Periodic Knowledge, Attitudes, and Behavior (KAB) Survey of Certified Prescribers to Assess Understanding of the Risks with the Prolia Risk Evaluation and Mitigation of Strategy (REMS) (20240121)

Study type

• Study topic:
  Other
• Study topic, other:
  US-based, observational, cross-sectional survey of HCPs who are currently prescribing and those who have the potential to prescribe Prolia
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Survey

Study drug and medical condition

• Name of medicine:
  PROLIA
• Study drug International non-proprietary name (INN) or common name:
  DENOSUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (M05BX04) denosumab

  denosumab
• Medical condition to be studied:
  Chronic kidney disease

Population studied

• Short description of the study population:
  HCPs who are currently prescribing and have the potential to prescribe Prolia
• Age groups:
  Adult and elderly population (≥18 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Healthcare providers
• Estimated number of subjects:
  371

Study design details

• Study design:
  The objectives of this study are to conduct a survey with HCPs who are currently or have the potential to prescribe Prolia, 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.
• Main study objective:
  To describe HCP knowledge of:; - The risk of severe hypocalcemia in patients with advanced CKD; - The need to assess for presence of CKD-MBD before initiating Prolia
• Setting:
  Online survey
• Comparators:
  None
• Outcomes:
  The objectives of the HCP KAB survey are to conduct a survey with HCPs identified via Amgen’s database, who are known to be prescribing 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 risks of Prolia, the Prolia REMS; requirements, and the REMS goals and materials:; • Key Risk Message 1: HCPs must understand the risk of severe hypocalcemia in patients with advanced CKD.; • Key Risk Message 2: HCPs must understand the need to assess for presence of CKD-MBD before initiating Prolia.
• Data analysis plan:
  Statistical analyses will be descriptive in nature. Counts and percentages will be calculated for each question/item in the questionnaire. Ninety-five percent (95%) CIs for the survey end points will be calculated to provide an estimate of precision; however no formal hypothesis will be tested. All CIs around the percentages will be exact binomial; 2-sided 95% CIs calculated according to the method of Clopper-Pearson. Analyses will be performed at the respondent level; therefore, within-respondent variation is not relevant.