Periodic Knowledge Assessment Survey of Healthcare Providers (HCPs) to Assess Understanding of the Risks with the Prolia® Risk Evaluation and Mitigation Strategy (REMS)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000393
• Study ID:
  1000000393
• Official title and acronym:
  Periodic Knowledge Assessment Survey of Healthcare Providers (HCPs) to Assess Understanding of the Risks with the Prolia® Risk Evaluation and Mitigation Strategy (REMS)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will be conducted to survey HCPs who are currently prescribing and those who have the potential to prescribe Prolia, who are part of the REMS Communication Plan outreach, and who have not been debarred or sanctioned in order to assess their awareness and understanding of the risk of severe hypocalcemia with Prolia, the Prolia REMS requirements, and the REMS goals and materials.;
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Actual:18/09/2024

Study start date

Actual:07/04/2025

Date of final study report

Planned:03/05/2031

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

20240121