Prolia® Postmarketing Active Safety Surveillance Program for Soliciting Adverse Events of Special Interest in the United States (PASP-EMR Program)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Postmarketing Active Safety Surveillance Program

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Men and postmenopausal women with osteoporosis receiving Prolia for the treatment identified from the Postmarketing Active Safety Surveillance Program (PASP) Electronic Medical Record (EMR) (PASP-EMR program).
• 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:
  5000

Study design details

• Main study objective:
  To monitor the long-term safety of Prolia® (denosumab) and enhance the quality of data collection by proactively soliciting adverse event (AE) reporting of the 5 pre-specified AEs of special interest (AESI) from United States (US) health care providers (HCP e.g. licensed registered nurses, nurse practitioners, or physician assistants) of Prolia treated postmenopausal women and men with osteoporos
• Data analysis plan:
  Descriptive statistics will be used to summarize the program data. Summary data to be estimated and reported include number of Prolia-treated patients in the electronic medical record(EMR) platform, number and percentage of Prolia-treated with at least 1 AESI-soliciting questionnaire presented and completed, number and perecentage of Prolia-treated patients with at least 1 AESI reported through the EMR platform, number of AESIs reported through a secure Amgen website via a link from the EMR platform and incidence rates for AESIs. Data will be computed and reported annually.

Documents

Study results

denosumab 20090601 Observational Final Analysis Abstract