Clinical Characteristics, Including History of MI and Stroke, Among US Post-menopausal Women Initiating Treatment With Romosozumab and Other Anti-osteoporosis Therapies (20190205)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Characterize patients baseline clinical characteristics

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective, repeated analysis design

Study drug and medical condition

• Name of medicine:
  EVENITY
• Name of medicine, other:
  Zolendronic acid; Oral bisphosphonates
• Study drug International non-proprietary name (INN) or common name:
  ABALOPARATIDE

  ALENDRONIC ACID

  DENOSUMAB

  ROMOSOZUMAB

  TERIPARATIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (H05AA02) teriparatide

  teriparatide

  (H05AA04) abaloparatide

  abaloparatide

  (M05BX04) denosumab

  denosumab

  (M05BX06) romosozumab

  romosozumab
• Medical condition to be studied:
  Osteoporosis postmenopausal

Population studied

• Age groups:
  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:
  Post-menopausal women
• Estimated number of subjects:
  122259

Study design details

• Main study objective:
  This study is designed to fulfil US FDA post-marketing requirements
• Outcomes:
  Describe demographic and clinical characteristics, including history of cardiovascular disease (e.g., MI, stroke), cardiovascular risk factors, osteoporotic fracture, risk factors for osteoporosis and osteoporotic fracture, other comorbidities, concomitant medication use, and healthcare utilization all available historical data preceding initiation of romosozumab or other anti-osteoporosis medication, Repeat primary objective analyses in secondary datasets (Medicare claims linked to PCORnet Clinical Data Research Network (CDRN) data, and Optum claims – Optum EHR linked dataset).
• Data analysis plan:
  All planned statistical analyses are descriptive, no hypothesis testing will be conducted. All study objectives for the primary analysis will be assessed separately in each primary data source, i.e., FFS Medicare and Optum CDM claims data. Categorical variables will be presented in tabular form as number and percentage, continuous variables will be presented as number, mean with standard deviation, and median with interquartile range. Differences in clinical characteristics will be described in four pairwise exposure groups: 1) romosozumab vs. denosumab, 2) romosozumab vs. PTH analog (teriparatide or abaloparatide), 3) romosozumab vs. zolendronate, 4) romosozumab vs. oral BPs. Standardized mean difference (SMD) will be used to characterize differences between exposure groups.