Fillers POEM

Strontium reduces risk of symptomatic vertebral fracture

BMJ 2004; 328 doi: (Published 13 May 2004) Cite this as: BMJ 2004;328:0-e

Question Does strontium ranelate improve clinical outcomes in patients with postmenopausal osteoporosis and at least one vertebral fracture?

Synopsis Strontium ranelate is thought to both increase the formation of new bone and decrease bone resorption. In this double blind, randomised controlled trial postmenopausal women with osteoporosis and at least one vertebral compression fracture were randomly assigned (allocation concealment uncertain) to 2 g strontium powder a day or placebo. The powder could be taken once or twice daily, and follow up consisted of annual radiographs and patients' reports of any acute back pain or fracture. Although 1649 patients were initially recruited, those without follow up radiographs were excluded from the analysis, leaving 1442 (719 receiving strontium, 723 receiving placebo) for the intention to treat analysis. The patients had a mean age of 69 years, a mean body mass index of 26.1, and a mean of 2.2 vertebral fractures at baseline. A total of 1260 completed the planned three year follow up. The study was funded by the drug manufacturer, the French pharmaceutical company Servier, which held the data and conducted all the statistical analyses for the authors. After three years, the risk of symptomatic vertebral fracture, the more important patient oriented outcome, was lower in the treatment group (11.3% v 17.4%; p < 0.001; absolute risk reduction = 6.1%; number needed to treat = 17). Strontium treatment also significantly reduced the risk of radiographic vertebral fractures (fractures noted on film but not necessarily apparent to the patient) (20.9% v 32.8%; p < 0.001; absolute risk reduction = 10.9%; number needed to treat = 9). There was no significant difference in the risk of non-vertebral fracture (15.6% v 16.9%) and a non-significant trend towards fewer episodes of back pain in the strontium group (17.7% v 21.3%; p = 0.07). Bone mineral density increased in the spine, hip, and femoral neck in the strontium group compared with no change or a small decline in the placebo group. Adverse events were generally similar in the two groups, with slightly more diarrhoea in the strontium group (6.1% v 3.6%; p = 0.02).

Bottom line Strontium ranelate prevents one symptomatic vertebral fracture for every 17 postmenopausal women with a history of vertebral fracture who take it for three years.

Level of evidence 1b (see Individual randomised controlled trials (with narrow confidence interval)

Meunier PJ, Roux C, Seeman E, et al. The effects of strontium ranelate on the risk of vertebral fracture in women with postmenopausal osteoporosis. N Engl J Med 2004;350: 459-68

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  • * Patient-Oriented Evidence that Matters. See editorialBMJ 2002;325: 983

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