Study identification

PURI

https://redirect.ema.europa.eu/resource/33874

EU PAS number

EUPAS25381

Study ID

33874

Official title and acronym

Incidence of new Primary Malignancies Among Patients With Bone Metastases From Breast, Prostate, or Lung Cancer Treated With XGEVA or Intravenous Zoledronic Acid: a Retrospective Cohort Study (20170728)

DARWIN EU® study

No

Study countries

United States

Study description

The purpose of this study is to estimate the incidence of any new primary malignancy (any haematologic or non-haematologic tumour, excluding non-melanoma skin cancer subsequent to the first primary malignancy) among patients with breast, prostate, or lung cancer and bone metastases following initiation of either XGEVA or zoledronic acid, and to describe the types of new primary malignancies that patients experience, as well as the characteristics of the patients who develop new primary malignancies. The study employs a retrospective cohort design and data from the SEER-Medicare linked datasets.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc.

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

Amgen, Inc.
Study protocol
Initial protocol
English (703.48 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)