Status: Finalised
First registered on:
22/11/2019
Last updated on:
11/02/2022
1. Study identification
EU PAS Register NumberEUPAS30506
Official titleOsteoporosis outcomes and treatment patterns in France (20190017)
Study title acronym
Study typeObservational study
Brief description of the studyThis is a retrospective cohort study in the National healthcare data system (Système National des Données de Santée - SNDS) containing French nationwide claims and hospital database including postmenopausal women receiving treatment for osteoporosis. The research question is to assess the treatment patterns and the impact of osteoporosis medication on fracture incidence in France. The primary objective is to assess the change in fracture risk after treatment initiation among post-menopausal women receiving osteoporosis treatment, overall and stratified by type of treatment and type of fracture
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Details of (Primary) lead investigator
Title Dr
Last name Bosco-Levy (Prince)
First name Pauline
Is this study being carried out with the collaboration of a research network?
Yes
Bordeaux PharmacoEpi
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed28/06/201928/06/2019
Start date of data collection15/06/202008/10/2020
Start date of data analysis01/08/202023/03/2021
Date of interim report, if expected
Date of final study report31/12/202108/12/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAmgen100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Amgen Inc.
First name Global Development Leader
Address line 1One Amgen Center Drive
Address line 2
Address line 3
CityThousand Oaks, CA
Postcode91320-1799
CountryUnited States
Phone number (incl. country code)18054473505
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Amgen Inc.
First name Global Development Leader
Address line 1One Amgen Center Drive
Address line 2
Address line 3
CityThousand Oaks, CA
Postcode91320-1799
CountryUnited States
Phone number (incl. country code)18054473505
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)M05BX04 (denosumab)
7. Medical conditions to be studied
Medical condition(s)Yes
Osteoporosis
8. Population under study
Age
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Female
9. Number of subjects
Estimated total number of subjects2000000
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
National healthcare insurance and hospital-discharge summary database (SNIIRAM database), France
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Effectiveness evaluation
Primary scope : Effectiveness evaluation
12. Main objective(s)
What is the main objective of the study?
To assess the treatment patterns and the impact of osteoporosis medication on fracture incidence in France
Are there primary outcomes?Yes
To assess the change in fracture risk after treatment initiation among post-menopausal women receiving osteoporosis treatment, overall and stratified by type treatment and type of fracture
Are there secondary outcomes?Yes
• To describe osteoporosis treatment patterns among post-menopausal women receiving osteoporosis treatment;
• To describe characteristics of post-menopausal women receiving osteoporosis treatment;
• To assess the change in fracture risk after treatment discontinuation among post-menopausal women receiving osteoporosis treatment, overall and stratified by type treatment and type of fracture
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
• Flow chart for population selection
• Description of baseline characteristics
• Description of drug use by duration of treatment, discontinuation, switching and adherence
• Description of the fracture outcome as the unadjusted risk and rate
• Fracture incidence rate assessed during three periods:
1. Early treatment period (first 3 months post-index, which assumes a delay in fracture reduction following treatment initiation)
2. Treatment exposure period (subsequent time on treatment after the first 3-months post-index, until end of follow up or treatment discontinuation)
3. Post-discontinuation period (period of time with no treatment after treatment discontinuation)
• Fracture incidence rates will be compared between the early treatment period and the treatment exposure period using incidence rate ratios using an own-control analysis
• Fracture incidence rate in the post-discontinuation period will be compared with the early treatment period and treatment exposure period
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
Bosco-Lévy P, O’Kelly J, Briot K, Mehsen-Cetre N, Fabre A, Lassalle R, et al. Efficacité en vie réelle des traitements de l’ostéoporose sur le risque de fracture : une étude de cohorte en population française. Revue du Rhumatisme. 2021 Dec;88:A13–4.
DOI: 10.1016/j.rhum.2021.10.019https://linkinghub.elsevier.com/retrieve/pii/S1169833021002787
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
