Created on : 16.12.2020 Last modified : 04.01.2021

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

Switzerland, 2019

Reference ID

10.16909-DATASET-24

DOI

https://doi.org/10.16909/DATASET/24

Producer(s)

Burckhardt, Peter, Faouzi, Mohamed

Collections

Department of epidemiology and health systems (DESS)

Metadata

DDI/XML JSON

Identification

Survey ID number

10.16909-DATASET-24

Title

Vertebral fractures after Denosumab discontinuation

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:

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

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
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

Survey instrument

Questionnaires

questionnaire – statistical analysis of the data

Data collection

Dates of Data Collection

Start	End
2019-01-17	2019-11-15

Data processing

Data Editing

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

Data Access

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

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

Disclaimer and copyrights

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.

Metadata production

DDI Document ID

10.16909-DATASET-24

Producers

Name	Role
Center for Primary Care and Public Health (Unisanté), University of Lausanne, Switzerland	Data publisher

Metadata version

DDI Document version

Version 1.0 (December 2020)

Study description in PDF

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