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)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

DENOSUMAB

Medical condition to be studied

Osteoporosis
Population studied

Short description of the study population

The study population includes men aged 50 years or older who received at least one dose of Prolia. To ensure that included men who were receiving Prolia for the indication of MOP, all with a history of Paget’s disease or malignancy are excluded.

Inclusion Criteria
1. Men ( ≥ 50 years old) in Taiwan’s Health Insurance Research Database
2. Receipt of at least 1 administration of denosumab
3. Complete age and gender information

Exclusion Criteria
1. History of any malignancy within 1 year before initial use of Prolia
2. 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)

Estimated number of subjects

16000
Study design details

Main study objective

This real-world study of the clinical practice of Taiwan aims to characterize the safety and evaluate the effectiveness of Prolia among Chinese men with osteoporosis.

Outcomes

Effectiveness outcome: hip fracture, Safety outcomes: osteonecrosis of the jaw, atypical femur fracture, hypocalcemia, Clinical vertebral fracture, Non-vertebral fracture (hip, wrist, forearm, humerus), Major osteoporotic fracture (clinical vertebral, hip, wrist, forearm, humerus)

Data analysis plan

This study includes both a descriptive analysis for safety endpoints and a comparative analysis for effectiveness endpoints.
Documents
Study results
English (305.79 KB - PDF)View document