Comparative Effectiveness of Osteoporosis Medications Among Female Medicare Fee-For-Service (FFS) Beneficiaries in the United States (20210028)

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.