Study type

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Pharmacodynamic study, prospective, observational study
Study drug and medical condition

Name of medicine

XGEVA

Study drug International non-proprietary name (INN) or common name

DENOSUMAB

Anatomical Therapeutic Chemical (ATC) code

(M05BX04) denosumab
denosumab

Medical condition to be studied

Metastases to bone
Population studied

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

1000
Study design details

Main study objective

Describe utilization of XGEVA® and ZOMETA® for prevention of skeletal-related events (SREs) in participants with bone metastases secondary to breast, prostate, lung cancer; assess baseline characteristics/prognosis for SREs at initiation of bone targeting agent (BTA); and adverse events of special interest. Describe effectiveness of XGEVA® and ZOMETA® for preventing symptomatic SRE.

Outcomes

The frequency of administration and duration of treatment by XGEVA® and ZOMETA®, Demographic and clinical characteristics of patients that may be related to prognosis for SRE by treatment cohort (XGEVA® and ZOMETA®), Adverse events of special interest (ie, osteonecrosis of the jaw, atypical femoral fracture and hypocalcemia). Time to first symptomatic SRE.

Data analysis plan

Descriptive analyses will be performed to gain an understanding of the qualitative and quantitative nature of the data collected and the characteristics of the patient population and treatment cohorts. Continuous variables will be reported as mean, standard deviation (SD), median, range, and interquartile range (Q1 to Q3), where appropriate. Categorical variables will be summarized as frequency counts and percentage.