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.
Study Type
OBSERVATIONAL
Enrollment
600
This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
Research Site
Brno, Czechia
Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
Number of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.
Time frame: 24 months
Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection
Time frame: Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
Number of Participants Receiving All Prescriptions and Injections of Denosumab
Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.
Time frame: Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care
Time frame: 24 months
Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.
Time frame: Baseline (day 1)
Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.
Time frame: Month 6
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Research Site
Brno, Czechia
Research Site
České Budějovice, Czechia
Research Site
Havlíčkův Brod, Czechia
Research Site
Karlovy Vary, Czechia
Research Site
Kutná Hora, Czechia
Research Site
Ostrava, Czechia
Research Site
Ostrava-Trebovice, Czechia
Research Site
Pilsen, Czechia
Research Site
Prague, Czechia
...and 19 more locations
Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.
Time frame: Month 12
Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.
Time frame: Month 18
Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection
Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.
Time frame: Month 24
Number of Denosumab Post-baseline Injections Received by Each Participant
Time frame: 24 months
Number of Participants Having Radiologic Bone Assessments
Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.
Time frame: Pre-baseline (before first denosumab injection) and during the study (post-baseline)
Number of Participants Having Osteoporosis Related Laboratory Examinations
Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.
Time frame: Pre-baseline (before first denosumab injection) and post-baseline
Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).
Time frame: 24 months
Number of Participants With Serious ADRs to Denosumab
Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an "other significant medical hazard" that does not meet any of the above criteria.
Time frame: 24 months