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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/41269
• 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

Multiple centres: 20 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 19/04/2017

Actual: 19/04/2017

Study start date

Planned: 20/10/2017

Actual: 10/07/2017

Data analysis start date

Planned: 31/08/2020

Actual: 03/08/2020

Date of final study report

Planned: 31/01/2021

Actual: 03/02/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Protocol synopsis_20160178_24Oct2016

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only