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Safety profile of drugs used in the treatment of osteoporosis: a systematical review of the literature

M. Varenna, F. Bertoldo, M. Di Monaco, A. Giusti, G. Martini, M. Rossini, On behalf of SIOMMMS, Endorsed by SIR
  • M. Varenna
    Bone Diseases Unit, Department of Rheumatology, Gaetano Pini Institute, Milan, Italy |
  • F. Bertoldo
    Department of Biomedical and Surgical Sciences, Unit of Diseases of Mineral Metabolism and the Bone, University of Verona, Verona, Italy
  • M. Di Monaco
    Osteoporosis Research Center, Division of Physical Medicine and Rehabilitation, San Camillo Hospital, Torino, Italy
  • A. Giusti
    Bone Clinic, Department of Geriatrics and Musculoskeletal Sciences, E.O. Galliera Hospital, Genova, Italy
  • G. Martini
    Department of Medical, Surgical and Neurological Sciences University of Siena, Siena, Italy
  • M. Rossini
    Rheumatology Section, Department of Medicine, University of Verona, Verona, Italy
  • On behalf of SIOMMMS
    Affiliation not present
  • Endorsed by SIR
    Affiliation not present


The range of osteoporosis treatments is increasingly large and, like any disease, the pharmacological management of patients should involve a risk/benefit evaluation to attain the greatest reduction in risk of fracture with the lowest incidence of adverse events. The aim of this review is to critically appraise the literature about the safety issues of the main pharmacological treatments of osteoporosis. This document is the result of a consensus of experts based on a systematic review of regulatory documents, randomized controlled trials, metaanalyses, pharmacovigilance surveys and case series related to possible adverse drug reactions to osteoporosis treatment with calcium and vitamin D supplements, bisphosphonates, strontium ranelate, selective estrogen receptor modulators, denosumab, and teriparatide. As expected, randomized controlled trials showed only the most common adverse events due to the samples size and the short observation time. Case series and observational studies are able to provide data about uncommon side effects, but in some cases a sure cause-effect relationship needs still to be confirmed. Consistently with methodological limitations, the newer drugs have a tolerance profile that has not been fully explored yet. Osteoporosis treatments showed an overall good tolerance profile with rare serious adverse events that, however, must be well known by the clinician who prescribes these drugs. The concern about possible adverse events should be weighed against the reduction of morbidity and mortality associated with a significant fracture risk reduction.


Osteoporosis, Treatment, Pharmacology, Side effects.

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Submitted: 2013-07-26 11:01:05
Published: 2013-10-31 14:37:37
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Copyright (c) 2013 M. Varenna, F. Bertoldo, M. Di Monaco, A. Giusti, G. Martini, M. Rossini, On behalf of SIOMMMS, Endorsed by SIR

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