Long-term treatment of postmenopausal osteoporosis with strontium ranelate: results at 8 years.
OBJECTIVE
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.
Reginster
J Y
JY
Department of Public Health Sciences, University of Liège, Liège, Belgium. jyreginster@ulg.ac.be
Bruyère
O
O
Sawicki
A
A
Roces-Varela
A
A
Fardellone
P
P
Roberts
A
A
Devogelaer
J P
JP
D000368:Aged; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005272:Femur Neck / Q000187:drug effects / Q000503:physiopathology; D050723:Fractures, Bone / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology / Q000503:physiopathology; D006615:Hip / Q000503:physiopathology; D006801:Humans; D015994:Incidence; D008159:Lumbar Vertebrae / Q000187:drug effects / Q000503:physiopathology; D009942:Organometallic Compounds / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D010349:Patient Compliance; D013876:Thiophenes / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D013997:Time Factors
D050071:Bone Density Conservation Agents; D009942:Organometallic Compounds; D013876:Thiophenes; C081587:strontium ranelate