Safety issues and adverse reactions with osteoporosis management

ABSTRACT

Introduction: Osteoporosis is a disease that has spread worldwide and has become a relevant public health problem. Over the last 2 decades, a number of drugs have been licensed for its treatment owing to their efficacy in preventing fragility fractures. The safety profiles of these drugs are well defined with data from extensive programs of pharmacovigilance to support it.

Areas covered: In this article we reviewed the long-term safety of Bisphosphonates, Calcium, Vitamin D, Selective Estrogen Receptor Modulators, Teriparatide and Denosumab. We excluded hormone replacement therapy that lost its indication for the treatment of osteoporosis. The license for the treatment of osteoporosis of Calcitonin was recently withdrawn and that of Strontium ranelate was severely limited. For both drugs, we report EMA statements about their safety profile.

Expert opinion: The safety profile of most available drugs for the treatment of osteoporosis is well defined and the most serious adverse events are either rare or predictable. Osteoporosis treatment is a favorable choice in patients at moderate-high risk of fracture, while in patients at low risk pharmacological prevention should involve consideration of the balance between the beneficial effects of treatment, the probability of adverse effects and costs.

KEYWORDS:

• Bisphosphonates
• calcium
• vitamin d
• selective estrogen receptor modulators
• teriparatide
• denosumab
• strontium ranelate

Article highlights

• The most commonly used drugs for osteoporosis are antiresorptives while teriparatide use remains limited to patients with severe osteoporosis. The use of other drugs (calcitonin and strontium ranelate) have been strictly limited owing to their poor risk–benefit ratio.

• The major severe side effects of antiresorptives are extremely rare, but they justify an appropriate assessment of risk–benefit ratio.

• Other minor side effects can be dealt with an individual approach.

• In patients at high risk of fracture, the benefits largely outweigh the risks of treatment.

This box summarizes key points contained in the article.

Acknowledgments

The authors thank Vidya Kunnathully and Sara Rossini who provided editorial assistance.

Declaration of Interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.