Study identification

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

Contact details

Erica Voss

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Janssen Research & Development, LLC.
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable