Effect of Denosumab on Patients with Osteoporosis

About the Drug:

Denosumab is a medication developed to inhibit the action of active bone-resorbing cells. Unlike bisphosphonates, Denosumab reduces the production of bone-resorbing cells without affecting the function of mature cells. The drug does not accumulate in bone tissue and its effect ceases after treatment. It is safe in cases of renal dysfunction.
Denosumab is available in a pen injection format, administered subcutaneously every six months.

Treatment safety is questionable ❗️

Swiss doctors express concern about a serious side effect of Denosumab, showing an unexpected inverse effect after treatment cessation, manifested by increased bone pain and risk of vertebral fractures.
Doubts about treatment safety have increased since 2015, as Denosumab has been linked to bone pain and an increased risk of sudden vertebral fractures after treatment discontinuation.
After discontinuation of the drug, an increase in bone remodeling markers and a rapid decrease in bone density are observed.

  • Study results show that bone resorption resumes rapidly after Denosumab discontinuation, with activity doubling within 12 months after the last injection.
  • Swissmedic, the Swiss drug regulatory authority, continues to investigate the safety of this treatment, leading to the modification of Prolia drug usage instructions in 2017.
    Comments from Various Parties
  • Amgen declined to comment to journalists, with company representatives stating that the increased fracture risk after treatment cessation came as a big surprise to them. This raises the question: how could this happen, especially since the drug is designed to combat osteoporosis and is administered only once every six months.
    On the contrary, clinical pharmacology experts have a completely different opinion. Professor Thierry Buclin from the University of Lausanne points out that this is reminiscent of the controversial history of the diabetes drug Mediator, which was used by diabetic patients as a weight-loss aid. The drug was used for a long period in France, despite repeated observations of damage to heart valves during treatment. After a long struggle, it was revealed that the main component of Mediator belongs to the group of amphetamines, which are potent nervous system stimulants, explaining many adverse reactions, including its effect on the heart.
    Swiss doctors hope that Amgen takes matters seriously and conducts further studies on the safety of the treatment.


  • Olivier Lamy, Elena Gonzalez-Rodriguez, Delphine Stoll, Bérengère Aubry-Rozier. Rev Med Suisse 2017; volume 13. 863-866.
  • Juliette Galeazzi. L’ostéoporose au coeur d’un scandale découvert à Lausanne. www.rts.ch