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Vertebral fractures after Denosumab discontinuation, A retrospective study of 797 cases

Switzerland, 2019
Department of education, research and innovation (DFRI)
Burckhardt, Peter, Faouzi, Mohamed
Created on December 16, 2020 Last modified January 04, 2021 Page views 2367 Documentation in PDF Metadata DDI/XML JSON

Identification

Survey ID Number
10.16909-DATASET-24
Title
Vertebral fractures after Denosumab discontinuation, A retrospective study of 797 cases
Subtitle
A retrospective study of 797 cases
Country
Name Country code
Switzerland CHE
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.
Kind of Data
Retrospective analysis of clinical data collected by questionnaire
Unit of Analysis
834 female patients

Version

Version Description
Version 1.0
Version Date
2020-12-16

Scope

Keywords
Keyword
Osteoporosis
fracture risk assessment
statistical methods
antiresorptives
denosumab

Coverage

Geographic Coverage
Switzerland

Producers and sponsors

Primary investigators
Name Affiliation
Burckhardt, Peter Clinic Bois Cerf/Hirslanden, Lausanne, Switzerland
Faouzi, Mohamed Center for Primary Care and Public Health (Unisanté), Department of education, research and innovation (DFRI)
Producers
Name Affiliation Role
Burckhardt, Peter Bois Cerf/Hirslanden, Lausanne, Switzerland First author
Faouzi, Mohamed Center for Primary Care and Public Health (Unisanté), Department of education, research and innovation (DFRI) Main co-author, statistician
Lamy, Olivier University Hosp. CHUV, Lausanne, Switzerland Main co-author
Buclin, Thierry Clin. Pharmacology, University Hospital CHUV, Lausanne Main co-author
Funding Agency/Sponsor
Name Abbreviation
Amgen Inc. Amgen Inc.
Other Identifications/Acknowledgments
Name Affiliation Role
Perriraz, Margot Center for Primary Care and Public Health (Unisanté) Creation of questionnaire

Sampling

Sampling Procedure
Data Collection by an electronic questionnaire. with min. 155 items

Data Collection

Dates of Data Collection
Start End
2019-01-17 2019-11-15
Data Collection Mode
collection of questionnaires

Questionnaires

Questionnaires
questionnaire – statistical analysis of the data

Data Processing

Data Editing
review of the questionnaires – completion on missing data – exclusion of insufficient data

Access policy

Access authority
Name Affiliation Email
Racine, Céline (Repository manager) Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland dfri.data@unisante.ch
Confidentiality
Citation requirements
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

Metadata production

DDI Document ID
10.16909-DATASET-24
Producers
Name Abbreviation Role
Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland Unisanté Data publisher
DDI Document version
Version 1.0 (December 2020)