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Denosumab for menopausal and cancer-related bone loss


Hans-Peter Lipp PharmD, PhD

Chief Pharmacist

University Hospital Tubingen



Postmenopausal osteoporosis (PMO) has been classified as an important risk factor for the development of vertebral and non-vertebral fractures. As a consequence, optimal prevention and treatment of this disease is of great pharmaco-economic value. Undoubtedly, oral bisphosphonates represent the treatment of first choice in this context (Table 1); however, the importance of non-adherence among elderly patients may be underestimated.1,2 

More dramatic courses of bone loss have been described in cancer patients with metastatic disease based on rapidly progressing osteolytic lesions with severe bone pain, pathologic fractures, compression syndromes and electrolyte disorders (eg. hypercalcaemia) as a consequence. Similarly to their use in treatment of PMO, bisphosphonates are classified as first-line agents in the treatment of tumour-associated bone loss; however, more intensified dose regimens have been associated with an increased risk for acute phase reactions, need for dose modification in patients with renal dysfunction and osteonecrosis of the jaw (ONJ).1,2,3,4 Despite the established role of bisphosphonates in treatment of PMO and bone metastases, there is an unmet need for further optimisation. 



Denosumab represents an encouraging new option for PMO treatment as well as oncological indications based on its novel mechanism of action, impressive spectrum of clinical trial results and very good tolerability.1,2,3 The drug has been approved by the European Medical Agency (EMA) for PMO treatment and adjuvant use in prostate cancer (Prolia 60 mg

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