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  <docDscr>
    <citation>
      <titlStmt>
        <titl>
Vertebral fractures after Denosumab discontinuation</titl>
        <IDNo agency="DOI System">
10.16909-DATASET-24        </IDNo>
      </titlStmt>
      <rspStmt>
        <othId role="Metadata and DDI creator" affiliation="Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland">
            Racine, Céline
        </othId>
      </rspStmt>
      <prodStmt>
        <producer abbr="Unisanté" role="Data publisher">
Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland</producer>
        <software version="7.5.7">
          Notepad++
        </software>
      </prodStmt>
      <verStmt>
        <version>
          Version 1.0 (December 2020)
        </version>
      </verStmt>
    </citation>
  </docDscr>
  <stdyDscr>
    <citation>
      <titlStmt>
        <titl>
Vertebral fractures after Denosumab discontinuation</titl>

        <subTitl>
A retrospective study of 797 cases</subTitl>
        <IDNo agency="DOI System">
10.16909-DATASET-24</IDNo>
      </titlStmt>
      <rspStmt>
        <AuthEnty affiliation="Clinic Bois Cerf/Hirslanden, Lausanne, Switzerland">
         Burckhardt, Peter
        </AuthEnty>
<AuthEnty affiliation="Center for Primary Care and Public Health (Unisanté), Department of education, research and innovation (DFRI)">
         Faouzi, Mohamed 
        </AuthEnty>

		<othId role="Creation of questionnaire" affiliation="Center for Primary Care and Public Health (Unisanté)">
<p>Perriraz, Margot</p>
        </othId>
      </rspStmt>
      <prodStmt>
<producer affiliation="Bois Cerf/Hirslanden, Lausanne, Switzerland" role="First author">
Burckhardt, Peter
        </producer>
		<producer affiliation="Center for Primary Care and Public Health (Unisanté), Department of education, research and innovation (DFRI)" role="Main co-author, statistician">
Faouzi, Mohamed 
        </producer>
		<producer affiliation="University Hosp. CHUV, Lausanne, Switzerland" role="Main co-author">
Lamy, Olivier 
        </producer>
		<producer affiliation="Clin. Pharmacology, University Hospital CHUV, Lausanne" role="Main co-author">
Buclin, Thierry 
        </producer>
        <copyright>
          (c) 2020, Peter Burckhardt and Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland
        </copyright>

        <fundAg abbr="Amgen Inc.">
          Amgen Inc.
        </fundAg>

      </prodStmt>
      <verStmt>
        <version date="2020-12-16">
          Version 1.0
        </version>
      </verStmt>
    </citation>
    <stdyInfo>
      <subject>
        <keyword>
Osteoporosis</keyword>
<keyword>
fracture risk assessment</keyword>
<keyword>
statistical methods</keyword>
<keyword>
antiresorptives</keyword>
<keyword>
denosumab</keyword>
       
      </subject>
      <abstract>
        <![CDATA[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. ]]>
      </abstract>
      <sumDscr>
        <collDate date="2019-01-17" event="start"/>
        <collDate date="2019-11-15" event="end"/>
        <nation abbr="CHE">
          Switzerland
        </nation>
        <geogCover>
Switzerland</geogCover>
        <anlyUnit>
834 female patients</anlyUnit>
<dataKind><![CDATA[Retrospective analysis of clinical data collected by questionnaire]]>
</dataKind>
      </sumDscr>
    </stdyInfo>
	    <method>
      <dataColl>
        <sampProc>
          <![CDATA[Data Collection by an electronic questionnaire. with min. 155 items]]>
        </sampProc>
		<collMode>
collection of questionnaires</collMode>
        <resInstru>
          <![CDATA[questionnaire – statistical analysis of the data
]]>
        </resInstru>
		<cleanOps>review of the questionnaires – completion on missing data – exclusion of insufficient data
		</cleanOps>
		</dataColl>
		</method>
    <dataAccs>
      <useStmt>
        <confDec>

        </confDec>
		<contact affiliation="Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland" email="dfri.data@unisante.ch">
          Racine, Céline (Repository manager)
        </contact>
        <citReq>
         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 (Unisanté), University of Lausanne, Switzerland. Version 1.0 of the licensed dataset (December 2020), provided by the Unisanté Research Data Repository. DOI:10.16909/DATASET/24
        </citReq>
    
        <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.
        </disclaimer>
      </useStmt>
    </dataAccs>
  </stdyDscr>
  <dataDscr/>
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