Long-term treatment of postmenopausal osteoporosis with strontium ranelate: results at 8 years.

Abstract

OBJECTIVES:

Strontium ranelate 2 g/day has proven efficacy against vertebral and nonvertebral fracture over 5 years in postmenopausal osteoporosis, though many women require longer-term treatment. This article describes the efficacy, safety, and tolerability of this agent over 8 years.

METHODS:

Postmenopausal osteoporotic women having participated in the 5-year efficacy trials SOTI and TROPOS were invited to enter a 3-year open-label extension study. The results presented here focus on patients who received strontium ranelate for 8 years.

RESULTS:

At the extension baseline, the population treated for 8 years (n=879; 79.1+/-5.6 years) had femoral neck T-score of -2.61+/-0.71. The cumulative incidences of new vertebral and nonvertebral fractures (13.7% and 12.0%, respectively) over years 6 to 8 were non-statistically different from the cumulative incidences in the first 3 years of the original studies (11.5% and 9.6%). Lumbar spine, femoral neck, and total hip bone mineral density (BMD) increased throughout the 8-year period. Annual relative change in BMD was significant at every visit, except the 8-year visit for femoral neck and total hip BMD. Strontium ranelate was safe and well tolerated over 8 years.

CONCLUSIONS:

Long-term treatment with strontium ranelate 2 g/day in postmenopausal osteoporotic women leads to continued increases in BMD at all sites. The data also provide some evidence for a sustained antifracture efficacy.

• Authors: J Y Reginster, O Bruyère, A Sawicki, A Roces-Varela, P Fardellone, A Roberts, J P Devogelaer
• Journal: Bone (Bone) Vol. 45 Issue 6 Pg. 1059-64 (Dec 2009) ISSN: 1873-2763 [Electronic] United States
• PMID: 19679207 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• Aged
• Bone Density (drug effects)
• Bone Density Conservation Agents (adverse effects, pharmacology, therapeutic use)
• Female
• Femur Neck (drug effects, physiopathology)
• Fractures, Bone (complications, drug therapy, epidemiology, physiopathology)
• Hip (physiopathology)
• Humans
• Incidence
• Lumbar Vertebrae (drug effects, physiopathology)
• Organometallic Compounds (adverse effects, pharmacology, therapeutic use)
• Osteoporosis, Postmenopausal (complications, drug therapy, physiopathology)
• Patient Compliance
• Thiophenes (adverse effects, pharmacology, therapeutic use)
• Time Factors