The efficacy of strontium ranelate (Protelos°), prescribed to prevent osteoporosis-related fractures, is at best limited, and it offers no advantage over alendronic acid, a standard bisphosphonate. Its adverse effects are disproportionate: deep vein thrombosis and pulmonary embolism; sometimes fatal hypersensitivity, starting with a rash; muscle damage; confusion and hallucinations; etc.

In September 2011, the French health authority placed restrictions on the reimbursement of Protelos°, a drug commercialised as a treatment for osteoporosis in post-menopausal women. It is now reimbursed only when a bisphosphonate treatment has failed or been ruled out, or for patients not at risk from deep vein thrombosis. And from 1st January 2012, the reimbursement rate for Protelos° by France's national health insurance system dropped from 65% to 30%. 

The French health products safety agency (Afssaps) has recommended “restricting the use of this drug to patients aged under 80 who have a contra-indication or an intolerance of bisphosphonates and a high risk of fractures”, and to inform patients that they must stop taking the drug immediately if they develop a skin rash.

In practice, when a bisphosphonate cannot be used, raloxifene, an oestrogen agonist/antagonist, is a second-line preventive option for recurrent fractures, but its many adverse effects must be taken into account.

©Prescrire 1 March 2012

"Strontium ranelate: too many adverse effects (continued)" Prescrire Int 2012; 21 (125): 72. (Pdf, subscribers only).