{"doc_desc":{"title":"Vertebral fractures after Denosumab discontinuation","idno":"10.16909-DATASET-24","producers":[{"name":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","abbreviation":"Unisant\u00e9","affiliation":"","role":"Data publisher"}],"version_statement":{"version":"Version 1.0 (December 2020)"}},"study_desc":{"title_statement":{"idno":"10.16909-DATASET-24","title":"Vertebral fractures after Denosumab discontinuation","sub_title":"A retrospective study of 797 cases"},"authoring_entity":[{"name":"Burckhardt, Peter","affiliation":"Clinic Bois Cerf\/Hirslanden, Lausanne, Switzerland"},{"name":"Faouzi, Mohamed","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), Department of education, research and innovation (DFRI)"}],"oth_id":[{"name":"Perriraz, Margot","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9)","email":"","role":"Creation of questionnaire"}],"production_statement":{"producers":[{"name":"Burckhardt, Peter","affiliation":"Bois Cerf\/Hirslanden, Lausanne, Switzerland","role":"First author"},{"name":"Faouzi, Mohamed","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), Department of education, research and innovation (DFRI)","role":"Main co-author, statistician"},{"name":"Lamy, Olivier","affiliation":"University Hosp. CHUV, Lausanne, Switzerland","role":"Main co-author"},{"name":"Buclin, Thierry","affiliation":"Clin. Pharmacology, University Hospital CHUV, Lausanne","role":"Main co-author"}],"copyright":"(c) 2020, Peter Burckhardt and Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","funding_agencies":[{"name":"Amgen Inc.","abbreviation":"Amgen Inc.","role":""}]},"version_statement":{"version":"Version 1.0","version_date":"2020-12-16"},"study_info":{"keywords":[{"keyword":"Osteoporosis","vocab":"","uri":""},{"keyword":"fracture risk assessment","vocab":"","uri":""},{"keyword":"statistical methods","vocab":"","uri":""},{"keyword":"antiresorptives","vocab":"","uri":""},{"keyword":"denosumab","vocab":"","uri":""}],"abstract":"A rebound of osteoclast activity during the 2 years after a treatment or prevention of osteoporosis with denosumab (Dmab) leads to an increased risk of vertebral fractures (VF).  We attempted to identify the risk factors for these VF and to examine the protective role of bisphosphonates. For that, 22 specialists in Switzerland provided data of unselected patients, treated with denosumab for osteoporosis or breast cancer without metastases under aromatase inhibitors, who have received at least 2 injections of Dmab, with at least 1 year of follow-up after discontinuation. The questionnaire covered separately the periods before, during and after Dmab treatment, and registered clinical, radiological and lab data. For the analysis of the risk factors, the main outcomes were: the time to the first VF after the treatment, the presence of multiple VFs (MVFs), and the number of VFs. The incidence of VF was 16.4% before, 2.2% during and 10.3% after the treatment with Dmab. The risk of VF after Dmab discontinuation was associated with an increased risk of non-vertebral fractures. The pre-treatment predictors of the post-treatment fracture risk were a parental hip fracture and previous VFs. Further risk factures appeared later, such as low total hip BMD during and after denosumab, increased bone resorption markers and the loss of total hip BMD after the denosumab. Treatment with bisphosphonates, especially after Dmab, had a protective effect. Bisphosphonates given before Dmab did not further decrease the risk of VF in cases who got bisphosphonates after Dmab. This study shows that the risk of VF is poorly predictable before the prescription of denosumab. But during and after the treatment, bone resorption markers and BMD have a significant predictive value. Bisphosphonates after the treatment with denosumab are protective against VFs.","coll_dates":[{"start":"2019-01-17","end":"2019-11-15","cycle":""}],"nation":[{"name":"Switzerland","abbreviation":"CHE"}],"geog_coverage":"Switzerland","analysis_unit":"834 female patients","data_kind":"Retrospective analysis of clinical data collected by questionnaire"},"method":{"data_collection":{"sampling_procedure":"Data Collection by an electronic questionnaire. with min. 155 items","coll_mode":"collection of questionnaires","research_instrument":"questionnaire \u2013 statistical analysis of the data","cleaning_operations":"review of the questionnaires \u2013 completion on missing data \u2013 exclusion of insufficient data"}},"data_access":{"dataset_use":{"conf_dec":[{"txt":"","required":"","form_no":"","uri":""}],"contact":[{"name":"Racine, C\u00e9line (Repository manager)","affiliation":"Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland","email":"dfri.data@unisante.ch","uri":""}],"cit_req":"Burckhardt P, Buclin T, Faouzi M, Lamy O. Vertebral fractures after Denosumab discontinuation. A retrospective study of 797 cases.  Center for Primary Care and Public Health (Unisant\u00e9), University of Lausanne, Switzerland. Version 1.0 of the licensed dataset (December 2020), provided by the Unisant\u00e9 Research Data Repository. DOI:10.16909\/DATASET\/24","disclaimer":"The user of the data acknowledges that the original collector of the data, the authorized distributor of the data, and the relevant funding agency bear no responsibility for use of the data or for interpretations or inferences based upon such uses."}}},"schematype":"survey"}