Study identification

PURI

https://redirect.ema.europa.eu/resource/19310

EU PAS number

EUPAS17909

Study ID

19310

Official title and acronym

The Risk of Esophageal Cancer in Relation to the Treatment and Prevention of Osteoporosis in Women (MK-0217A-352)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This is a 2-phase retrospective database study, using both case-cohort and inception (intention-to-treat) cohort analyses to evaluate any association between oral treatments for osteoporosis and the risk of esophageal cancer in women.

Study status

Finalised
Research institution and networks

Institutions

Merck & Co.
First published:
01/02/2024
Institution

Contact details

Clinical Trials Disclosure Merck Sharp & Dohme Corp.

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Data collection

Actual:

Start date of data analysis

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.
Study protocol
Initial protocol

0217A-352 protocol_final-redaction

English (770.06 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

EU RMP category 3 (required)