Status: Planned
First registered on:
01/12/2020
Last updated on:
09/12/2020
1. Study identification
EU PAS Register NumberEUPAS38362
Official titleThe risk of musculoskeletal adverse outcomes after treatment with endocrine blocking treatments for breast cancer
Study title acronymMSK_AI
Study typeObservational study
Brief description of the studyTo evaluate the comparative risk of musculoskeletal side effects following treatment with tamoxifen versus aromatase inhibitors
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
Centre nameNDORMS
Centre locationUniversity of Oxford
Details of (Primary) lead investigator
Title Miss
Last name Jennifer
First name Lane
Is this study being carried out with the collaboration of a research network?
Yes
OHDSI (EHDEN)
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?3
IDIAPJGol, Spain
NDORMS, University of Oxford, UK
Countries in which this study is being conducted
International study
Germany
Spain
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/11/2020
Start date of data collection14/12/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report01/07/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
CharitiesMRC, NIHR, Versus Arthritis100
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Miss
Last name Jennifer
First name Lane
Address line 1Botnar research centre
Address line 2NDORMS
Address line 3Windmill Road
CityOxford
PostcodeOX3 7LD
CountryUnited Kingdom
Phone number (incl. country code)441865223725
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Miss
Last name Jennifer
First name Lane
Address line 1Botnar research centre
Address line 2NDORMS
Address line 3Windmill Road
CityOxford
PostcodeOX3 7LD
CountryUnited Kingdom
Phone number (incl. country code)441865223725
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)L02BA01 (tamoxifen)
Substance class (ATC Code)L02BG06 (exemestane)
Substance class (ATC Code)L02BG04 (letrozole)
Substance class (ATC Code)L02BG03 (anastrozole)
Substance class (ATC Code)L02BG05 (vorozole)
7. Medical conditions to be studied
Medical condition(s)Yes
Breast cancer female
Additional Medical Condition(s)
Osteoarthritis, Carpal tunnel syndrome, tendinopathy
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 subjects500000
Additional information
to be confirmed once study design run in datasets
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
IQVIA disease analyser, Germany
IQVIA US LRxDx open claims, United States
Sources of data
Administrative database, e.g. claims database
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
The aim of this study is to assess the comparative risk of musculoskeletal adverse events in post menopausal women taking of tamoxifen (TMX) versus Aromatase Inhibitors (AI) used in the treatment of breast cancer.
Are there primary outcomes?Yes
comparative risk of developing carpal tunnel syndrome, osteoarthritis and tendinopathies
Are there secondary outcomes?Yes
If sufficiently powered, this study aims to assess the comparative risk of musculoskeletal adverse events in those taking non-steroidal AIs (NSAIs) versus steroidal AIs (SAIs)
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Cohort exit is defined by the end of observation, death, or occurrence of a specified outcome, each outcome considered within an individual analysis.
Two periods of follow-up will be considered: In an intention-to-treat analysis, and an on-treatment analysis
15. Data analysis plan
Please provide a brief summary of the analysis method
New user design within a comparative cohort analysis of tamoxifen versus aromatase inhibitors, with the hazards of outcome during the follow-up periods compared using a univariate Cox proportional hazards model conditioned on the PS adjustment with treatment allocation as the sole explanatory variable
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
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
