Study identification

EU PAS number

EUPAS18916

Study ID

41269

Official title and acronym

Prospective Observational Study to Describe Characteristics and Management of Patients With Osteoporosis Treated With Prolia® in Routine Clinical Practice in Poland (20160178)

DARWIN EU® study

No

Study countries

Poland

Study description

This is a multi-center, one country, non-interventional, prospective, observational study in osteoporosis patients population who received at least one injection of Prolia® 60 mg Q6M, SC (subcutaneous) in Poland. Prolia® naive patients will be eligible to enroll within 8 weeks after initiation of Prolia® treatment. It is expected that patients will receive their scheduled Prolia® injection every 6 months as part of their routine clinical care. The estimated duration of enrollment is 12 months. No study drug will be administered as part of the study. It is anticipated that patients will return to the clinic every 6 months to receive their Prolia® prescription and/or injections. After the initial visit, information regarding Prolia® prescription and administration, procedures pertaining to osteoporosis and Prolia®, concomitant medication use, and non-serious and serious AEs will be collected during routine clinical visits and recorded for up to approximately 12 months after entering the study.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution
Multiple centres: 20 centres are involved in the study

Contact details

Biotechnologia Sp. z o.o. 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
Regulatory

Was the study required by a regulatory body?

No

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

Non-EU RMP only