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

Abstract

UNLABELLED:

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.

• Authors: J-Y Reginster, J-M Kaufman, S Goemaere, J P Devogelaer, C L Benhamou, D Felsenberg, M Diaz-Curiel, M-L Brandi, J Badurski, J Wark, A Balogh, O Bruyère, C Roux
• Journal: Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA (Osteoporos Int) Vol. 23 Issue 3 Pg. 1115-22 (Mar 2012) ISSN: 1433-2965 [Electronic] England
• PMID: 22124575 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Bone Density Conservation Agents
• Organometallic Compounds
• Thiophenes
• strontium ranelate

Topics

• Aged
• Aged, 80 and over
• Bone Density (drug effects)
• Bone Density Conservation Agents (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Drug Administration Schedule
• Female
• Femur Neck (physiopathology)
• Follow-Up Studies
• Hip Joint (physiopathology)
• Humans
• Lumbar Vertebrae (physiopathology)
• Organometallic Compounds (administration & dosage, adverse effects, therapeutic use)
• Osteoporosis, Postmenopausal (complications, drug therapy, physiopathology)
• Osteoporotic Fractures (etiology, physiopathology, prevention & control)
• Thiophenes (administration & dosage, adverse effects, therapeutic use)
• Time Factors
• Treatment Outcome