Integrated Retrospective Analysis of Metastatic-related and Non metastatic-related Fractures in Studies 20050136, 20050244, and 20050103

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

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

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DENOSUMAB
• Medical condition to be studied:
  Bone cancer metastatic

Population studied

• Short description of the study population:
  Subjects with bone metastases from solid tumors.; All subjects randomized on Studies 20050136, 20050103, and 20050244 (excluding 179 subjects with multiple myeloma) will be included in the analysis.
• Age groups:
  Adults (18 to < 46 years)

  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:
  Solid tumors patients with bone metastases
• Estimated number of subjects:
  5723

Study design details

• Main study objective:
  To characterize the on-study metastatic and non-metastatic fractures seen in studies 20050136, 20050244 and 20050103
• Outcomes:
  The primary objective is to characterize the on-study metastatic and non-metastatic fractures seen in the 20050136, 20050244 and 20050103 studies. Location of non metastatic fracture (vertebral vs non-vertebral) and fracture CTCAE grades will be assessed. The secondary objective is to describe baseline medications known to reduce bone mineral density (BMD) and/or a history of osteoporosis in those patients experiencing a non-metastatic fracture.
• Data analysis plan:
  The statistical analysis in this study will be descriptive in nature. Categorical outcomes will be summarized by the number and percentage of subjects or events in each category. Continuous outcomes will be summarized by the number of nonmissing values, mean, standard deviation, median, lower and upper quartiles, minimum, and maximum.