The use and safety of XGEVA or Zoledronic acid in clinical practice among Chinese patients with bone metastases from breast, lung, or prostate cancer – a retrospective cohort study within Taiwan’s Health Insurance Research Database (20190412)

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

  Drug utilisation
• 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:
  XGEVA
• Study drug International non-proprietary name (INN) or common name:
  ZOLEDRONIC ACID
• Medical condition to be studied:
  Lung cancer metastatic

  Prostate cancer metastatic

  Breast cancer metastatic

  Metastases to bone

Population studied

• Short description of the study population:
  The study population included patients 18 years or older diagnosed with bone metastasis (BM) secondary to breast, prostate, or lung cancer received treatment with XGEVA or Zoledronic acid between January 1, 2013 and December 31, 2017 identified from the Taiwan’s National Health Insurance Research Database (NHIRD).; Inclusion criteria:; • Diagnosis of BM secondary to breast, prostate, or lung cancer and prior to initial use of XGEVA or Zoledronic acid. ; • New user of XGEVA or Zoledronic acid during study period (January 1, 2013 to December 21, 2016) ; o New user of either therapy will be defined as not having been treated with any bone targeting agent therapy prior to treatment initiation with XGEVA or Zoledronic acid. ; • At least one year of data available prior to initial administration of XGEVA or Zoledronic acid. ; • 18 or older at diagnosis of BM.; ; Exclusion criteria: ; • Patients with diagnosis of giant cell tumor of the bone, or multiple myeloma (to ensure that included subjects are receiving XGEVA for the indication of the treatment of BM from solid tumors).; • Evidence of XGEVA or Zoledronic acid use prior to BM diagnosis.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with bone metastasis
• Estimated number of subjects:
  6000

Study design details

• Main study objective:
  To describe the use of XGEVA and Zoledronic acid in Chinese patients with breast, lung or prostate cancer following diagnosis of incident bone metastases. The study also will characterize safety of XGEVA as measured by the incidence of osteonecrosis of the jaw (ONJ), atypical femur fracture (AFF), and hypocalcemia.
• Outcomes:
  Mean number XGEVA or Zoledronic acid prescriptions per patient Treatment duration from first dose to last dose of XGEVA or Zoledronic acid Proportion of patients discontinuing XGEVA or Zoledronic acid for more than 90 days Proportion of patients who switch therapies Time from initial therapy to the switching of therapy Incidences of ONJ, AFF, and hypocalcemia per 100 person years
• Data analysis plan:
  Primary objective #1 (use of XGEVA or Zoledronic acid) is descriptive and formal hypothesis testing will not be implemented. Primary objective #2 (safety of XGEVA) will estimate the incidence rates of three important identified risk factors in the Global Risk Management Plan for XGEVA, including ONJ, AFF, and hypocalcemia.

Documents

Study results

20190412 Observational Research Study Report Published Report_Redacted