The Safety and Effectiveness of Denosumab Among Chinese With Osteoporosis and Glucocorticoid Exposure – a Real World Study in Taiwan (20220054)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• 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

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

Study drug and medical condition

• Name of medicine:
  PROLIA
• Medical condition to be studied:
  Osteoporosis

Population studied

• Short description of the study population:
  The study population comprised of male and female patients aged 18 years or older diagnosed with osteoporosis received treatment with Prolia between 2012 to 2019 identified from the health insurance research database (HIRD) and Chang Gung Research Database (CGRD) of Taiwan.; Inclusion criteria:; 1. Eligible patients included all men and women 18 years of age or older who has received their first administration of Prolia between 2012 and 2019 and had at least 2 glucocorticoid prescriptions during their first Prolia dose course.; ; Exclusion criteria:; 1. Patients excluded from the study if they had a history of malignancy or Paget's disease with 1 year before initial use of Prolia.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Osteoporosis patients
• Estimated number of subjects:
  36000

Study design details

• Main study objective:
  The main objective of this study is to characterize the safety of denosumab among Chinese participants with osteoporosis and glucocorticoid exposure, and to evaluate the effectiveness of denosumab for the reduction of clinical fractures.
• Outcomes:
  • Effectiveness outcome o Hip fracture • Safety outcomes: o Osteonecrosis of the jaw o Atypical femur fracture o Hypocalcemia, • Effectiveness outcomes: o Clinical vertebral fracture o Non-vertebral fracture (hip, wrist, forearm, humerus)
• Data analysis plan:
  This study includes both a descriptive analysis for safety endpoints and a comparative analysis for effectiveness endpoints