Prospective Observational Study to Describe Characteristics and Management of Patients Treated With Denosumab (Prolia®) in Routine Clinical Practice
4 maart 2019 bijgewerkt door: Amgen
Prospective Observational Study to Describe Characteristics and Management of Patients With Postmenopausal Osteoporosis Treated With Prolia® in Routine Clinical Practice
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Werkelijk)
600
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Banska Bystrica, Slowakije, 974 01
- Research Site
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Bratislava, Slowakije, 826 06
- Research Site
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Bratislava, Slowakije, 833 05
- Research Site
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Humenne, Slowakije, 066 01
- Research Site
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Kosice, Slowakije, 040 01
- Research Site
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Kosice-Saca, Slowakije, 040 15
- Research Site
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Lubochna, Slowakije, 034 91
- Research Site
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Lucenec, Slowakije, 984 01
- Research Site
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Martin, Slowakije, 036 01
- Research Site
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Nitra, Slowakije, 949 01
- Research Site
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Presov, Slowakije, 080 01
- Research Site
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Trnava, Slowakije, 917 75
- Research Site
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Zilina, Slowakije, 010 01
- Research Site
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Brno, Tsjechië, 602 00
- Research Site
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Brno, Tsjechië, 638 00
- Research Site
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Ceske Budejovice, Tsjechië, 370 01
- Research Site
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Havlickuv Brod, Tsjechië, 580 22
- Research Site
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Karlovy Vary, Tsjechië, 367 17
- Research Site
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Kutna Hora, Tsjechië, 284 01
- Research Site
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Ostrava, Tsjechië, 702 00
- Research Site
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Ostrava-Trebovice, Tsjechië, 722 00
- Research Site
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Plzen, Tsjechië, 323 00
- Research Site
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Praha 11, Tsjechië, 148 00
- Research Site
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Praha 2, Tsjechië, 128 50
- Research Site
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Praha 4 - Nusle, Tsjechië, 140 00
- Research Site
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Trutnov, Tsjechië, 541 21
- Research Site
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Vsetin, Tsjechië, 755 01
- Research Site
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Zlin, Tsjechië, 760 01
- Research Site
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Zlin, Tsjechië
- Osteocentrum Zlin
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
The study was conducted at various study centers in the Czech Republic and Slovakia.
Postmenopausal women with osteoporosis who receive an injection of denosumab and meet the inclusion/exclusion criteria will be eligible to participate in the study.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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Denosumab
Patients with postmenopausal osteoporosis (PMO) who received at least 1 injection of denosumab 60 mg subcutaneously in the Czech Republic and Slovakia.
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This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office
Tijdsspanne: 24 months
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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.
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24 months
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Number of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual Injection
Tijdsspanne: Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Baseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Number of Participants Receiving All Prescriptions and Injections of Denosumab
Tijdsspanne: Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.
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Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
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Number of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care
Tijdsspanne: 24 months
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24 months
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Types of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline Injection
Tijdsspanne: Baseline (day 1)
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.
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Baseline (day 1)
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Types of Health Care Providers Administering Denosumab at the First Post-baseline Injection
Tijdsspanne: Month 6
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.
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Month 6
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Types of Health Care Providers Administering Denosumab at the Second Post-baseline Injection
Tijdsspanne: Month 12
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.
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Month 12
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Types of Health Care Providers Administering Denosumab at the Third Post-baseline Injection
Tijdsspanne: Month 18
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.
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Month 18
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Types of Health Care Providers Administering Denosumab at the Fourth Post-baseline Injection
Tijdsspanne: Month 24
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Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.
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Month 24
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Number of Denosumab Post-baseline Injections Received by Each Participant
Tijdsspanne: 24 months
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24 months
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Number of Participants Having Radiologic Bone Assessments
Tijdsspanne: Pre-baseline (before first denosumab injection) and during the study (post-baseline)
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Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.
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Pre-baseline (before first denosumab injection) and during the study (post-baseline)
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Number of Participants Having Osteoporosis Related Laboratory Examinations
Tijdsspanne: Pre-baseline (before first denosumab injection) and post-baseline
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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.
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Pre-baseline (before first denosumab injection) and post-baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants With Adverse Drug Reactions (ADRs) to Denosumab
Tijdsspanne: 24 months
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Adverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).
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24 months
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Number of Participants With Serious ADRs to Denosumab
Tijdsspanne: 24 months
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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.
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24 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
26 juni 2012
Primaire voltooiing (Werkelijk)
15 mei 2015
Studie voltooiing (Werkelijk)
15 mei 2015
Studieregistratiedata
Eerst ingediend
26 juli 2012
Eerst ingediend dat voldeed aan de QC-criteria
26 juli 2012
Eerst geplaatst (Schatting)
30 juli 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 maart 2019
Laatste update ingediend die voldeed aan QC-criteria
4 maart 2019
Laatst geverifieerd
1 maart 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20110132
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