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Strontium ranelate for osteoporosis in men. More dangerous than beneficial

    Prescrire International
    |July 20, 2013
    PubMed

    Insights

    Market release of a drug has led to numerous adverse effects. A trial found no preventive effect on symptomatic fractures in men.

    Area of Science:

    • Pharmacovigilance
    • Clinical Trials
    • Orthopedics

    Background:

    • Post-market surveillance has identified a growing number of adverse events associated with a specific drug.
    • Concerns regarding the drug's safety profile have been raised due to the severity and frequency of reported side effects.

    Purpose of the Study:

    • To evaluate the efficacy of the drug in preventing symptomatic fractures.
    • To assess the safety and adverse effects reported since the drug's market release.

    Main Methods:

    • A clinical trial was conducted with 261 male participants.
    • Data on adverse effects and fracture incidence were collected and analyzed.

    Main Results:

    • The study found no evidence that the drug prevents symptomatic fractures.
    • Numerous and potentially serious adverse effects were reported, indicating significant safety concerns.

    Conclusions:

    • The drug demonstrated a lack of preventive effect on symptomatic fractures in the studied population.
    • The findings highlight significant safety issues and adverse effects associated with the drug, warranting further investigation and potential regulatory action.

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