Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
Study Details
The objective of this prospective, observational study in Czech Republic and Slovakia is to describe per country the characteristics of women treated with denosumab in routine clinical practice and the clinical management of these patients during the first 2 years of treatment. In addition, the study aims to collect safety data in the real-life clinical practice settings on adverse drug reactions (ADRs) and serious ADRs.
Protocol Summary
Incidence (yes/no) of patients receiving all prescriptions and injections of Prolia® from the initial prescribing physician’s office
Timeframe: 24 months from 1st Prolia® injection received
Incidence (yes/no) of patients receiving an individual prescription and injection of Prolia® from the initial prescribing physician office by each individual injection
Timeframe: 24 months from 1st Prolia® injection received
Incidence (yes/no) of patients receiving all prescriptions and injections of Prolia®, whether or not the injections are given at the initial prescribing physician’s office
Timeframe: 24 months from 1st Prolia® injection received
Incidence (yes/no) of patients with a referral by the prescribing physician to other health care providers for continuation or follow up of care by type of physician
Timeframe: 24 months from 1st Prolia® injection received
Types of health care providers administering an individual injection of Prolia® inside or outside the initial prescribing office by injection
Timeframe: 24 months from 1st Prolia® injection received
Number of Prolia® injections received by each patient during the follow-up period
Timeframe: 24 months from 1st Prolia® injection received
Incidence (yes/no) of patients having radiologic bone assessments pre-treatment with Prolia®, and during the study
Timeframe: 24 months from 1st Prolia® injection received
Incidence (yes/no) of patients having osteoporosis related laboratory examinations pre-treatment with Prolia®, and during the study.
Timeframe: 24 months from 1st Prolia® injection received
Incidence (yes/no) of patients with ADR to Prolia®.
Timeframe: 24 months from 1st Prolia® injection received
Incidence (yes/no) of patients with serious ADR to Prolia®.
Timeframe: 24 months from 1st Prolia® injection received