Excess risk and predictors of fracture/s following bariatric surgery for obese patients in the NHS: a real-world self-controlled case series and cohort study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30510
• EU PAS number:
  EUPAS21907
• Study ID:
  30510
• Official title and acronym:
  Excess risk and predictors of fracture/s following bariatric surgery for obese patients in the NHS: a real-world self-controlled case series and cohort study
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  BACKGROUND: While bariatric surgery is an effective treatment for severe obesity, some research suggests that it might double the risk of bone breaks. However, the data is controversial, and most of the existing studies compare patients undergoing surgery to those not offered such treatments, making the results difficult to interpret. In addition, we do not know which patients who receive bariatric surgery are at highest risk of breaking their bone/s and could be targeted for further bone assessment/s or treatments. The lack of convincing evidence means screening for bone health is not routinely carried out in the NHS.AIMS: We aim to study if there is an increased risk of bone fracture/s following bariatric surgery. In addition, we will look for key factors that can be combined in a risk scoring tool to identify those most likely to suffer such fractures.DESIGN/METHODS: We will use anonymised GP and hospital records to study these associations in real-world clinical practice conditions, and amongst actual NHS patients. According to figures provided by these data sources, >10,900 patients undergoing bariatric surgery for obesity are available for such a study. To avoid the biases mentioned above we will use advanced methods applied in drug and vaccine safety studies (called ‘self-controlled case series’), where the risk of fracture in the periods before and after surgery are compared for each patient.
• Study status:
  Finalised

Research institutions and networks

Institutions

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

United Kingdom

NDORMS, University of Oxford

Oxford University Hospitals NHS Foundation Trust Oxford, London School of Hygiene and Tropical Medicine London

Study timelines

Date when funding contract was signed

Planned: 01/09/2017

Actual: 30/10/2017

Study start date

Planned: 15/10/2017

Actual: 15/01/2018

Data analysis start date

Planned: 15/01/2017

Actual: 02/04/2018

Date of final study report

Planned: 15/06/2019

Actual: 12/07/2019

Sources of funding

Other

More details on funding

NIHR RfPB, University of Oxford

Study protocol

Initial protocol

PB-PG-1215-20017_protocol

Regulatory

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