Effects of long-term strontium ranelate treatment on the risk of nonvertebral and vertebral fractures in postmenopausal osteoporosis: Results of a five-year, randomized, placebo-controlled trial.
OBJECTIVE
This study was undertaken to assess the effect of strontium ranelate on nonvertebral and vertebral fractures in postmenopausal women with osteoporosis in a 5-year, double-blind, placebo-controlled trial.


METHODS
A total of 5,091 postmenopausal women with osteoporosis were randomized to receive either strontium ranelate at 2 gm/day or placebo for 5 years. The main efficacy criterion was the incidence of nonvertebral fractures. In addition, incidence of hip fractures was assessed, by post hoc analysis, in the subset of 1,128 patients who were at high risk of fractures (age 74 years or older with lumbar spine and femoral neck bone mineral density T scores -2.4 or less). The incidence of new vertebral fractures was assessed, using the semiquantitative method described by Genant, in the 3,646 patients in whom spinal radiography (a nonmandatory procedure) was performed during the course of the study. Fracture data were analyzed using the Kaplan-Meier survival method.


RESULTS
Of the 5,091 patients, 2,714 (53%) completed the study up to 5 years. The risk of nonvertebral fracture was reduced by 15% in the strontium ranelate group compared with the placebo group (relative risk 0.85 [95% confidence interval 0.73-0.99]). The risk of hip fracture was decreased by 43% (relative risk 0.57 [95% confidence interval 0.33-0.97]), and the risk of vertebral fracture was decreased by 24% (relative risk 0.76 [95% CI 0.65-0.88]) in the strontium ranelate group. After 5 years, the safety profile of strontium ranelate remained unchanged compared with the 3-year findings.


CONCLUSIONS
Our findings indicate that treatment of postmenopausal osteoporosis with strontium ranelate results in a sustained reduction in the incidence of osteoporotic nonvertebral fractures, including hip fractures, and vertebral fractures over 5 years.
University of Liège, Liège, Belgium.
Jean-Yves
JY
Reginster
Dieter
D
Felsenberg
Steven
S
Boonen
Adolfo
A
Diez-Perez
Rene
R
Rizzoli
Maria-Luisa
ML
Brandi
Tim D
TD
Spector
Kim
K
Brixen
Stefan
S
Goemaere
Catherine
C
Cormier
Adam
A
Balogh
Pierre D
PD
Delmas
Pierre J
PJ
Meunier
D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D050723:Fractures, Bone / Q000517:prevention & control*; D006620:Hip Fractures / Q000517:prevention & control; D006801:Humans; D008137:Longitudinal Studies; D009942:Organometallic Compounds / Q000627:therapeutic use*; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D013124:Spinal Injuries / Q000517:prevention & control; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome
D050071:Bone Density Conservation Agents; D009942:Organometallic Compounds; D013876:Thiophenes; C081587:strontium ranelate