title: The prevention of postmenopausal osteoporotic fractures: results of the Health Technology Assessment of a new antiosteoporotic drug.
abstract: OBJECTIVE
  The Health Technology Assessment (HTA) approach was applied to denosumab in the prevention of osteoporotic fractures in postmenopausal women.
  
  
  METHODS
  Epidemiological, clinical, technical, economic, organizational, and ethical aspects were considered. Medical electronic databases were accessed to evaluate osteoporosis epidemiology and therapeutical approaches. A budget impact and a cost-effectiveness analyses were performed to assess economic implications. Clinical benefits and patient needs were considered with respect to organizational and ethical evaluation.
  
  
  RESULTS
  In Italy around four millions women are affected by osteoporosis and have a higher risk for fractures with 70,000 women being hospitalized every year. Bisphosphonates and strontium ranelate are recommended as first line treatment for the prevention of osteoporotic fractures. Denosumab is effective in reducing vertebral, nonvertebral, and hip/femoral fractures with an advantage of being administered subcutaneously every six months. The budget impact analysis estimated a reduction in costs for the National Health Service with the introduction of denosumab. Furthermore, the economic analysis demonstrated that denosumab is cost-effective in comparison to oral bisphosphonates and strontium ranelate. Denosumab can be administered in outpatients by involving General Practitioners in the management. Ethical evaluation is positive because of its efficacy and compliance.
  
  
  CONCLUSIONS
  Denosumab could add value in the prevention of osteoporotic fractures.
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Chiara
authors.identifier: 0000-0002-4346-1494
authors.initials: C
authors.lastname: de Waure
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Maria Lucia
authors.identifier: 0000-0002-3859-4591
authors.initials: ML
authors.lastname: Specchia
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Chiara
authors.identifier: 0000-0003-0149-1078
authors.initials: C
authors.lastname: Cadeddu
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Capizzi
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Stefano
authors.identifier: 0000-0003-4633-4420
authors.initials: S
authors.lastname: Capri
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Di Pietro
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Maria Assunta
authors.initials: MA
authors.lastname: Veneziano
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Maria Rosaria
authors.identifier: 0000-0001-7357-2892
authors.initials: MR
authors.lastname: Gualano
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Flavia
authors.identifier: 0000-0002-5756-0776
authors.initials: F
authors.lastname: Kheiraoui
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: La Torre
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Nicolotti
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Sferrazza
authors.affiliation: Research Centre for Health Technology Assessment, Department of Public Health, Section of Hygiene, Universitá Cattolica del Sacro Cuore, Largo F. Vito 1, 00168 Rome, Italy.
authors.forename: Walter
authors.identifier: 0000-0002-5655-688X
authors.initials: W
authors.lastname: Ricciardi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000191:economics / Q000627:therapeutic use*; D050071:Bone Density Conservation Agents / Q000191:economics / Q000627:therapeutic use*; D002017:Budgets; D003362:Cost-Benefit Analysis; D000069448:Denosumab; D005260:Female; D006760:Hospitalization / Q000191:economics; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008390:Markov Chains; D008875:Middle Aged; D058866:Osteoporotic Fractures / Q000188:drug therapy* / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control*; D017698:Postmenopause / Q000187:drug effects; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000941:ethics / Q000458:organization & administration; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D050071:Bone Density Conservation Agents; D000069448:Denosumab