The Safety and Clinical Effectiveness of Denosumab Among Chinese Men With Osteoporosis – a Real World Study in Taiwan (20210040)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DENOSUMAB
• Medical condition to be studied:
  Osteoporosis

Population studied

• Short description of the study population:
  The study population includes men aged 50 years or older who received at least one dose of Prolia. To ensure that included men who were receiving Prolia for the indication of MOP, all with a history of Paget’s disease or malignancy are excluded.; ; Inclusion Criteria; 1. Men ( ≥ 50 years old) in Taiwan’s Health Insurance Research Database; 2. Receipt of at least 1 administration of denosumab; 3. Complete age and gender information; ; Exclusion Criteria; 1. History of any malignancy within 1 year before initial use of Prolia; 2. History of Paget’s disease within 1 year before initial use of Prolia
• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  16000

Study design details

• Main study objective:
  This real-world study of the clinical practice of Taiwan aims to characterize the safety and evaluate the effectiveness of Prolia among Chinese men with osteoporosis.
• Outcomes:
  Effectiveness outcome: hip fracture, Safety outcomes: osteonecrosis of the jaw, atypical femur fracture, hypocalcemia, Clinical vertebral fracture, Non-vertebral fracture (hip, wrist, forearm, humerus), Major osteoporotic fracture (clinical vertebral, hip, wrist, forearm, humerus)
• Data analysis plan:
  This study includes both a descriptive analysis for safety endpoints and a comparative analysis for effectiveness endpoints.

Documents

Study results

20210040 ORSR Abstract 04May2022_Redacted