Prospective Observational Study to Describe Characteristics and Management of Patients With Osteoporosis Treated With Prolia® in Routine Clinical Practice in Poland (20160178)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Characteristics of patients treated with Prolia in routine clinical practice in Poland during the 12 months of treatment
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

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

Study drug and medical condition

• Name of medicine:
  PROLIA
• Medical condition to be studied:
  Osteoporosis

Population studied

• Short description of the study population:
  Osteoporosis patients population who received at least one injection of Prolia® 60 mg Q6M, SC (subcutaneous) in Poland.; ; Patients will meet the following inclusion criteria at enrollment into the observational; study:; 1. Women with a clinical diagnosis of PMO or men with diagnosis of osteoporosis, have received their first injection of Prolia® within 8 weeks prior to enrolling in this study; 2. Decision has been made to treat patient with Prolia® 60 mg once every 6 months; 3. Appropriate written informed consent has been obtained; ; Patients meeting the following exclusion criteria are not eligible to participate in the observational study:; 1. Patients who are participating in ongoing or have participated denosumab clinical trials in the past; 2. Participation in other clinical or device trials in the last 6 months; 3. Contra-indication for treatment with Prolia®; 4. Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
• 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)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  The objective of this prospective, observational study in Poland is to describe characteristics of patients treated with Prolia® in routine clinical practice in Poland during the 12 months of treatment
• Outcomes:
  Description of osteoporosis patient population treated with Prolia®: socio-demographic landscape, disease related data, treatment patterns with Prolia®, safety data
• Data analysis plan:
  This is an observational study for which the analysis will be descriptive in nature and no formal hypothesis will be tested.Frequency distributions will be described for categorical variables. Continuous variables will be summarized by the number of non-missing values, mean, standard deviation, median, lower and upper quartiles and minimum and maximum values