Completed
Prospective Observational Study to Evaluate Medication-taking Behavior With Denosumab (Prolia) and Patient Characteristics in Postmenopausal Women With Osteoporosis in Routine Clinical Practice in Germany, Austria, Greece and Belgium
What is being collected
Data Collection
Collected from today forward - ProspectiveWho is being recruted
Bone Diseases+4
+ Bone Diseases, Metabolic
+ Metabolic Diseases
+7 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: November 2011
Summary
Principal SponsorAmgen
Last updated: January 30, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: November 28, 2011
Actual date on which the first participant was enrolled.The decision to treat patients with denosumab was made independent of and before their enrolment in the study. No study drug was administered as part of the study.
Principal SponsorAmgen
Last updated: January 30, 2018
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
1501 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Bone DiseasesBone Diseases, MetabolicMetabolic DiseasesMusculoskeletal DiseasesNutritional and Metabolic DiseasesOsteoporosisOsteoporosis, Postmenopausal
Criteria
3 inclusion criteria required to participate
Appropriate written informed consent has been obtained (as required per local country regulations)
Enrolled into the study within 4 weeks of receiving their first injection of Prolia according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium)
Indicated for treatment of osteoporosis in postmenopausal women at increased risk of fractures according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium)
4 exclusion criteria prevent from participating
Contraindicated for treatment with Prolia according to the approved Regional Prescribing Information (eg, EU SmPC in Germany, Austria, Greece and Belgium)
Participation in ongoing or previous denosumab clinical trials
Patient has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent
Patient is currently enrolled in or has been enrolled within the prior 6 months in a study involving any investigational procedure, device or drug
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 144 locations
Research Site
Graz, AustriaResearch Site
Klagenfurt, AustriaResearch Site
Landeck, AustriaCompleted144 Study Centers