A Real-world, Prospective, Observational Study of Prolia® (20180401)

Study identification

• EU PAS number:
  EUPAS37579
• Study ID:
  105188
• Official title and acronym:
  A Real-world, Prospective, Observational Study of Prolia® (20180401)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study description:
  This is a real-world, prospective, single arm, observational multi-center study. At least 3000 women with postmenopausal osteoporosis (PMO) who are being prescribed Prolia® will be enrolled. The planned study period is 3 years. Information will be collected to evaluate the safety and effectiveness of Prolia® in a post-marketing setting in China. All data collected for this study will be extracted from the information generated or gathered through routine medical practice.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 19/08/2020

Study start date

Planned: 31/05/2023

Actual: 22/05/2023

Data analysis start date

Planned: 30/06/2024

Actual: 01/07/2024

Date of interim report, if expected

Planned: 31/07/2024

Date of final study report

Planned: 30/12/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

Protocol number - 20180401