The risk of musculoskeletal adverse outcomes after treatment with endocrine blocking treatments for breast cancer (MSKAI)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40382
• EU PAS number:
  EUPAS38362
• Study ID:
  40382
• Official title and acronym:
  The risk of musculoskeletal adverse outcomes after treatment with endocrine blocking treatments for breast cancer (MSKAI)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Spain

  United Kingdom

  United States
• Study description:
  To evaluate the comparative risk of musculoskeletal side effects following treatment with tamoxifen versus aromatase inhibitors
• Study status:
  Ongoing

Research institution and networks

Institutions

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford

United Kingdom

IQVIA

United Kingdom

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

IDIAPJGol Spain, NDORMS, University of Oxford UK

Networks

Observational Health Data Sciences and Informatics (OHDSI) Network

European Health Data Evidence Network (EHDEN)

Netherlands

Study timelines

Date when funding contract was signed

Planned: 02/11/2020

Study start date

Planned: 14/12/2020

Actual: 14/12/2020

Data analysis start date

Actual: 23/03/2020

Date of final study report

Planned: 01/07/2021

Sources of funding

Non for-profit organisation (e.g. charity)

More details on funding

MRC, NIHR, Versus Arthritis

Study protocol

Initial protocol

MSK_AI_Protocol_1.4 for EU PAS

Updated protocol

MSK_AI_Protocol_1.5 for EU PAS

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable