, Volume 70, Issue 6, pp 733-759

Strontium Ranelate

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Abstract

This is a review of the pharmacology of strontium ranelate (Protelos®, Protos®, Protaxos®, Bivalos®, Osseor®), and its efficacy and tolerability in the treatment of patients with postmenopausal osteoporosis. Strontium ranelate is a divalent strontium salt of ranelic acid that is capable of increasing bone formation and reducing bone resorption, thereby uncoupling and rebalancing bone turnover in favour of bone formation. The drug is effective in reducing the risk of fractures, including both vertebral and nonvertebral fractures, in patients with postmenopausal osteoporosis, according to data from two large, double-blind, placebo-controlled, multicentre trials of 5 years’ duration, and reduced the risk of hip fracture in high-risk patients in a post hoc analysis of one trial. Moreover, data from patients who continued to receive the drug during the 3-year extension phases of these trials indicate that strontium ranelate continues to provide protection against new vertebral fractures and nonvertebral fractures for up to 8 years of therapy. It also improves bone mineral density at numerous sites and both increases markers of bone formation and decreases markers of bone resorption. Strontium ranelate is administered orally as a suspension and is generally well tolerated. The nature of adverse events was generally similar regardless of treatment duration in clinical trials, with the most commonly reported being nausea and diarrhoea over 5 years of treatment, and memory loss and diarrhoea during longer-term treatment. Although an increased risk of venous thromboembolism was associated with strontium ranelate relative to placebo over 5 years of treatment in a pooled analysis of clinical trials, postmarketing data have not confirmed this finding. Overall, the clinical data available suggest that strontium ranelate is an effective and generally well tolerated option for the first-line treatment of postmenopausal osteoporosis.

Various sections of the manuscript reviewed by: M. Kleerekoper, Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, Michigan, USA; M. Larrosa, Rheumatology, Hospital de Sabadell, Barcelona, Spain; P.J. Meunier, INSERM Research Unit, Faculty Laennec, Lyon, France; J.Y. Reginster, Department of Public Health Sciences, University of Liège, Liège, Belgium.

Data Selection

Sources: Medical literature published in any language since 1980 on ‘strontium ranelate’, identified using MEDLINE and EMBASE, supplemented by AdisBase (a proprietary database). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.
Search strategy: MEDLINE, EMBASE and AdisBase search terms were ‘strontium ranelate’ and (‘postmenopausal osteoporosis’ or ‘postmenopause osteoporosis’). Searches were last updated 29 March 2010.
Selection: Studies in patients with postmenopausal osteoporosis who received strontium ranelate. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.
Index terms: Strontium ranelate, osteoporosis, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability, pharmacoeconomics.