A Real-world, Prospective, Observational Study of Prolia® (20180401)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Real-world, observational, multi-center 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 postmenopausal
• Additional medical condition(s):
  Postmenopausal Osteoporosis (PMO)

Population studied

• Short description of the study population:
  The study population comprises patients treated with Prolia in a clinical setting which includes any primary through tertiary healthcare setting where Prolia is prescribed.
• 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:
  Hepatic impaired

  Immunocompromised

  Renal impaired
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  To assess the safety of Prolia® in PMO subjects according to the China Prescribing Information in a post-marketing setting.
• Outcomes:
  The primary outcomes are to estimate the incidence rates of adverse events, serious adverse events, and ADRs among postmenopausal subjects receiving Prolia® according to the China Prescribing Information (PI) in a post-marketing setting. The secondary outcomes of the study are: percent change from baseline in BMD of the lumbar spine and/or total hip and/or femoral neck. Incidence of clinical fractures during the treatment with Prolia® characteristics of subjects receiving Prolia® in the post-marketing setting.
• Data analysis plan:
  Descriptive analysis of the collected safety and effectiveness endpoints will be conducted. No hypothesis testing will be performed. Categorical outcomes will be summarized by the number and percentage of subjects in each category. Continuous outcomes will be summarized by the number of nonmissing values, mean, standard deviation, median, lower and upper quartiles, and minimum and maximum values. For the incidence, 95% CI will be presented based on an exact method.