Comparing the Estimated Risk of Hip Fracture Among Subjects Exposed to Tramadol as Compared to Subjects Exposed to Codeine (Tramadol vs Codeine)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/48348
• EU PAS number:
  EUPAS36038
• Study ID:
  48348
• Official title and acronym:
  Comparing the Estimated Risk of Hip Fracture Among Subjects Exposed to Tramadol as Compared to Subjects Exposed to Codeine (Tramadol vs Codeine)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Hip fractures greatly impact an individual’s quality of life and carry a high risk of death within 1 year. Tramadol is a commonly used weak opioid for treatment of pain. A recent study by Wei et al. found that risk for hip fractures was higher for new users of tramadol than for new users of codeine or NSAIDs. We were concerned of that study’s design choices because of several limitations such as: A less-than-optimal propensity score adjustment strategy, the absence of negative controls, the failure to address possible differences in the initial doses of tramadol versus codeine, and the fact that the study was done in only one data source limited to one countries data. We propose to do a study to assess hip fracture incidence among users of tramadol versus codeine that will reassess the relationship and address the Wei et al. study limitations. Wei, J., et al., Association of Tramadol Use With Risk of Hip Fracture. J Bone Miner Res, 2020.
• Study status:
  Finalised

Research institutions and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Planned: 19/02/2020

Actual: 19/02/2020

Study start date

Planned: 19/02/2020

Actual: 19/02/2020

Data analysis start date

Planned: 19/02/2020

Actual: 19/02/2020

Date of final study report

Planned: 24/09/2021

Actual: 09/07/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen Research & Development, LLC.

Study protocol

Initial protocol

Protocol - Tramadol vs Codeine and Risk of Hip Fracture

Updated protocol

Protocol - Tramadol vs Codeine and Risk of Hip Fracture - Admendment

Regulatory

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