology / Osteoporotic Fractures - prevention & control / Patient safety / Post-menopause / Rheumatology / Risk assessment / Sciences de la santé humaine / Strontium / Thiophenes - administration & dosage / Thiophenes - adverse effects / Thiophenes - therapeutic use / Time Factors / Treatment Outcome / Vertebrae