Postmarketing Surveillance Study of EVENITY (Romosozumab) in South Korea (20170753)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Safety Reporting

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, observational study

Study drug and medical condition

• Name of medicine:
  EVENITY
• Study drug International non-proprietary name (INN) or common name:
  ROMOSOZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (M05BX06) romosozumab

  romosozumab
• Medical condition to be studied:
  Osteoporosis

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The primary objective of this study is to estimate the incidence rates of adverse events, serious adverse events, and adverse drug reactions among patients receiving EVENITY on label in the post-marketing setting in South Korea as required by the MFDS.
• Outcomes:
  Incidence of adverse events, serious adverse events, and adverse drug reactions, Treatment response as determined by percent change from baseline in BMD (measured by DXA) of the lumbar spine and/or total hip and/or femoral neck at 12 months (or as close as possible to the last dose of EVENITY) per local standard of care.
• Data analysis plan:
  Given the observational nature of the study, data will be summarized descriptively. The Safety Analysis Set will include all patients who received at least 1 dose of EVENITY and have at least 1 follow-up. ; The incidence of adverse events will be summarized to include all treatment-emergent adverse events recorded from the start of EVENITY on this study or any worsening of medical conditions initially experienced before initiation of this study. ; This summary for adverse events will be performed for the following categories: ; • All adverse events and adverse drug reactions ; • Serious adverse events and serious adverse drug reactions; • Adverse events leading to EVENITY discontinuation; • Fatal events