Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Retrospective, observational cohort study
Study drug and medical condition

Name of medicine

PROLIA

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

DENOSUMAB

Anatomical Therapeutic Chemical (ATC) code

(M05BX04) denosumab
denosumab

Medical condition to be studied

Osteoporosis postmenopausal
Population studied

Age groups

Elderly (≥ 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

585334
Study design details

Main study objective

The main objective of this study is to evaluate the comparative effectiveness of osteoporosis treatments on the incidence of major osteoporotic fractures, non-vertebral fractures, vertebral fracture, and hip fractures among post-menopausal women.

Outcomes

• Major osteoporotic fracture is defined as non-vertebral fractures or clinical vertebral fractures
• Non-vertebral fracture sites include: pelvis, humerus, radius/ulna, hip, other femur
• Clinical vertebral fracture
• Hip Fracture

Data analysis plan

Cumulative incidence of the outcomes of interest will be described for all the treatment cohorts of interest and measures of effect (i.e. relative risk and risk difference) will be assessed for the pairwise comparisons. Summary statistics will be computed on demographics, clinical factors, and treatment history in each treatment cohort of interest.