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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective, observational cohort study

Study drug and medical condition

• Medicinal product name:
  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

• Short description of the study population:
  We included female patients in this study if they met all of the following criteria: ; • Use of denosumab, an oral BP (alendronate, ibandronate, risedronate) or ZA with at least one outpatient pharmacy claim for one of these medications ; o Date of prescription between January 1, 2012 through December 31, 2018 ; • 66 years + 90 days (3 mo.) of age or older on the date of treatment initiation ; • At least 15 months (455 days) of continuous health plan enrollment preceding the date ; of treatment initiation ; We excluded patients from the study if they had a history of the following criteria during the 455-day baseline period: ; • Paget’s disease of bone, ; • Cancer (excluding non-melanoma skin cancer), ; • Treatment with chemotherapy, ; • Treatment with hormonal therapy for cancer, ; • Treatment with radiation therapy for cancer, ; • Exposed to > 1 OP drug (including any combination of study medications, teriparatide, abaloparatide, raloxifene, calcitonin, pamidronate, and etidronate) at treatment initiation (index date)
• 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

• Study design:
  A retrospective cohort study.
• 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.
• Setting:
  The database was extracted from the US Centers for Medicare and Medicaid Services’ Chronic Condition Warehouse database from January 1, 2012 through December 31, 2019.
• Comparators:
  Pairwise treatment comparisons for the three treatment cohorts listed above will include: denosumab vs. alendronate, denosumab vs. oral BP (alendronate, ibandronate, risedronate), denosumab vs. IV ZA
• 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.