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Strontium ranelate reduces risk of vertebral fracture in young postmenopausal women with severe osteoporosis, study suggests

Thursday, December 18 2008 | Comments
Evidence Grade 3 What's This?

Treatment with strontium ranelate--a drug used commonly to treat osteoporosis in Europe but not approved by the Food and Drug Administration--decreases the risk of vertebral fractures in young postmenopausal women who have severe osteoporosis, data suggest.

Researchers analyzed data from a subset of participants of the Spinal Osteoporosis Therapeutic Intervention trial, an international, double-blind, randomized controlled study. The subset of participants for the current study (n=353) were aged 50 to 65 years, had at least 1 vertebral fracture, and a lumbar spine bone mineral density (BMD) of 0.840 g/cm2 or less. Participants were randomized to receive strontium 2 g/day (n=168) or placebo (n=185). All of the women also received daily calcium and vitamin D supplements at lunchtime.

The study's primary endpoint was the incidence of patients experiencing a new vertebral fracture. Secondary endpoints included incidence of nonvertebral fractures, and spine and hip BMD changes.

Over 3 years, strontium significantly reduced the risk of vertebral fracture by 43% (relative risk [RR], 0.57; 95% CI, 0.36-0.92; P=.019). This reduction of risk was sustained over the 4 years of study follow-up, with a reduction of 35% in the strontium group compared with placebo (RR, 0.65; 95% CI, 0.42-0.99; P=.049). During the 3-year period, the incidence of vertebral fractures was 16.9% in the treatment group and 29.6% among placebo recipients. In the 4-year period, the respective incidence rates for vertebral fracture were 21.6% and 32.8%. The data showed no difference in the incidence of nonvertebral fractures between the 2 groups over 4 years (14.5% in the treatment  group and 14.6% in the placebo groups).

Treatment with strontium was also associated with a positive change in BMD from baseline to 3 years, with mean increases of 11.8% at the spine and 4.5% at the hip. In comparison, the placebo group showed mean decreases in BMD of 2.8% at the spine and 3.0% at the hip. Over 4 years, the BMD increased further in the strontium group with a mean change of 15.8% and 7.1% at the spine and hip, respectively, while it remained lower than baseline values in the placebo group with mean changes of -2.4% and -2.8% at these 2 sites (significant difference between groups;  P<.001 at both sites). (Roux C, et al. Ann Rheum Dis 2008;67:1736-1738.)

This information concerns a use that has not been approved by the Food and Drug Administration.

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