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
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