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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Biological: Denosumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Women with a clinical diagnosis of postmenopausal osteoporosis Decision has been made to treat with denosumab 60 mg once every 6 months Have received their first injection of denosumab within 8 weeks prior to enrolling in this study. Appropriate written informed consent has been obtained (as required per local country regulations) Exclusion Criteria Participating in ongoing or have participated in previous denosumab clinical trials Participation in other clinical or device trials in the last 6 months Contra-indicated for treatment with Prolia® according to the approved applicable local product label. 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Denosumab<br>Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia. | Biological: Denosumab<br>* This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.<br>* Other names: Prolia®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 
| Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection |  | 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. | 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 |  | 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. | 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. | Month 6 | 
| 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. | 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. | 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. | Month 24 | 
| Number of Denosumab Post-baseline Injections Received by Each Participant |  | 24 months | 
| Number of Participants Having Radiologic Bone Assessments | Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study. | 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. | Pre-baseline (before first denosumab injection) and post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 24 months |