Prospective Observational Study to Describe Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France and its use in Routine Clinical Practice (20130240)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective Observational 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

Population studied

• Short description of the study population:
  Postmenopausal women with osteoporosis who receive a prescription of Prolia® in France.
• 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:
  Osteoporosis patients
• Estimated number of subjects:
  775

Study design details

• Main study objective:
  To evaluate the persistence with Prolia® at 12 months in postmenopausal women with osteoporosis (PMO) in France
• Outcomes:
  To evaluate the persistence with Prolia® at 12 months in postmenopausal women with osteoporosis (PMO) in France, To describe the characteristics of PMO women in France treated with Prolia®, the use in routine clinical practice and persistence for two successive years
• Data analysis plan:
  Analyses are descriptive. In general, data summaries will be presented by wave (ie, wave 1 and 2 will not be combined) and subgroups of interest. Categorical outcomes will be summarized by the number and percentage of patients in each category. Continuous outcomes will be summarized by the number of non-missing values, mean, standard deviation, median, lower and upper quartiles, and minimum andmaximum values.

Documents

Study results

20130240_Final ORSR Abstract