The use, safety, and effectiveness of Prolia in clinical practice among Chinese women with post-menopausal osteoporosis ─ Taiwan and Hong Kong (20180325)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

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 includes women aged 55 years or older (i.e., postmenopausal) who received at least one dose of Prolia. To ensure that included women are receiving Prolia for the indication of PMO, all are excluded with a history of Paget’s disease or malignancy. To be representative of all patients being treated with Prolia in clinical practice, there are no other exclusion criteria.; Inclusion Criteria; - Use of Prolia in clinical practice; - Complete data available on age and sex; Exclusion Criteria; - Males; - Less than 55 years old at initial use of Prolia; - History of any malignancy within 1 year before initial use of Prolia; - 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Osteoporosis patients
• Estimated number of subjects:
  40000

Study design details

• Main study objective:
  Among Chinese women being treated in clinical practice for post-menopausal osteoporosis, the objectives are to:1. Describe the use of denosumab and the patient characteristics2. Characterize the safety of denosumab 3. Evaluate the effectiveness of denosumab for the reduction of clinical osteoporotic fractures
• Data analysis plan:
  Risk estimation

Documents

Study results

01.42.03_csr-20180325-observational research study report- abstract_public-redacted