Postmarketing Surveillance Study of Prolia (Denosumab) in South Korea

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)

  Safety study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Efficacy of a product with marketing authorization
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  A prospective, observational, multicenter, post-marketing surveillance 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 comprises patients treated with Prolia in a clinical setting which includes any primary through tertiary healthcare setting where Prolia is prescribed.; Patients will be screened for eligibility, receive a single dose of Prolia during their initial visit/day 1 (which could be the same day as screening), and return for follow-up visits at the discretion of the investigator based on the patient’s course of treatment.; Inclusion Criteria; • Patients who receive Prolia (on-label) in the postmarketing setting in South Korea.; • Willing to provide access to previous and future medical information.; • Patients who consent to participate in this study.; Exclusion Criteria; • Patients unwilling to provide consent.; • Patients with hypocalcemia.; • Patients who are pregnant.; • Patients with known hypersensitivity to denosumab or any of its components.
• 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:
  Osteoporosis patients
• Estimated number of subjects:
  3000

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 Prolia® in a postmarketing setting as required by the MFDS.
• Outcomes:
  Incidence of adverse events and adverse drug reactions (including seriousness and causality to drug), inclusive of reaction at local injection sites, will be collected as they become available throughout the follow-up period and reported. Subject level incidence will be reported and summarized by classification according to the adverse event coding, (1) Percent change from baseline in BMD at 12 months (measured by DXA scan) of the lumbar spine, total hip, and femoral neck. (2) Describe characteristics of patients receiving Prolia® in the postmarketing setting
• Data analysis plan:
  Descriptive analysis of the collected safety and efficacy endpoints will be conducted at interim analyses (every 6 months for the first 2 years from approval, then annually thereafter) and final analysis when all patients have the opportunity to complete the final study visit. Categorical outcomes will be summarized by the number and percentage of subjects in each category. Continuous outcomes will be summarized by the number of nonmissing values, mean, standard deviation, median, lower and upper quartiles, and minimum and maximum values. For the incidence, 95% confidence interval (CI) will be presented based on an exact method. The analysis will include all enrolled patients (enrollment is triggered once an eligible, consenting patient receives their first dose of Prolia®).

Documents

Study results

Prolia_Abstract_Final_18Dec2020